Safety, Tolerability and Pharmacokinetics of Efavirenz in HIV-Infected Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00364793
First received: August 15, 2006
Last updated: April 11, 2014
Last verified: April 2014
Results First Received: March 6, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV Infections
Intervention: Drug: Efavirenz (EFV) + Didanosine (ddI) + Emtricitabine (FTC)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study initiated February 2007 and completed July 2013. All participants enrolled in countries where efavirenz (EFV) oral solution was not commercially available could remain on study until their 7th birthday or until they were able to swallow EFV capsules (whichever occurred first).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
56 participants were enrolled but 19 were never treated. Reasons for not treating: 2 deaths, 1 lost to follow up, 6 other (not specified), 9 no longer met study criteria, 1 withdrew consent.

Reporting Groups
  Description
EFV+ddI+FTC in Infants >=3 Months to < 6 Months EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and emtricitabine (FTC) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Infants >=6 Months to < 2 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Children >= 2 Years to < 3 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Children >= 3 Years to <= 6 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.

Participant Flow:   Overall Study
    EFV+ddI+FTC in Infants >=3 Months to < 6 Months     EFV+ddI+FTC in Infants >=6 Months to < 2 Years     EFV+ddI+FTC in Children >= 2 Years to < 3 Years     EFV+ddI+FTC in Children >= 3 Years to <= 6 Years  
STARTED     15     10     4     8  
COMPLETED     7     5     0     5  
NOT COMPLETED     8     5     4     3  
Adverse Event                 2                 0                 0                 0  
Death                 1                 0                 1                 0  
Lack of Efficacy                 3                 3                 1                 1  
Lost to Follow-up                 1                 0                 2                 0  
Poor or non-compliance                 1                 1                 0                 1  
No longer meets criteria                 0                 0                 0                 1  
Withdrawal by Subject                 0                 1                 0                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated participants who received at least one dose of study drug (EFV) were analyzed.

Reporting Groups
  Description
EFV+ddI+FTC in Infants >=3 Months to < 6 Months EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Infants >=6 Months to < 2 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Children >= 2 Years to < 3 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Children >= 3 Years to <= 6 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
Total Total of all reporting groups

Baseline Measures
    EFV+ddI+FTC in Infants >=3 Months to < 6 Months     EFV+ddI+FTC in Infants >=6 Months to < 2 Years     EFV+ddI+FTC in Children >= 2 Years to < 3 Years     EFV+ddI+FTC in Children >= 3 Years to <= 6 Years     Total  
Number of Participants  
[units: participants]
  15     10     4     8     37  
Age  
[units: years]
Median ( Full Range )
  0.392  
  ( 0.296 to 0.501 )  
  0.825  
  ( 0.586 to 1.906 )  
  2.313  
  ( 2.094 to 2.995 )  
  3.922  
  ( 2.998 to 6.976 )  
  0.663  
  ( 0.296 to 6.976 )  
Gender  
[units: participants]
         
Female     6     0     1     6     13  
Male     9     10     3     2     24  
Race/Ethnicity, Customized [1]
[units: participants]
         
White     3     9     4     8     24  
Black or African American     7     0     0     0     7  
Asian     2     0     0     0     2  
Other     3     1     0     0     4  
Region of Enrollment  
[units: participants]
         
Panama     3     0     0     1     4  
Mexico     2     7     3     7     19  
Argentina     0     3     1     0     4  
Thailand     2     0     0     0     2  
South Africa     7     0     0     0     7  
Colombia     1     0     0     0     1  
Human Immunodeficiency Virus (HIV) Ribonucleic acid (RNA) Viral Load (log10 c/mL) [2]
[units: log10 c/mL]
Median ( Full Range )
  5.88  
  ( 3.34 to 6.74 )  
  5.88  
  ( 2.12 to 5.88 )  
  5.88  
  ( 4.88 to 5.88 )  
  5.26  
  ( 3.38 to 5.88 )  
  5.88  
  ( 2.12 to 6.74 )  
HIV RNA Viral Load Category [3]
[units: participants]
         
< 30,000 copies/mL     3     1     0     1     5  
30,000 to <100,000 copies/mL     0     1     1     2     4  
100,000 to <500,000 copies/mL     2     1     0     2     5  
500,000 to <=750,000 copies/mL     1     1     0     1     3  
>750,000 copies/mL     9     6     3     2     20  
CD4 Cell Count (n=13, 9, 3, 7, 32) [4]
[units: cells/mm^3]
Median ( Full Range )
  1785  
  ( 200 to 3584 )  
  1569  
  ( 516 to 2879 )  
  517  
  ( 129 to 558 )  
  540  
  ( 11 to 1363 )  
  1144  
  ( 11 to 3584 )  
[1] Ethnicity was not collected because the study was conducted outside of the United States.
[2] Human immunodeficiency virus (HIV) ribonucleic acid (RNA) values ≥ 1,000 copies per milliliter (c/mL) were considered evidence of infection. HIV RNA measures the viral load and was first measured using the ultrasensitive and standard Roche Amplicor Polymerase Chain Reaction (PCR), version 1.5, and then the method of measurement was switched to the COBAS AmpliPrep/COBAS TaqMan HIV IVD method.
[3] Human immunodeficiency virus (HIV) ribonucleic acid (RNA) values greater than, equal to (≥) 1,000 copies per milliliter (c/mL) were considered evidence of infection. Categories listed indicate the plasma viral load prior to study treatment (Baseline). HIV RNA was first measured using the ultrasensitive and standard Roche Amplicor PCR, version 1.5, and then the method of measurement was switched to the COBAS AmpliPrep/COBAS TaqMan HIV IVD method.
[4] A CD4 cell is an antigenic marker of helper/inducer T cells. These cells were counted during the hematology cell counts performed during a Complete Blood Cell count (CBC) performed by the Central Laboratory. CD4 are measured as number of cells per millimeter to the third power (cells/mm^3). Not all treated participants provided a measurement for this baseline parameter (n=number of participants with this baseline measurement).



  Outcome Measures
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1.  Primary:   Maximum Observed Plasma Concentration (Cmax) and Plasma Concentration 24 Hours Post-dose (Cmin) of EFV at Week 2 - Pharmacokinetic Evaluable Population   [ Time Frame: Week 2 ]

Measure Type Primary
Measure Title Maximum Observed Plasma Concentration (Cmax) and Plasma Concentration 24 Hours Post-dose (Cmin) of EFV at Week 2 - Pharmacokinetic Evaluable Population
Measure Description Cmax and Cmin were derived from plasma concentrations versus time using a validated liquid chromatography tandem mass spectrometry method (LC-MS/MS). The lower limit of quantification (LLOQ) for EFV was 10.0 nanograms per milliliter (ng/mL) and the upper limit of quantification (ULOQ) was 8,000 ng/mL. Cmax and Cmin were recorded directly from experimental observations. Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters were summarized using geometric means. Cmax and Cmin were measured in ng/mL.
Time Frame Week 2  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who received at least one dose of study drug (EFV) and had adequate pharmacokinetic (PK) profiles were analyzed.

Reporting Groups
  Description
EFV+ddI+FTC in Infants >=3 Months to < 6 Months EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Infants >=6 Months to < 2 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Children >= 2 Years to < 3 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Children >= 3 Years to <= 6 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.

Measured Values
    EFV+ddI+FTC in Infants >=3 Months to < 6 Months     EFV+ddI+FTC in Infants >=6 Months to < 2 Years     EFV+ddI+FTC in Children >= 2 Years to < 3 Years     EFV+ddI+FTC in Children >= 3 Years to <= 6 Years  
Number of Participants Analyzed  
[units: participants]
  3     10     3     7  
Maximum Observed Plasma Concentration (Cmax) and Plasma Concentration 24 Hours Post-dose (Cmin) of EFV at Week 2 - Pharmacokinetic Evaluable Population  
[units: ng/mL]
Geometric Mean ( Geometric Coefficient of Variation )
       
Cmax     3790  
  ( 76% )  
  1998  
  ( 51% )  
  2167  
  ( 68% )  
  2632  
  ( 83% )  
Cmin     391  
  ( 141% )  
  445  
  ( 57% )  
  648  
  ( 75% )  
  1185  
  ( 111% )  

No statistical analysis provided for Maximum Observed Plasma Concentration (Cmax) and Plasma Concentration 24 Hours Post-dose (Cmin) of EFV at Week 2 - Pharmacokinetic Evaluable Population



2.  Primary:   Area Under the Plasma Concentration Time Curve (AUC) Over One Dosing Interval From Time Zero to 24 Hours Post-dose(TAU) at Week 2 - Pharmacokinetic Evaluable Population   [ Time Frame: Week 2 ]

Measure Type Primary
Measure Title Area Under the Plasma Concentration Time Curve (AUC) Over One Dosing Interval From Time Zero to 24 Hours Post-dose(TAU) at Week 2 - Pharmacokinetic Evaluable Population
Measure Description Plasma concentrations were obtained using a validated liquid chromatography tandem mass spectrometry method (LC-MS/MS). The lower limit of quantification (LLOQ) for EFV was 10.0 nanograms per milliliter (ng/mL) and the upper limit of quantification (ULOQ) was 8,000 ng/mL. AUC(TAU) was calculated by log- and linear trapezoidal summations. If a concentration was < LLOQ at time TAU, the value of the concentration at time TAU was estimated using the quotient of the last quantifiable concentration and λ. Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters summarized using geometric means. AUC(TAU) was measured in micromolars*time (µM•h).
Time Frame Week 2  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who received at least one dose of study drug (EFV) and had adequate pharmacokinetic (PK) profiles were analyzed.

Reporting Groups
  Description
EFV+ddI+FTC in Infants >=3 Months to < 6 Months EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Infants >=6 Months to < 2 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Children >= 2 Years to < 3 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Children >= 3 Years to <= 6 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.

