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Atazanavir Used in Combination With Other Anti-HIV Drugs in HIV-Infected Infants, Children, and Adolescents

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ClinicalTrials.gov Identifier: NCT00006604
Recruitment Status : Completed
First Posted : August 31, 2001
Results First Posted : April 5, 2016
Last Update Posted : April 5, 2016
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV Infections
Interventions Drug: ATV
Drug: Ritonavir
Enrollment 195

Recruitment Details Date of First Enrollment: 16 November 2000; Date of Last Enrollment: 22 December 2009
Pre-assignment Details  
Arm/Group Title Group 1: ATV Dose: Powder (310mg/m^2) Group 1: ATV Dose: Powder (620mg/m^2) Group 2: ATV Powder (310mg/m^2) Group 2: ATV Powder (620mg/m^2) Group 3: ATV Capsule (310mg/m^2) Group 3: ATV Capsule (415mg/m^2) Group 3: ATV Capsule (520mg/m^2) Group 4: ATV Capsule (310mg/m^2) Group 4: ATV Capsule (520mg/m^2) Group 4: ATV Capsule (620mg/m^2) Group 5: ATV Powder (310mg/m^2) + RTV Group 5a: ATV Powder (310mg/m^2) + RTV Group 6: ATV Powder (310mg/m^2) + RTV Group 7: ATV Capsule (310mg/m^2) + RTV Group 7: ATV Capsule (205mg/m^2) + RTV Group 8: ATV Capsule (310mg/m^2) + RTV Group 8: ATV Capsule (205mg/m^2) + RTV
Hide Arm/Group Description Group 1 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder) and two NRTIs. Group 1 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder) and two NRTIs. Group 2 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder) and two NRTIs. Group 2 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder) and two NRTIs. Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They will received ATV (capsule) and two NRTIs. Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.

Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.

Note: This is the final recommended dose for this group.

Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs. Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.

Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.

Note: This is the final recommended dose for this group.

Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.

Note: This is the final recommended dose for this group.

Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.

Note: This is the final recommended dose for this group.

Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.

Note: This is the final recommended dose for this group.

Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.

Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.

Note: This is the final recommended dose for this group.

Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.

Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.

Note: This is the final recommended dose for this group.

Period Title: Overall Study
Started 6 2 5 6 5 5 21 5 5 25 21 12 26 6 24 6 15
Completed 4 2 1 1 3 2 12 2 4 6 13 6 22 0 14 1 6
Not Completed 2 0 4 5 2 3 9 3 1 19 8 6 4 6 10 5 9
Reason Not Completed
Met study objective - no further FU             1             0             0             0             0             0             0             0             0             0             0             0             0             0             1             1             0
Randomization entry error-no RX, no FU             0             0             0             0             0             0             0             0             0             0             0             1             0             0             0             0             0
Death             0             0             0             0             0             0             0             0             0             1             1             1             0             0             0             0             0
Severe debilitation, unable to continue             0             0             0             0             0             0             3             0             0             5             0             2             1             0             2             0             0
Subj/Parent not able to get to clinic             0             0             0             1             1             0             1             0             0             1             2             1             1             1             3             0             0
Site closing             0             0             1             1             0             0             0             1             0             0             0             1             1             1             0             0             1
Withdrawal by Subject             1             0             2             0             1             2             2             0             1             3             2             0             1             2             1             0             1
Subj/parent not willing to adhere to req             0             0             1             3             0             0             3             1             0             6             3             0             0             2             3             3             4
Lost to Follow-up             0             0             0             0             0             0             0             1             0             2             0             0             0             0             0             1             3
Other Reason             0             0             0             0             0             1             0             0             0             1             0             0             0             0             0             0             0