Measured Values
    EFV+ddI+FTC in Infants >=3 Months to < 6 Months     EFV+ddI+FTC in Infants >=6 Months to < 2 Years     EFV+ddI+FTC in Children >= 2 Years to < 3 Years     EFV+ddI+FTC in Children >= 3 Years to <= 6 Years  
Number of Participants Analyzed  
[units: participants]
  3     10     3     7  
Area Under the Plasma Concentration Time Curve (AUC) Over One Dosing Interval From Time Zero to 24 Hours Post-dose(TAU) at Week 2 - Pharmacokinetic Evaluable Population  
[units: µM•h]
Geometric Mean ( Geometric Coefficient of Variation )
  129.5  
  ( 98% )  
  71.4  
  ( 49% )  
  93.8  
  ( 68% )  
  130.8  
  ( 98% )  

No statistical analysis provided for Area Under the Plasma Concentration Time Curve (AUC) Over One Dosing Interval From Time Zero to 24 Hours Post-dose(TAU) at Week 2 - Pharmacokinetic Evaluable Population



3.  Primary:   Apparent Oral Clearance (CLT/F) of EFV at Week 2 - Pharmacokinetic Evaluable Population   [ Time Frame: Week 2 ]

Measure Type Primary
Measure Title Apparent Oral Clearance (CLT/F) of EFV at Week 2 - Pharmacokinetic Evaluable Population
Measure Description Plasma concentrations of EFV were obtained using a validated liquid chromatography tandem mass spectrometry method (LC-MS/MS). The lower limit of quantification (LLOQ) for EFV was 10.0 nanograms per milliliter (ng/mL) and the upper limit of quantification (ULOQ) was 8,000 ng/mL. CLT/F was calculated by dividing the dose of EFV by AUC(TAU) of EFV. Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters were summarized using geometric means. CLT/F was measured in liters per hour (L/h).
Time Frame Week 2  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who received at least one dose of study drug (EFV) and had adequate pharmacokinetic (PK) profiles were analyzed.

Reporting Groups
  Description
EFV+ddI+FTC in Infants >=3 Months to < 6 Months EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Infants >=6 Months to < 2 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Children >= 2 Years to < 3 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Children >= 3 Years to <= 6 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.

Measured Values
    EFV+ddI+FTC in Infants >=3 Months to < 6 Months     EFV+ddI+FTC in Infants >=6 Months to < 2 Years     EFV+ddI+FTC in Children >= 2 Years to < 3 Years     EFV+ddI+FTC in Children >= 3 Years to <= 6 Years  
Number of Participants Analyzed  
[units: participants]
  3     10     3     7  
Apparent Oral Clearance (CLT/F) of EFV at Week 2 - Pharmacokinetic Evaluable Population  
[units: L/h]
Geometric Mean ( Geometric Coefficient of Variation )
  9.54  
  ( 63% )  
  19.69  
  ( 85% )  
  13.16  
  ( 58% )  
  9.11  
  ( 73% )  

No statistical analysis provided for Apparent Oral Clearance (CLT/F) of EFV at Week 2 - Pharmacokinetic Evaluable Population



4.  Primary:   Apparent Oral Clearance Adjusted for Body Weight (CLT/F/kg) of EFV at Week 2 - Pharmacokinetic Evaluable Population   [ Time Frame: Week 2 ]

Measure Type Primary
Measure Title Apparent Oral Clearance Adjusted for Body Weight (CLT/F/kg) of EFV at Week 2 - Pharmacokinetic Evaluable Population
Measure Description Plasma concentrations of EFV were determined using a validated liquid chromatography tandem mass spectrometry method (LC-MS/MS). The lower limit of quantification (LLOQ) for EFV was 10.0 nanograms per milliliter (ng/mL) and the upper limit of quantification (ULOQ) was 8,000 ng/mL. CLT/F/kg was calculated by dividing CLT/F by body weight in kilograms (kg). Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters were summarized using geometric means. CLT/F/kg was measured in liters per hour per kilogram (L/h/kg).
Time Frame Week 2  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who received at least one dose of study drug (EFV) and had adequate pharmacokinetic (PK) profiles were analyzed.

Reporting Groups
  Description
EFV+ddI+FTC in Infants >=3 Months to < 6 Months EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Infants >=6 Months to < 2 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Children >= 2 Years to < 3 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Children >= 3 Years to <= 6 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.

Measured Values
    EFV+ddI+FTC in Infants >=3 Months to < 6 Months     EFV+ddI+FTC in Infants >=6 Months to < 2 Years     EFV+ddI+FTC in Children >= 2 Years to < 3 Years     EFV+ddI+FTC in Children >= 3 Years to <= 6 Years  
Number of Participants Analyzed  
[units: participants]
  3     10     3     7  
Apparent Oral Clearance Adjusted for Body Weight (CLT/F/kg) of EFV at Week 2 - Pharmacokinetic Evaluable Population  
[units: L/h/kg]
Geometric Mean ( Geometric Coefficient of Variation )
  2.07  
  ( 71% )  
  2.36  
  ( 84% )  
  1.44  
  ( 51% )  
  0.66  
  ( 72% )  

No statistical analysis provided for Apparent Oral Clearance Adjusted for Body Weight (CLT/F/kg) of EFV at Week 2 - Pharmacokinetic Evaluable Population



5.  Secondary:   The Number of Participants With Plasma HIV RNA < 400 Copies Per Milliliter (c/mL) at Week 48 as Analyzed by Different Algorithms - All Treated Participants   [ Time Frame: Week 48 ]

Measure Type Secondary
Measure Title The Number of Participants With Plasma HIV RNA < 400 Copies Per Milliliter (c/mL) at Week 48 as Analyzed by Different Algorithms - All Treated Participants
Measure Description Algorithms: Confirmed Virologic Response (CVR) non-completer = failure (NC = F): participants were responders if they achieved confirmed HIV RNA < 400 c/mL at Week 48; participants were failures if virologic rebound occurred at or before Week 48; therapy discontinued before Week 48; no response by Week 48, or missing HIV RNA at Week 48 and beyond. Virologic Response - Observed Cases (VR-OC): participants were responders according to a single on-treatment HIV RNA < 400 c/mL closest to the planned Week 48 visit and within the predefined Week 48 visit window; those on treatment and missing their Week 48 measurement were responders only if previous and subsequent measurements to the Week 48 visit window were < 400 c/mL; denominator was all who remained on treatment through Week 48. Snapshot: participants were responders according to the last on-treatment HIV RNA < 400 c/mL in the predefined Week 48 visit window; denominator was all treated participants.
Time Frame Week 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated participants, who received at least 1 dose of study drug (EFV), were analyzed. n=number of participants with available on-treatment data for analysis by each algorithm.

Reporting Groups
  Description
EFV+ddI+FTC in Infants >=3 Months to < 6 Months EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Infants >=6 Months to < 2 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Children >= 2 Years to < 3 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Children >= 3 Years to <= 6 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
Total Participants All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years.

Measured Values
    EFV+ddI+FTC in Infants >=3 Months to < 6 Months     EFV+ddI+FTC in Infants >=6 Months to < 2 Years     EFV+ddI+FTC in Children >= 2 Years to < 3 Years     EFV+ddI+FTC in Children >= 3 Years to <= 6 Years     Total Participants  
Number of Participants Analyzed  
[units: participants]
  15     10     4     8     37  
The Number of Participants With Plasma HIV RNA < 400 Copies Per Milliliter (c/mL) at Week 48 as Analyzed by Different Algorithms - All Treated Participants  
[units: participants]
         
CVR (NC=F) n=15, 10, 4, 8, 37     7     6     3     5     21  
VR-OC n=9, 9, 3, 6, 27     7     6     3     5     21  
SNAPSHOT n=15, 10, 4, 8, 37     7     6     3     5     21  

No statistical analysis provided for The Number of Participants With Plasma HIV RNA < 400 Copies Per Milliliter (c/mL) at Week 48 as Analyzed by Different Algorithms - All Treated Participants



6.  Secondary:   The Number of Participants With Plasma HIV RNA Levels < 50 c/mL at Week 48 as Analyzed by Different Algorithms - All Treated Participants   [ Time Frame: Week 48 ]

Measure Type Secondary
Measure Title The Number of Participants With Plasma HIV RNA Levels < 50 c/mL at Week 48 as Analyzed by Different Algorithms - All Treated Participants
Measure Description Algorithms: Confirmed Virologic Response (CVR) non-completer = failure (NC = F): participants were responders if they achieved confirmed HIV RNA < 50 c/mL at Week 48; participants were failures if virologic rebound occurred at or before Week 48; therapy discontinued before Week 48; no response by Week 48, or missing HIV RNA at Week 48 and beyond. Virologic Response - Observed Cases (VR-OC): participants were responders according to a single on-treatment HIV RNA < 50 c/mL closest to the planned Week 48 visit and within the predefined Week 48 visit window; those on treatment and missing their Week 48 measurement were responders only if previous and subsequent measurements to the Week 48 visit window were < 50 c/mL; denominator was all who remained on treatment through Week 48. Snapshot: participants were responders according to the last on-treatment HIV RNA < 50 c/mL in the predefined Week 48 visit window; denominator was all treated participants.
Time Frame Week 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated participants, who received at least 1 dose of study drug (EFV), were analyzed. n=number of participants with available on-treatment data for analysis by each algorithm.

Reporting Groups
  Description
EFV+ddI+FTC in Infants >=3 Months to < 6 Months EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Infants >=6 Months to < 2 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Children >= 2 Years to < 3 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Children >= 3 Years to <= 6 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in All Participants All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.

Measured Values
    EFV+ddI+FTC in Infants >=3 Months to < 6 Months     EFV+ddI+FTC in Infants >=6 Months to < 2 Years     EFV+ddI+FTC in Children >= 2 Years to < 3 Years     EFV+ddI+FTC in Children >= 3 Years to <= 6 Years     EFV+ddI+FTC in All Participants  
Number of Participants Analyzed  
[units: participants]
  15     10     4     8     37  
The Number of Participants With Plasma HIV RNA Levels < 50 c/mL at Week 48 as Analyzed by Different Algorithms - All Treated Participants  
[units: participants]
         
CVR (NC=F) n=15, 10, 4, 8, 37     6     6     2     4     18  
VR-OC n=9, 9, 3, 6, 27     6     5     2     4     17  
SNAPSHOT n=15, 10, 4, 8, 37     6     5     2     4     17  

No statistical analysis provided for The Number of Participants With Plasma HIV RNA Levels < 50 c/mL at Week 48 as Analyzed by Different Algorithms - All Treated Participants



7.  Secondary:   The Number of Participants With Plasma HIV RNA Levels < 400 c/mL at Week 24 as Analyzed by Different Algorithms - All Treated Participants   [ Time Frame: Week 24 ]

Measure Type Secondary
Measure Title The Number of Participants With Plasma HIV RNA Levels < 400 c/mL at Week 24 as Analyzed by Different Algorithms - All Treated Participants
Measure Description Algorithms: Confirmed Virologic Response (CVR) non-completer = failure (NC = F): participants were responders if they achieved confirmed HIV RNA < 400 c/mL at Week 24; participants were failures if virologic rebound occurred at or before Week 24; therapy discontinued before Week 24; no response by Week 24, or missing HIV RNA at Week 24 and beyond. Virologic Response - Observed Cases (VR-OC): participants were responders according to a single on-treatment HIV RNA < 400 c/mL closest to the planned Week 24 visit and within the predefined Week 24 visit window; those on treatment and missing their Week 24 measurement were responders only if previous and subsequent measurements to the Week 24 visit window were < 400 c/mL; denominator was all who remained on treatment through Week 24.
Time Frame Week 24  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated participants, who received at least 1 dose of study drug (EFV), were analyzed. n=number of participants with available on-treatment data for analysis by each algorithm.

Reporting Groups
  Description
EFV+ddI+FTC in Infants >=3 Months to < 6 Months EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Infants >=6 Months to < 2 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Children >= 2 Years to < 3 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Children >= 3 Years to <= 6 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in All Participants All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.

Measured Values
    EFV+ddI+FTC in Infants >=3 Months to < 6 Months     EFV+ddI+FTC in Infants >=6 Months to < 2 Years     EFV+ddI+FTC in Children >= 2 Years to < 3 Years     EFV+ddI+FTC in Children >= 3 Years to <= 6 Years     EFV+ddI+FTC in All Participants  
Number of Participants Analyzed  
[units: participants]
  15     10     4     8     37  
The Number of Participants With Plasma HIV RNA Levels < 400 c/mL at Week 24 as Analyzed by Different Algorithms - All Treated Participants  
[units: participants]
         
CVR (n=15, 10, 4, 8, 37)     8     7     4     7     26  
VR-OC(n=11,10 ,4, 7, 32)     8     7     4     6     25  

No statistical analysis provided for The Number of Participants With Plasma HIV RNA Levels < 400 c/mL at Week 24 as Analyzed by Different Algorithms - All Treated Participants



8.  Secondary:   The Number of Participants With Plasma HIV RNA Levels < 50 c/mL at Week 24 as Analyzed by Different Algorithms - All Treated Participants   [ Time Frame: Week 24 ]

Measure Type Secondary
Measure Title The Number of Participants With Plasma HIV RNA Levels < 50 c/mL at Week 24 as Analyzed by Different Algorithms - All Treated Participants
Measure Description Algorithms: Confirmed Virologic Response (CVR) non-completer = failure (NC = F): participants were responders if they achieved confirmed HIV RNA < 50 c/mL at Week 24; participants were failures if virologic rebound occurred at or before Week 24; therapy discontinued before Week 24; no response by Week 24, or missing HIV RNA at Week 24 and beyond. Virologic Response - Observed Cases (VR-OC): participants were responders according to a single on-treatment HIV RNA < 50 c/mL closest to the planned Week 24 visit and within the predefined Week 24 visit window; those on treatment and missing their Week 24 measurement were responders only if previous and subsequent measurements to the Week 24 visit window were < 50 c/mL; denominator was all who remained on treatment through Week 24.
Time Frame Week 24  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated participants, who received at least 1 dose of study drug (EFV), were analyzed. n=number of participants with available on-treatment data for analysis by each algorithm.

Reporting Groups
  Description
EFV+ddI+FTC in Infants >=3 Months to < 6 Months EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Infants >=6 Months to < 2 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Children >= 2 Years to < 3 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Children >= 3 Years to <= 6 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in All Participants All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.

Measured Values
    EFV+ddI+FTC in Infants >=3 Months to < 6 Months     EFV+ddI+FTC in Infants >=6 Months to < 2 Years     EFV+ddI+FTC in Children >= 2 Years to < 3 Years     EFV+ddI+FTC in Children >= 3 Years to <= 6 Years     EFV+ddI+FTC in All Participants  
Number of Participants Analyzed  
[units: participants]
  15     10     4     8     37  
The Number of Participants With Plasma HIV RNA Levels < 50 c/mL at Week 24 as Analyzed by Different Algorithms - All Treated Participants  
[units: participants]
         
CVR (n=15, 10, 4, 8, 37)     4     4     3     4     15  
VR-OC (n=11, 10, 4, 7, 32)     5     5     2     4     16  

No statistical analysis provided for The Number of Participants With Plasma HIV RNA Levels < 50 c/mL at Week 24 as Analyzed by Different Algorithms - All Treated Participants



9.  Secondary:   Log10 c/mL HIV RNA Changes From Baseline Through Week 48 - Treated Participants   [ Time Frame: Baseline through Week 48 ]

Measure Type Secondary
Measure Title Log10 c/mL HIV RNA Changes From Baseline Through Week 48 - Treated Participants
Measure Description HIV RNA measured as log10 copies per milliliter (c/mL) plasma. HIV RNA values ≥ 1,000 c/mL were considered evidence of infection. A decrease in number of c/mL is an improvement for the participant. HIV RNA was first measured using the ultrasensitive and standard Roche Amplicor PCR, version 1.5, and then the method of measurement was switched to the COBAS AmpliPrep/COBAS TaqMan HIV IVD method. The Baseline visit was within 50 days after the screening visit and was prior to start of study medication (Week 1).
Time Frame Baseline through Week 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated participants who received at least 1 dose of study drug (EFV) and had an available baseline measurement were analyzed. n=number of participants with available data at both baseline and each specific week.

Reporting Groups
  Description
EFV+ddI+FTC in Infants >=3 Months to < 6 Months EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Infants >=6 Months to < 2 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Children >= 2 Years to < 3 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Children >= 3 Years to <= 6 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in All Participants All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.

Measured Values
    EFV+ddI+FTC in Infants >=3 Months to < 6 Months     EFV+ddI+FTC in Infants >=6 Months to < 2 Years     EFV+ddI+FTC in Children >= 2 Years to < 3 Years     EFV+ddI+FTC in Children >= 3 Years to <= 6 Years     EFV+ddI+FTC in All Participants  
Number of Participants Analyzed  
[units: participants]
  13     10     4     7     34  
Log10 c/mL HIV RNA Changes From Baseline Through Week 48 - Treated Participants  
[units: log10 c/mL]
Median ( Inter-Quartile Range )
         
Baseline (n=13,10,4,7,34)     5.88  
  ( 5.12 to 5.92 )  
  5.88  
  ( 5.32 to 5.88 )  
  5.88  
  ( 5.38 to 5.88 )  
  5.50  
  ( 4.64 to 5.88 )  
  5.88  
  ( 4.97 to 5.88 )  
Week 2 (n=12, 9, 4, 5, 30)     -1.89  
  ( -2.60 to -0.93 )  
  -2.26  
  ( -2.32 to -1.73 )  
  -2.42  
  ( -3.38 to -2.11 )  
  -1.93  
  ( -2.49 to -1.85 )  
  -2.11  
  ( -2.51 to -1.36 )  
Week 4 (n=11, 8, 4, 6, 29)     -2.18  
  ( -2.81 to -0.58 )  
  -2.49  
  ( -2.86 to -1.86 )  
  -2.86  
  ( -3.14 to -2.73 )  
  -3.04  
  ( -3.24 to -2.25 )  
  -2.63  
  ( -3.06 to -1.69 )  
Week 8 (n=11, 10, 3, 7, 31)     -2.73  
  ( -3.48 to -0.76 )  
  -2.91  
  ( -3.27 to -1.54 )  
  -2.92  
  ( -3.12 to -2.90 )  
  -3.27  
  ( -4.05 to -2.59 )  
  -2.92  
  ( -3.33 to -1.69 )  
Week 12 (n=10, 10, 3, 6, 29)     -2.48  
  ( -4.00 to -1.33 )  
  -3.19  
  ( -3.27 to -1.00 )  
  -4.02  
  ( -4.18 to -3.18 )  
  -3.31  
  ( -3.87 to -2.95 )  
  -3.14  
  ( -3.87 to -1.63 )  
Week 16 (n=10, 10, 4, 7, 31)     -2.72  
  ( -4.18 to -1.67 )  
  -3.17  
  ( -3.55 to -0.44 )  
  -4.11  
  ( -4.18 to -3.61 )  
  -3.44  
  ( -4.05 to -2.95 )  
  -3.27  
  ( -4.05 to -1.94 )  
Week 24 (n=10, 9, 3, 7, 29)     -3.46  
  ( -4.24 to -1.11 )  
  -3.92  
  ( -4.18 to -2.03 )  
  -4.18  
  ( -4.18 to -2.43 )  
  -2.95  
  ( -4.18 to -2.12 )  
  -3.28  
  ( -4.18 to -2.03 )  
Week 32 (n=9, 9, 4, 6, 28)     -2.75  
  ( -4.08 to -1.67 )  
  -3.28  
  ( -4.18 to -1.96 )  
  -3.73  
  ( -4.18 to -3.23 )  
  -2.93  
  ( -4.18 to -1.69 )  
  -3.27  
  ( -4.18 to -1.81 )  
Week 40 (n=7, 9, 4 ,6, 26)     -4.01  
  ( -4.24 to -1.94 )  
  -4.17  
  ( -4.18 to -3.28 )  
  -4.02  
  ( -4.18 to -3.52 )  
  -2.93  
  ( -4.18 to -0.87 )  
  -3.93  
  ( -4.18 to -2.90 )  
Week 48 (n=9, 9, 3, 6, 27)     -2.92  
  ( -4.18 to -1.67 )  
  -3.27  
  ( -4.18 to -1.95 )  
  -3.27  
  ( -4.18 to -3.18 )  
  -2.93  
  ( -4.18 to -1.69 )  
  -3.18  
  ( -4.18 to -1.69 )  

No statistical analysis provided for Log10 c/mL HIV RNA Changes From Baseline Through Week 48 - Treated Participants



10.  Secondary:   CD4 Cell Count Change From Baseline at Weeks 24 and 48 - Treated Participants   [ Time Frame: Baseline to Weeks 24 and 48 ]

Measure Type Secondary
Measure Title CD4 Cell Count Change From Baseline at Weeks 24 and 48 - Treated Participants
Measure Description A CD4 cell is an antigenic marker of helper/inducer T cells. These cells were counted during the hematology cell counts performed during a Complete Blood Cell count (CBC) performed by the Central Laboratory. CD4 are measured as number of cells per millimeters to the third power (cells/mm^3). An increase from baseline in the number of CD4 cells is an improvement. The Baseline visit was within 50 days after the screening visit and was prior to start of study medication (Week 1).
Time Frame Baseline to Weeks 24 and 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated participants who received at least 1 dose of study drug (EFV) and had an available baseline measurement were analyzed. n=number of participants with available data at both baseline and each specific week.

Reporting Groups
  Description
EFV+ddI+FTC in Infants >=3 Months to < 6 Months EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Infants >=6 Months to < 2 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Children >= 2 Years to < 3 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Children >= 3 Years to <= 6 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in All Participants All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.

Measured Values
    EFV+ddI+FTC in Infants >=3 Months to < 6 Months     EFV+ddI+FTC in Infants >=6 Months to < 2 Years     EFV+ddI+FTC in Children >= 2 Years to < 3 Years     EFV+ddI+FTC in Children >= 3 Years to <= 6 Years     EFV+ddI+FTC in All Participants  
Number of Participants Analyzed  
[units: participants]
  10     9     3     6     28  
CD4 Cell Count Change From Baseline at Weeks 24 and 48 - Treated Participants  
[units: cells/mm^3]
Median ( Inter-Quartile Range )
         
Baseline (n=10, 9, 3, 6, 28)     1518  
  ( 829 to 2202 )  
  1569  
  ( 1149 to 2284 )  
  517  
  ( 129 to 558 )  
  413  
  ( 23 to 688 )  
  1144  
  ( 529 to 1930 )  
Week 24 (n=6, 7, 3, 6, 22)     259  
  ( -180 to 840 )  
  82  
  ( -436 to 669 )  
  31  
  ( 15 to 2478 )  
  283  
  ( 146 to 452 )  
  177  
  ( 15 to 669 )  
Week 48 (n=7, 8, 2, 5, 22)     -258  
  ( -1313 to 606 )  
  346  
  ( -622 to 846 )  
  971  
  ( 15 to 1927 )  
  284  
  ( 215 to 330 )  
  196  
  ( -258 to 721 )  

No statistical analysis provided for CD4 Cell Count Change From Baseline at Weeks 24 and 48 - Treated Participants



11.  Secondary:   Percent of CD4 Cells Change From Baseline at Weeks 24 and 48 - Treated Participants   [ Time Frame: Baseline to Weeks 24 and 48 ]

Measure Type Secondary
Measure Title Percent of CD4 Cells Change From Baseline at Weeks 24 and 48 - Treated Participants
Measure Description A CD4 cell is an antigenic marker of helper/inducer T cells. These cells were counted during the hematology cell counts performed during a Complete Blood Cell count (CBC) performed by the Central Laboratory. CD4 are measured as number of cells per millimeter to the third power (cells/mm^3). Percent of CD4 cells is the number of CD4 cells per total number of cells measured*100. An increase in the percent of CD4 cells is an improvement. The Baseline visit was within 50 days after the screening visit and was prior to start of study medication (Week 1).
Time Frame Baseline to Weeks 24 and 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated participants who received at least 1 dose of study drug (EFV) and had an available baseline measurement were analyzed. n=number of participants with available data at both baseline and each specific week.

Reporting Groups
  Description
EFV+ddI+FTC in Infants >=3 Months to < 6 Months EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Infants >=6 Months to < 2 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Children >= 2 Years to < 3 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Children >= 3 Years to <= 6 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in All Participants All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.

Measured Values
    EFV+ddI+FTC in Infants >=3 Months to < 6 Months     EFV+ddI+FTC in Infants >=6 Months to < 2 Years     EFV+ddI+FTC in Children >= 2 Years to < 3 Years     EFV+ddI+FTC in Children >= 3 Years to <= 6 Years     EFV+ddI+FTC in All Participants  
Number of Participants Analyzed  
[units: participants]
  7     9     3     5     24  
Percent of CD4 Cells Change From Baseline at Weeks 24 and 48 - Treated Participants  
[units: percentage of CD4 cells]
Median ( Inter-Quartile Range )
         
Baseline (n=7, 9, 3, 5, 24)     28  
  ( 17 to 40 )  
  26  
  ( 25 to 28 )  
  12  
  ( 5 to 20 )  
  7  
  ( 2 to 23 )  
  24  
  ( 14 to 28 )  
Week 24 (n=3, 7, 3, 5, 18)     14  
  ( -19 to 19 )  
  2  
  ( 0 to 14 )  
  9  
  ( -1 to 9 )  
  10  
  ( 9 to 16 )  
  9  
  ( 0 to 14 )  
Week 48 (n=5, 8, 2, 5, 20)     5  
  ( -2 to 7 )  
  4  
  ( -4 to 11 )  
  8  
  ( -1 to 17 )  
  11  
  ( 9 to 12 )  
  6  
  ( -1 to 13 )  

No statistical analysis provided for Percent of CD4 Cells Change From Baseline at Weeks 24 and 48 - Treated Participants



12.  Secondary:   Number of Participants With On-Treatment Adverse Events (AEs), Related Adverse Events, Serious Adverse Events (SAEs), Death, Discontinuation Due to Adverse Events, and CDC Class C AIDS Events   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Number of Participants With On-Treatment Adverse Events (AEs), Related Adverse Events, Serious Adverse Events (SAEs), Death, Discontinuation Due to Adverse Events, and CDC Class C AIDS Events
Measure Description Center for Disease Control and Prevention (CDC) classification of Class C events used to define acquired immunodeficiency syndrome (AIDS): include pneumocystis pneumonia, pneumonia, pulmonary tuberculosis. AE=new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. AE Severity: Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling (Division of AIDs Table, published December 2004). Baseline=within 50 days post screening, prior to start of study drug. 2 categories for death presented (on-treatment and enrolled/not treated).
Time Frame Baseline to Week 96  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All categories except one analyzed treated participants, who received at least 1 dose of study drug (EFV). One category analyzed enrolled participants who were not treated and cannot be assigned to a group.

Reporting Groups
  Description
EFV+ddI+FTC in Infants >=3 Months to < 6 Months EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Infants >=6 Months to < 2 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Children >= 2 Years to < 3 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Children >= 3 Years to <= 6 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in All Participants All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.

Measured Values
    EFV+ddI+FTC in Infants >=3 Months to < 6 Months     EFV+ddI+FTC in Infants >=6 Months to < 2 Years     EFV+ddI+FTC in Children >= 2 Years to < 3 Years     EFV+ddI+FTC in Children >= 3 Years to <= 6 Years     EFV+ddI+FTC in All Participants  
Number of Participants Analyzed  
[units: participants]
  15     10     4     8     37  
Number of Participants With On-Treatment Adverse Events (AEs), Related Adverse Events, Serious Adverse Events (SAEs), Death, Discontinuation Due to Adverse Events, and CDC Class C AIDS Events  
[units: participants]
         
Death (Treated Participants)     1     0     1     0     2  
Deaths (Enrolled Participants, Not treated)     2     0     0     0     2  
SAE (Treated Participants)     8     5     4     3     20  
AE (All Grades,Treated Participants)     13     9     4     6     32  
Grade 2 - 4 AEs (Treated Participants)     11     7     4     5     27  
Grade 3 - 4 AEs (Treated Participants)     4     2     3     1     10  
Related AE (All Grades,Treated Participants)     8     5     4     4     21  
Discontinued due to AE (Treated Participants)     2     0     0     0     2  
CDC Class C AIDS event (Treated Participants)     1     1     0     0     2  

No statistical analysis provided for Number of Participants With On-Treatment Adverse Events (AEs), Related Adverse Events, Serious Adverse Events (SAEs), Death, Discontinuation Due to Adverse Events, and CDC Class C AIDS Events



13.  Secondary:   Number of Participants With Liver Function Test Laboratory Abnormalities - Treated Population   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Number of Participants With Liver Function Test Laboratory Abnormalities - Treated Population
Measure Description Abnormalities were determined from laboratory measurements analyzed at the central or local laboratory. Division of AIDS Table (DAIDS) for Grading Severity of Adult and Pediatric AEs version (v) Dec 2004. Upper limit of normal (ULN): lower limit of normal (LLN), alanine transaminase (ALT); aspartate aminotransferase (AST); alkaline phosphatase (ALP). ALT Grade (Gr) 1: 1.25 to 2.5*ULN; Gr 2: 2.6 to 5.0*ULN; Gr 3: 5.1 to 10.0*ULN; Gr 4: >10.0*ULN. AST Gr 1: 1.25 to 2.5*ULN; Gr 2: 2.6 to 5.0*ULN; Gr 3: 5.1 to 10.0*ULN; Gr 4: >10.0*ULN. Total bilirubin Gr 1: 1.25 to 1.5*ULN; Gr 2: 1.6 to 2.5*ULN; Gr 3: 2.6 to 5.0*ULN; Gr 4: >5.0*ULN. ALP (U/L) Gr 1: 1.25 to 2.5*ULN, Gr 2: 2.6 to 5.0*ULN, Gr 3: 5.1 to 10.0*ULN, Gr 4: >10.0*ULN. Albumin (low) Gr 1: 3 grams per deciliter (g/dL) to <LLN ; Gr 2: 2.0-2.9 g/dL; Gr 3: < 2 g/dL. Gr 4: Not applicable. Baseline visit was within 50 days after the screening visit and was prior to start of study medication (Week 1).
Time Frame Baseline to Week 96  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated participants, who received at least 1 dose of study drug (EFV) were analyzed. n=number of treated participants with available on-treatment data (laboratory measurements).

Reporting Groups
  Description
EFV+ddI+FTC in Infants >=3 Months to < 6 Months EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Infants >=6 Months to < 2 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Children >= 2 Years to < 3 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Children >= 3 Years to <= 6 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in All Participants All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.

Measured Values
    EFV+ddI+FTC in Infants >=3 Months to < 6 Months     EFV+ddI+FTC in Infants >=6 Months to < 2 Years     EFV+ddI+FTC in Children >= 2 Years to < 3 Years     EFV+ddI+FTC in Children >= 3 Years to <= 6 Years     EFV+ddI+FTC in All Participants  
Number of Participants Analyzed  
[units: participants]
  15     10     4     8     37  
Number of Participants With Liver Function Test Laboratory Abnormalities - Treated Population  
[units: participants]
         
Albumin (n=12, 10, 4, 7, 33)     0     0     1     0     1  
ALP (n=12, 10, 4, 7, 33)     8     2     2     5     17  
ALT (n=12, 10, 4, 7, 33)     7     3     2     0     12  
AST (n=12, 10, 4, 7, 33)     8     1     1     0     10  

No statistical analysis provided for Number of Participants With Liver Function Test Laboratory Abnormalities - Treated Population



14.  Secondary:   Number of Participants With Lipid and Glucose Laboratory Abnormalities - Treated Participants   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Number of Participants With Lipid and Glucose Laboratory Abnormalities - Treated Participants
Measure Description Abnormalities were determined from measurements analyzed at central or local laboratory. DAIDS Grading Severity of Adult and Pediatric AEs v Dec 2004. Total Cholesterol (fasting) Gr 1: 170 - 199 mg/dL; Gr 2: 200 - 300 mg/dL; Gr 3 >300 mg/dL; Gr 4 Not Applicable(NA). LDL cholesterol, fasting: Gr 1: 110-129 mg/dL; Gr 2: 130-189 mg/dL; Gr 3 >=190 mg/dL; Gr 4 NA. Triglycerides, fasting: Gr 1: NA; Gr 2 500-750 mg/dL; Gr 3: 751-1,200 mg/dL; Gr 4: >1,200 mg/dL. Glucose, serum, high, fasting and (non-fasting): Gr 1: 110 - 125 (116-160) mg/dL; Gr 2: 126-250 (161- 250) mg/dL; Gr 3: 251-500 (251-500) mg/dL; Gr 4: >500 (> 500) mg/dL. Glucose, serum, low, >=1 month of age (<1 month): Gr 1: 55-64 (50-54) mg/dL; Gr 2: 40-54 (40-49) mg/dL; Gr 3: 30-39 (30-39) mg/dL; Gr 4: <30 (<30) mg/dL. Baseline: within 50 days after the screening visit and was prior to start of study medication (Week 1). Only those in 4th arm were old enough to fast prior to testing; other arms did not have fasting samples taken.
Time Frame Baseline to Week 96  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated participants, who received at least 1 dose of study drug (EFV) were analyzed. n=number of treated participants with available on-treatment data (laboratory measurements).

Reporting Groups
  Description
EFV+ddI+FTC in Infants >=3 Months to < 6 Months EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Infants >=6 Months to < 2 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Children >= 2 Years to < 3 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Children >= 3 Years to <= 6 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in All Participants All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.

Measured Values
    EFV+ddI+FTC in Infants >=3 Months to < 6 Months     EFV+ddI+FTC in Infants >=6 Months to < 2 Years     EFV+ddI+FTC in Children >= 2 Years to < 3 Years     EFV+ddI+FTC in Children >= 3 Years to <= 6 Years     EFV+ddI+FTC in All Participants  
Number of Participants Analyzed  
[units: participants]
  15     10     4     8     37  
Number of Participants With Lipid and Glucose Laboratory Abnormalities - Treated Participants  
[units: participants]
         
Total Cholesterol (n=9,10,4,0,23)     2     4     1     NA [1]   7  
Total Cholesterol Fasting (n=0,0,0,7,7)     NA [2]   NA [2]   NA [2]   1     1  
Glucose High (n=11,10,3,0,24)     1     0     0     NA [1]   1  
Glucose Low (n=11,10,3,0,24)     2     1     0     NA [1]   3  
Glucose High Fasting (n=0,0,0,7,7)     NA [2]   NA [2]   NA [2]   1     1  
LDL cholesterol (n=9,10,4,0,23)     0     4     0     NA [1]   4  
LDL cholesterol fasting (n=0,0,0,7,7)     NA [2]   NA [2]   NA [2]   1     1  
[1] only fasting samples taken
[2] too young to fast, samples not taken

No statistical analysis provided for Number of Participants With Lipid and Glucose Laboratory Abnormalities - Treated Participants



15.  Secondary:   Number of Participants With Serum Chemistry Abnormalities - Treated Participants   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Number of Participants With Serum Chemistry Abnormalities - Treated Participants
Measure Description Central/local laboratory. DAIDS v 2004. Bicarbonate, low: Gr 1: 16 milliequivalents per liter (mEq/L) - < LLN; Gr 2: 11.0-15.9 mEq/L; Gr 3: 8.0-10.9 mEq/L; Gr 4: <8.0 mEq/L; calcium, high Gr 1: 10.6-11.5 mg/dL; Gr 2: 11.6-12.5 mg/dL; Gr 3 12.6-13.5 mg/dL; Gr 4: >13.5 mg/dL; calcium, low Gr1: 7.8-8.4 mg/dL; Gr2: 7.0-7.7 mg/dL; Gr3: 6.1-6.9 mg/dL; Gr 4: <6.1 mg/dL; creatinine Gr1: 1.1-1.3*ULN; Gr 2: 1.4-1.8*ULN; Gr 3: 1.9-3.4*ULN; Gr 4: >=3.5*ULN; lipase Gr 1: 1.1-1.5*ULN; Gr 2: 1.6-3.0*ULN; Gr 3: 3.1-5.0*ULN; Gr 4: >5.0*ULN; potassium high (low) Gr 1: 5.6-6.0 (3.0-3.4) mEq/L; Gr 2: 6.1-6.5 (2.5-2.9) mEq/L; Gr 3: 6.6-7.0 (2.0-2.4) mEq/L; Gr 4: >7.0 (<2.0) mEq/L; sodium, high (low) Gr 1: 146-150 (130-135) mEq/L; Gr 2: 151-154 (125-129) mEq/L; Gr 3: 155-159 (121-124) mEq/L; Gr 4: >=160 (<=120) mEq/L; uric acid Gr 1: 7.5-10.0 mg/dL; Gr 2: 10.1-12.0 mg/dL; Gr 3: 12.1-15.0 mg/dL; Gr 4: >15.0 mg/dL. Baseline within 50 days post screening, prior to start of study medication.
Time Frame Baseline to Week 96  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated participants, who received at least 1 dose of study drug (EFV) were analyzed. n=number of treated participants with available on-treatment data (laboratory measurements).

Reporting Groups
  Description
EFV+ddI+FTC in Infants >=3 Months to < 6 Months EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Infants >=6 Months to < 2 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Children >= 2 Years to < 3 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Children >= 3 Years to <= 6 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in All Participants All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.

Measured Values
    EFV+ddI+FTC in Infants >=3 Months to < 6 Months     EFV+ddI+FTC in Infants >=6 Months to < 2 Years     EFV+ddI+FTC in Children >= 2 Years to < 3 Years     EFV+ddI+FTC in Children >= 3 Years to <= 6 Years     EFV+ddI+FTC in All Participants  
Number of Participants Analyzed  
[units: participants]
  15     10     4     8     37  
Number of Participants With Serum Chemistry Abnormalities - Treated Participants  
[units: participants]
         
Bicarbonate, low (n=12, 10, 4, 7, 33)     10     9     4     5     28  
Sodium, low (n=12, 10, 4, 7, 33)     5     4     2     4     15  
Sodium High (n=12, 10, 4, 7, 33)     1     1     0     1     3  
Uric Acid (n=12, 10, 4, 7, 33)     0     1     1     0     2  
Calcium High (n= 12, 10, 4, 7, 33)     0     2     0     1     3  
Calcium Low (n= 12, 10, 4, 7, 33)     0     4     1     1     6  
Potassium High (n= 12, 10, 4, 7, 33)     5     4     0     0     9  
Potassium Low (n= 12, 10, 4, 7, 33)     1     0     1     1     3  
Lipase Total (n= 12, 10, 4, 7, 33)     1     0     0     2     3  

No statistical analysis provided for Number of Participants With Serum Chemistry Abnormalities - Treated Participants



16.  Secondary:   Number of Participants With Hematologic Abnormalities - Treated Participants   [ Time Frame: Baseline to Week 96 ]

Measure Type Secondary
Measure Title Number of Participants With Hematologic Abnormalities - Treated Participants
Measure Description Abnormalities were determined from laboratory measurements analyzed at the central or local laboratory. DAIDS DAIDS Grading Severity of Adult and Pediatric AEs v Dec 2004. Hemoglobin Gr 1: 8.5-10.0 g/dL; Gr 2: 7.5-8.4 g/dL; Gr 3: 6.50-7.4 g/dL; Gr 4: <6.5 g/dL; Platelets, decreased: Gr 1: 100.000-124.999*10^9/L; Gr 2: 50.000-99.999*10^9/L; Gr 3: 25.000-49.999*10^9/L; Gr 4: <25.000*10^9/L; White blood cell count (WBC) decreased Gr 1: 2.000-2.500*10^9/L; Gr 2: 1.500-1.999*10^9/L; Gr 3: 1.000-1.499*10^9/L; Gr 4: <1.000*10^9/L. Baseline visit was within 50 days post screening and was prior to start of study drug (Week 1).
Time Frame Baseline to Week 96  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated participants, who received at least 1 dose of study drug (EFV) were analyzed. n=number of treated participants with available on-treatment data (laboratory measurements).

Reporting Groups
  Description
EFV+ddI+FTC in Infants >=3 Months to < 6 Months EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Infants >=6 Months to < 2 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Children >= 2 Years to < 3 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Children >= 3 Years to <= 6 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in All Participants All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.

Measured Values
    EFV+ddI+FTC in Infants >=3 Months to < 6 Months     EFV+ddI+FTC in Infants >=6 Months to < 2 Years     EFV+ddI+FTC in Children >= 2 Years to < 3 Years     EFV+ddI+FTC in Children >= 3 Years to <= 6 Years     EFV+ddI+FTC in All Participants  
Number of Participants Analyzed  
[units: participants]
  15     10     4     8     37  
Number of Participants With Hematologic Abnormalities - Treated Participants  
[units: participants]
         
Hemoglobin (n=11, 10, 4, 7, 32)     4     5     2     1     12  
Platelet (n=11, 10, 4, 7, 32)     1     1     0     0     2  
Neutrophils (n=11, 10, 4, 7, 32)     7     2     0     1     10  

No statistical analysis provided for Number of Participants With Hematologic Abnormalities - Treated Participants



17.  Secondary:   Number of Treated Participants With Resistance Associated Genotypic and Phenotypic Changes in Viruses - Participants With Virologic Failure, Lack of Suppression or Viral Load Rebound   [ Time Frame: Baseline to Week 48 ]

Measure Type Secondary
Measure Title Number of Treated Participants With Resistance Associated Genotypic and Phenotypic Changes in Viruses - Participants With Virologic Failure, Lack of Suppression or Viral Load Rebound
Measure Description At baseline, treatment-naïve screened by genotype; treatment-experienced screened by genotype and phenotype. Genotypic resistance: presence of substitutions in reverse transcriptase (RT) gene and/or presence of mutations that confer resistance to nucleoside reverse transcriptase inhibitor class. Phenotype resistance: FTC: > 3.1* the 50% inhibitory concentration (IC50) of the control strain; EFV: > 3.3* IC50 ; ddI: > 2.6*IC50. Virologic failure: <1 log10 decrease in HIV RNA from Week 16 on; confirmatory HIV RNA within 14-35 days; HIV RNA > 10,000 c/mL with prior value < 400 c/mL; confirmatory HIV RNA 14-35 days. Monogram Biosciences Phenosense™ assay ( EFV and FTC: biologic cutoffs=3 and 3.5, respectively; ddI: clinical cutoff: lower limit=1.39; upper limit = 2.2.); VircoTYPE™ HIV-1 v 4.3.01( EFV, FTC: biologic cutoffs=3.3 and 3.1, respectively;ddI: clinical cutoff: lower limit = 0.9; upper limit = 2.6. No genotypic/phenotypic changes in presence of virologic failure=no resistance.
Time Frame Baseline to Week 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who met the definition of virologic failure per protocol (PP): n=6 ; in addition, those who rebounded on treatment with plasma HIV RNA > 10,000 c/mL but samples were not obtained within specified 35 day limit were included (not PP): n=5; participants with virologic failure and with samples available for analysis of virus changes:n=11.

Reporting Groups
  Description
EFV+ddI+FTC in Infants >=3 Months to < 6 Months EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Infants >=6 Months to < 2 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Children >= 2 Years to < 3 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Children >= 3 Years to <= 6 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in All Participants All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.

Measured Values
    EFV+ddI+FTC in Infants >=3 Months to < 6 Months     EFV+ddI+FTC in Infants >=6 Months to < 2 Years     EFV+ddI+FTC in Children >= 2 Years to < 3 Years     EFV+ddI+FTC in Children >= 3 Years to <= 6 Years     EFV+ddI+FTC in All Participants  
Number of Participants Analyzed  
[units: participants]
  4     5     1     1     11  
Number of Treated Participants With Resistance Associated Genotypic and Phenotypic Changes in Viruses - Participants With Virologic Failure, Lack of Suppression or Viral Load Rebound  
[units: participants]
         
Lack of suppression with Changes (PP)     2     1     0     0     3  
Viral Load Rebound with Changes(PP)     1     1     0     0     2  
Viral Failure with Changes (outside 35 day limit)     0     3     1     1     5  

No statistical analysis provided for Number of Treated Participants With Resistance Associated Genotypic and Phenotypic Changes in Viruses - Participants With Virologic Failure, Lack of Suppression or Viral Load Rebound



18.  Secondary:   Number of Participants With Acquisition of Resistance to EFV Categorized by AUC Relationship - Evaluable Pharmacokinetic Population   [ Time Frame: Baseline to Week 48 ]

Measure Type Secondary
Measure Title Number of Participants With Acquisition of Resistance to EFV Categorized by AUC Relationship - Evaluable Pharmacokinetic Population
Measure Description PK parameters were evaluated 2 weeks post start of dosing. Based on observed AUC, measured in micromoles (μM)*h, dosing was increased, remained the same, or decreased at next visit to achieve the desired AUC (110-380 μM*h). Number of participants who became resistant was categorized by those who required additional dosing after Week 2 (AUC<110 μM*h) and those who did not. AUC: derived from plasma concentration of EFV versus time. Plasma concentrations for determination of AUC were obtained using a validated LC-MS/MS method. LLOQ for EFV = 10.0 ng/mL and ULOQ = 8,000 ng/mL. AUC calculated by log- and linear trapezoidal summations. Genotypic resistance=presence of substitutions in the RT gene and/or presence of mutations that confer resistance to entire nucleoside reverse transcriptase inhibitor class. Phenotypic resistance=EFV: > 3.3* IC50 of control strain. Assays: Monogram Biosciences Phenosense™ GT (EFV biologic cutoff=3) and VircoTYPE™ HIV-1 v 4.3.01( EFV biologic cutoff=3.3).
Time Frame Baseline to Week 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who received at least one dose of study drug (EFV) and had adequate pharmacokinetic (PK) profiles at Week 2 were analyzed. n=number of participants with AUC<110 µM•h and number of participants with AUC>=110 µM•h.

Reporting Groups
  Description
EFV+ddI+FTC in Infants >=3 Months to < 6 Months EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Infants >=6 Months to < 2 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Children >= 2 Years to < 3 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Children >= 3 Years to <= 6 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in All Participants All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.

Measured Values
    EFV+ddI+FTC in Infants >=3 Months to < 6 Months     EFV+ddI+FTC in Infants >=6 Months to < 2 Years     EFV+ddI+FTC in Children >= 2 Years to < 3 Years     EFV+ddI+FTC in Children >= 3 Years to <= 6 Years     EFV+ddI+FTC in All Participants  
Number of Participants Analyzed  
[units: participants]
  12     10     4     7     33  
Number of Participants With Acquisition of Resistance to EFV Categorized by AUC Relationship - Evaluable Pharmacokinetic Population  
[units: participants]
         
Resistant; AUC<110 µM•h(n=2,7,2,3,14)     1     3     1     1     6  
Resistant; AUC>=110 µM•h(n=10,3,2,4,19)     2     2     0     0     4  

No statistical analysis provided for Number of Participants With Acquisition of Resistance to EFV Categorized by AUC Relationship - Evaluable Pharmacokinetic Population



19.  Secondary:   Cmax and Cmin of Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population   [ Time Frame: Week 2 ]

Measure Type Secondary
Measure Title Cmax and Cmin of Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population
Measure Description Cmax and Cmin were derived from plasma concentration versus time. Plasma concentrations for ddI were determined using a validated LC/MS/MS assay. All reportable Cmin values were <LLOQ in all age groups except >=6 months to < 2 years (Group 2); LLOQ/2 was imputed for those summary statistics;in Group 2, 9 of 10 Cmin values were <LLOQ; LLOQ/2 was imputed for those samples for summary statistics. The lower limit of quantification (LLOQ) for ddI was 2.50 nanograms per milliliter (ng/mL). Cmax and Cmin were recorded directly from experimental observations. Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters were summarized using geometric means. Cmax and Cmin were measured in ng/mL.
Time Frame Week 2  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who received at least one dose of study drug (EFV) and had adequate pharmacokinetic (PK) profiles were analyzed.

Reporting Groups
  Description
EFV+ddI+FTC in Infants >=3 Months to < 6 Months EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Infants >=6 Months to < 2 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Children >= 2 Years to < 3 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Children >= 3 Years to <= 6 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.

Measured Values
    EFV+ddI+FTC in Infants >=3 Months to < 6 Months     EFV+ddI+FTC in Infants >=6 Months to < 2 Years     EFV+ddI+FTC in Children >= 2 Years to < 3 Years     EFV+ddI+FTC in Children >= 3 Years to <= 6 Years  
Number of Participants Analyzed  
[units: participants]
  12     10     4     6  
Cmax and Cmin of Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population  
[units: ng/mL]
Geometric Mean ( Geometric Coefficient of Variation )
       
Cmax (n=12, 10, 4, 6)     850  
  ( 48% )  
  1193  
  ( 39% )  
  356  
  ( 69% )  
  376  
  ( 93% )  
Cmin (n=4, 10, 4, 3)     1.25  
  ( 0% )  
  1.54  
  ( 132% )  
  1.25  
  ( 0% )  
  1.25  
  ( 0% )  

No statistical analysis provided for Cmax and Cmin of Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population



20.  Secondary:   AUC (TAU) of Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population   [ Time Frame: Week 2 ]

Measure Type Secondary
Measure Title AUC (TAU) of Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population
Measure Description Plasma concentrations were obtained using a validated LC-MS/MS at Week 2. The lower limit of quantification (LLOQ) for ddI was 2.50 nanograms per milliliter (ng/mL). AUC(TAU) was calculated by log- and linear trapezoidal summations. If a concentration was < LLOQ at time TAU, the value of the concentration at time TAU was estimated using the quotient of the last quantifiable concentration and λ. Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters summarized using geometric means. AUC(TAU) was measured in nanograms*time per milliliter (ng•h/mL).
Time Frame Week 2  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who received at least one dose of study drug (EFV) and had adequate pharmacokinetic (PK) profiles were analyzed.

Reporting Groups
  Description
EFV+ddI+FTC in Infants >=3 Months to < 6 Months EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Infants >=6 Months to < 2 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Children >= 2 Years to < 3 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Children >= 3 Years to <= 6 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.

Measured Values
    EFV+ddI+FTC in Infants >=3 Months to < 6 Months     EFV+ddI+FTC in Infants >=6 Months to < 2 Years     EFV+ddI+FTC in Children >= 2 Years to < 3 Years     EFV+ddI+FTC in Children >= 3 Years to <= 6 Years  
Number of Participants Analyzed  
[units: participants]
  4     10     4     4  
AUC (TAU) of Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population  
[units: ng•h/mL]
Geometric Mean ( Geometric Coefficient of Variation )
  1445  
  ( 76% )  
  2848  
  ( 53% )  
  1038  
  ( 54% )  
  1000  
  ( 41% )  

No statistical analysis provided for AUC (TAU) of Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population



21.  Secondary:   CLT/F of Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population   [ Time Frame: Week 2 ]

Measure Type Secondary
Measure Title CLT/F of Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population
Measure Description Plasma concentrations for ddI were determined using a validated LC/MS/MS assay. The LLOQ for ddI was 2.50 nanograms per milliliter (ng/mL). CLT/F was calculated by dividing the dose of ddI by AUC(TAU) of ddI. Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters were summarized using geometric means. CLT/F was measured in liters per hour (L/h).
Time Frame Week 2  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who received at least one dose of study drug (EFV) and had adequate pharmacokinetic (PK) profiles were analyzed.

Reporting Groups
  Description
EFV+ddI+FTC in Infants >=3 Months to < 6 Months EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Infants >=6 Months to < 2 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Children >= 2 Years to < 3 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Children >= 3 Years to <= 6 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.

Measured Values
    EFV+ddI+FTC in Infants >=3 Months to < 6 Months     EFV+ddI+FTC in Infants >=6 Months to < 2 Years     EFV+ddI+FTC in Children >= 2 Years to < 3 Years     EFV+ddI+FTC in Children >= 3 Years to <= 6 Years  
Number of Participants Analyzed  
[units: participants]
  4     10     4     4  
CLT/F of Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population  
[units: L/h]
Geometric Mean ( Geometric Coefficient of Variation )
  40.7  
  ( 110% )  
  35.6  
  ( 42% )  
  113.9  
  ( 111% )  
  143.0  
  ( 53% )  

No statistical analysis provided for CLT/F of Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population



22.  Secondary:   CLT/F/kg of Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population   [ Time Frame: Week 2 ]

Measure Type Secondary
Measure Title CLT/F/kg of Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population
Measure Description Plasma concentrations for ddI were determined using a validated LC/MS/MS assay. The LLOQ for ddI was 2.50 nanograms per milliliter (ng/mL). CLT/F/kg was calculated by dividing CLT/F by body weight in kilograms (kg). Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters were summarized using geometric means. CLT/F/kg was measured in liters per hour per kilogram (L/h/kg).
Time Frame Week 2  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who received at least one dose of study drug (EFV) and had adequate pharmacokinetic (PK) profiles were analyzed.

Reporting Groups
  Description
EFV+ddI+FTC in Infants >=3 Months to < 6 Months EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Infants >=6 Months to < 2 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Children >= 2 Years to < 3 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Children >= 3 Years to <= 6 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.

Measured Values
    EFV+ddI+FTC in Infants >=3 Months to < 6 Months     EFV+ddI+FTC in Infants >=6 Months to < 2 Years     EFV+ddI+FTC in Children >= 2 Years to < 3 Years     EFV+ddI+FTC in Children >= 3 Years to <= 6 Years  
Number of Participants Analyzed  
[units: participants]
  4     10     4     4  
CLT/F/kg of Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population  
[units: L/h/kg]
Geometric Mean ( Geometric Coefficient of Variation )
  7.88  
  ( 85% )  
  4.26  
  ( 30% )  
  11.36  
  ( 116% )  
  10.34  
  ( 70% )  

No statistical analysis provided for CLT/F/kg of Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population



23.  Secondary:   Terminal Phase Elimination Half-life (T-HALF) in Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population   [ Time Frame: Week 2 ]

Measure Type Secondary
Measure Title Terminal Phase Elimination Half-life (T-HALF) in Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population
Measure Description Plasma concentrations for ddI were determined using a validated LC/MS/MS assay. The LLOQ for ddI was 2.50 nanograms per milliliter (ng/mL). Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the T-HALF was summarized using a mean. Terminal elimination plasma half-life=ln2 divided by K where K is the absolute value of the slope of the terminal phase of the plasma profile as determined by log-linear regression of at least three data points. T-HALF was measured in hours (h).
Time Frame Week 2  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who received at least one dose of study drug (EFV) and had adequate pharmacokinetic (PK) profiles were analyzed.

Reporting Groups
  Description
EFV+ddI+FTC in Infants >=3 Months to < 6 Months EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Infants >=6 Months to < 2 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Children >= 2 Years to < 3 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Children >= 3 Years to <= 6 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.

Measured Values
    EFV+ddI+FTC in Infants >=3 Months to < 6 Months     EFV+ddI+FTC in Infants >=6 Months to < 2 Years     EFV+ddI+FTC in Children >= 2 Years to < 3 Years     EFV+ddI+FTC in Children >= 3 Years to <= 6 Years  
Number of Participants Analyzed  
[units: participants]
  3     10     4     4  
Terminal Phase Elimination Half-life (T-HALF) in Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population  
[units: h]
Mean ± Standard Deviation
  0.92  ± 0.1374     1.41  ± 0.859     1.73  ± 1.007     1.14  ± 0.214  

No statistical analysis provided for Terminal Phase Elimination Half-life (T-HALF) in Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population



24.  Secondary:   The Number of Participants With Plasma HIV RNA Levels < 400 c/mL at Weeks 60, 72, 84 and 96 (Observed Cases) – All Treated Participants   [ Time Frame: Weeks 60, 72, 84, and 96 ]

Measure Type Secondary
Measure Title The Number of Participants With Plasma HIV RNA Levels < 400 c/mL at Weeks 60, 72, 84 and 96 (Observed Cases) – All Treated Participants
Measure Description Virologic Response - Observed Cases (VR-OC): participants were responders at a specific week according to a single on-treatment HIV RNA < 400 c/mL closest to the planned visit and within the predefined visit window; those on treatment and missing their specific week measurement were responders only if previous and subsequent measurements to that week visit window were < 400 c/mL; denominator was all who remained on treatment through the specific week.
Time Frame Weeks 60, 72, 84, and 96  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated participants, who received at least 1 dose of study drug (EFV) were analyzed. n=number of treated participants with available on-treatment data at each specific week.

Reporting Groups
  Description
EFV+ddI+FTC in Infants >=3 Months to < 6 Months EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Infants >=6 Months to < 2 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Children >= 2 Years to < 3 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Children >= 3 Years to <= 6 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in All Participants All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.

Measured Values
    EFV+ddI+FTC in Infants >=3 Months to < 6 Months     EFV+ddI+FTC in Infants >=6 Months to < 2 Years     EFV+ddI+FTC in Children >= 2 Years to < 3 Years     EFV+ddI+FTC in Children >= 3 Years to <= 6 Years     EFV+ddI+FTC in All Participants  
Number of Participants Analyzed  
[units: participants]
  15     10     4     8     37  
The Number of Participants With Plasma HIV RNA Levels < 400 c/mL at Weeks 60, 72, 84 and 96 (Observed Cases) – All Treated Participants  
[units: participants]
         
Week 60 (n=7, 8, 3, 4, 22)     7     6     2     4     19  
Week 72 (n=7, 7, 2, 4, 20)     7     5     1     4     17  
Week 84 (n=7, 7, 2, 4, 20)     7     5     1     4     17  
Week 96 (n=7, 6, 2, 4, 19)     7     5     1     4     17  

No statistical analysis provided for The Number of Participants With Plasma HIV RNA Levels < 400 c/mL at Weeks 60, 72, 84 and 96 (Observed Cases) – All Treated Participants



25.  Secondary:   The Number of Participants With Plasma HIV RNA Levels < 50 c/mL at Weeks 60, 72, 84 and 96 (Observed Cases) – All Treated Participants   [ Time Frame: Weeks 60, 72, 84, and 96 ]

Measure Type Secondary
Measure Title The Number of Participants With Plasma HIV RNA Levels < 50 c/mL at Weeks 60, 72, 84 and 96 (Observed Cases) – All Treated Participants
Measure Description Virologic Response - Observed Cases (VR-OC): participants were responders at a specific week according to a single on-treatment HIV RNA < 50 c/mL closest to the planned visit and within the predefined visit window; those on treatment and missing their specific week measurement were responders only if previous and subsequent measurements to that week visit window were < 50 c/mL; denominator was all who remained on treatment through the specific week.
Time Frame Weeks 60, 72, 84, and 96  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated participants, who received at least 1 dose of study drug (EFV) were analyzed. n=number of treated participants with available on-treatment data at each specific week.

Reporting Groups
  Description
EFV+ddI+FTC in Infants >=3 Months to < 6 Months EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Infants >=6 Months to < 2 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Children >= 2 Years to < 3 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Children >= 3 Years to <= 6 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in All Participants All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.

Measured Values
    EFV+ddI+FTC in Infants >=3 Months to < 6 Months     EFV+ddI+FTC in Infants >=6 Months to < 2 Years     EFV+ddI+FTC in Children >= 2 Years to < 3 Years     EFV+ddI+FTC in Children >= 3 Years to <= 6 Years     EFV+ddI+FTC in All Participants  
Number of Participants Analyzed  
[units: participants]
  15     10     4     8     37  
The Number of Participants With Plasma HIV RNA Levels < 50 c/mL at Weeks 60, 72, 84 and 96 (Observed Cases) – All Treated Participants  
[units: participants]
         
Week 60 (n=7, 8, 3, 4, 22)     4     5     2     3     14  
Week 72 (n=7, 7, 2, 4, 20)     7     5     1     4     17  
Week 84 (n=7, 7, 2, 4, 20)     7     5     1     3     16  
Week 96 (n=7, 6, 2, 4, 19)     6     5     0     4     15  

No statistical analysis provided for The Number of Participants With Plasma HIV RNA Levels < 50 c/mL at Weeks 60, 72, 84 and 96 (Observed Cases) – All Treated Participants



26.  Secondary:   Log10 c/mL HIV RNA Changes From Baseline at Weeks 60, 72, 84 and 96 - Treated Participants   [ Time Frame: Baseline through Weeks 60, 72, 84, and 96 ]

Measure Type Secondary
Measure Title Log10 c/mL HIV RNA Changes From Baseline at Weeks 60, 72, 84 and 96 - Treated Participants
Measure Description HIV RNA measured as log10 copies per milliliter (c/mL) plasma. HIV RNA values ≥ 1,000 c/mL were considered evidence of infection. A decrease in number of c/mL is an improvement for the participant. HIV RNA was first measured using the ultrasensitive and standard Roche Amplicor PCR, version 1.5, and then the method of measurement was switched to the COBAS AmpliPrep/COBAS TaqMan HIV IVD method. The Baseline visit was within 50 days after the screening visit and was prior to start of study medication (Week 1).
Time Frame Baseline through Weeks 60, 72, 84, and 96  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated participants who received at least 1 dose of study drug (EFV) were analyzed. n=number of participants with available data at both baseline and each specific week on treatment.

Reporting Groups
  Description
EFV+ddI+FTC in Infants >=3 Months to < 6 Months EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Infants >=6 Months to < 2 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Children >= 2 Years to < 3 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Children >= 3 Years to <= 6 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in All Participants All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.

Measured Values
    EFV+ddI+FTC in Infants >=3 Months to < 6 Months     EFV+ddI+FTC in Infants >=6 Months to < 2 Years     EFV+ddI+FTC in Children >= 2 Years to < 3 Years     EFV+ddI+FTC in Children >= 3 Years to <= 6 Years     EFV+ddI+FTC in All Participants  
Number of Participants Analyzed  
[units: participants]
  13     10     4     7     34  
Log10 c/mL HIV RNA Changes From Baseline at Weeks 60, 72, 84 and 96 - Treated Participants  
[units: log10 c/mL]
Median ( Inter-Quartile Range )
         
Baseline (n=13,10,4,7,34)     5.88  
  ( 5.12 to 5.92 )  
  5.88  
  ( 5.32 to 5.88 )  
  5.88  
  ( 5.38 to 5.88 )  
  5.50  
  ( 4.64 to 5.88 )  
  5.88  
  ( 4.97 to 5.88 )  
Week 60 (n=7, 8, 3, 4, 22)     -3.92  
  ( -418 to -1.94 )  
  -3.44  
  ( -4.18 to -1.46 )  
  -3.26  
  ( -4.18 to -3.18 )  
  -3.48  
  ( -4.10 to -2.32 )  
  -3.50  
  ( -4.18 to -1.94 )  
Week 72 (n=7, 6, 1, 3, 17)     -4.08  
  ( -4.24 to -1.94 )  
  -2.75  
  ( -418 to -1.83 )  
  -3.20  
  ( -3.20 to -3.20 )  
  -4.18  
  ( -4.18 to -2.95 )  
  -3.45  
  ( -4.18 to -2.21 )  
Week 84 (n=7, 7, 2, 4, 20)     -4.08  
  ( -4.24 to -1.94 )  
  -3.28  
  ( -4.18 to -1.54 )  
  -2.18  
  ( -3.20 to -1.16 )  
  -3.51  
  ( -4.13 to 02.32 )  
  -3.37  
  ( -4.18 to -1.81 )  
Week 96 (n=7, 6, 2, 4, 19)     -3.82  
  ( -4.18 to -1.94 )  
  -3.73  
  ( -4.18 to -1.19 )  
  -2.15  
  ( -2.99 to -1.30 )  
  -3.57  
  ( -4.18 to -2.32 )  
  -3.45  
  ( -4.18 to -1.69 )  

No statistical analysis provided for Log10 c/mL HIV RNA Changes From Baseline at Weeks 60, 72, 84 and 96 - Treated Participants



27.  Secondary:   CD4 Cell Count Change From Baseline at Weeks 60, 72, 84, and 96 - Treated Participants   [ Time Frame: Baseline to Weeks 60, 72, 84, and 96 ]

Measure Type Secondary
Measure Title CD4 Cell Count Change From Baseline at Weeks 60, 72, 84, and 96 - Treated Participants
Measure Description A CD4 cell is an antigenic marker of helper/inducer T cells. These cells were counted during the hematology cell counts performed during a Complete Blood Cell count (CBC) performed by the Central Laboratory. CD4 are measured as number of cells per millimeters to the third power (cells/mm^3). An increase from baseline in the number of CD4 cells is an improvement. The Baseline visit was within 50 days after the screening visit and was prior to start of study medication (Week 1).
Time Frame Baseline to Weeks 60, 72, 84, and 96  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated participants who received at least 1 dose of study drug (EFV) were analyzed. n=number of participants with available data at both baseline and each specific week on treatment.

Reporting Groups
  Description
EFV+ddI+FTC in Infants >=3 Months to < 6 Months EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Infants >=6 Months to < 2 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Children >= 2 Years to < 3 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Children >= 3 Years to <= 6 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in All Participants All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.

Measured Values
    EFV+ddI+FTC in Infants >=3 Months to < 6 Months     EFV+ddI+FTC in Infants >=6 Months to < 2 Years     EFV+ddI+FTC in Children >= 2 Years to < 3 Years     EFV+ddI+FTC in Children >= 3 Years to <= 6 Years     EFV+ddI+FTC in All Participants  
Number of Participants Analyzed  
[units: participants]
  10     9     3     6     28  
CD4 Cell Count Change From Baseline at Weeks 60, 72, 84, and 96 - Treated Participants  
[units: cells/mm^3]
Median ( Inter-Quartile Range )
         
Baseline (n=10,9,3,6,28)     1518  
  ( 829 to 2202 )  
  1569  
  ( 1149 to 2284 )  
  517  
  ( 129 to 558 )  
  413  
  ( 23 to 688 )  
  1144  
  ( 529 to 1930 )  
Week 60 (n=6, 6, 2,3,17)     -870  
  ( -1331 to -315 )  
  -914  
  ( -1509 to 725 )  
  580  
  ( -11 to 1171 )  
  676  
  ( 506 to 887 )  
  -315  
  ( -1331 to 676 )  
Week 72 (n=5, 7, 1, 3, 16)     -1178  
  ( -1422 to -588 )  
  234  
  ( -1540 to 624 )  
  -50  
  ( -50 to -50 )  
  620  
  ( 619 to 811 )  
  92  
  ( -1300 to 620 )  
Week 84 (n=6, 7, 1, 3, 17)     -937  
  ( -1331 to -155 )  
  59  
  ( -1416 to 316 )  
  101  
  ( 101 to 101 )  
  497  
  ( 339 to 722 )  
  59  
  ( -1304 to 334 )  
Week 96 (n=6, 6, 1, 3, 16)     -834  
  ( -1437 to -176 )  
  -43  
  ( -1291 to 222 )  
  402  
  ( 402 to 402 )  
  744  
  ( 295 to 1243 )  
  -40  
  ( -1185 to 314 )  

No statistical analysis provided for CD4 Cell Count Change From Baseline at Weeks 60, 72, 84, and 96 - Treated Participants



28.  Secondary:   Percent of CD4 Cells Change From Baseline at Weeks 60, 72, 84, and 96 - Treated Participants   [ Time Frame: Baseline to Weeks 60, 72, 84, and 96 ]

Measure Type Secondary
Measure Title Percent of CD4 Cells Change From Baseline at Weeks 60, 72, 84, and 96 - Treated Participants
Measure Description A CD4 cell is an antigenic marker of helper/inducer T cells. These cells were counted during the hematology cell counts performed during a Complete Blood Cell count (CBC) performed by the Central Laboratory. CD4 are measured as number of cells per millimeter to the third power (cells/mm^3). Percent of CD4 cells is the number of CD4 cells per total number of cells measured*100. An increase in the percent of CD4 cells is an improvement. The Baseline visit was within 50 days after the screening visit and was prior to start of study medication (Week 1).
Time Frame Baseline to Weeks 60, 72, 84, and 96  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated participants who received at least 1 dose of study drug (EFV) were analyzed. n=number of participants with available data at both baseline and each specific week on treatment.

Reporting Groups
  Description
EFV+ddI+FTC in Infants >=3 Months to < 6 Months EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Infants >=6 Months to < 2 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Children >= 2 Years to < 3 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in Children >= 3 Years to <= 6 Years EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
EFV+ddI+FTC in All Participants All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.

Measured Values
    EFV+ddI+FTC in Infants >=3 Months to < 6 Months     EFV+ddI+FTC in Infants >=6 Months to < 2 Years     EFV+ddI+FTC in Children >= 2 Years to < 3 Years     EFV+ddI+FTC in Children >= 3 Years to <= 6 Years     EFV+ddI+FTC in All Participants  
Number of Participants Analyzed  
[units: participants]
  7     9     3     5     24  
Percent of CD4 Cells Change From Baseline at Weeks 60, 72, 84, and 96 - Treated Participants  
[units: percentage of CD4 cells]
Median ( Inter-Quartile Range )
         
Baseline (n=7,9,3,5,24)     28  
  ( 17 to 40 )  
  26  
  ( 25 to 28 )  
  12  
  ( 5 to 20 )  
  7  
  ( 2 to 23 )  
  24  
  ( 14 to 28 )  
Week 60 (n=3,6,2,3,14)     10  
  ( -9 to 13 )  
  3  
  ( -5 to 5 )  
  7  
  ( -1 to 15 )  
  13  
  ( 9 to 26 )  
  7  
  ( -1 to 13 )  
Week 72 (n=2,7,1,3,13)     -14  
  ( -17 to -10 )  
  1  
  ( -5 to 13 )  
  -1  
  ( -1 to -1 )  
  12  
  ( 11 to 26 )  
  1  
  ( -5 to 12 )  
Week 84 (n=3,7,1,3,14)     -3  
  ( -22 to 21 )  
  8  
  ( 0 to 11 )  
  2  
  ( 2 to 2 )  
  12  
  ( 5 to 34 )  
  7  
  ( 0 to 12 )  
Week 96 (n=3,6,1,3,13)     -2  
  ( -19 to 6 )  
  7  
  ( 3 to 10 )  
  15  
  ( 15 to 15 )  
  14  
  ( 14 to 28 )  
  7  
  ( 3 to 14 )  

No statistical analysis provided for Percent of CD4 Cells Change From Baseline at Weeks 60, 72, 84, and 96 - Treated Participants




  Serious Adverse Events


  Other Adverse Events


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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
e-mail: Clinical.Trials@bms.com


No publications provided


Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00364793     History of Changes
Other Study ID Numbers: AI266-922
Study First Received: August 15, 2006
Results First Received: March 6, 2014
Last Updated: April 11, 2014
Health Authority: United States: Food and Drug Administration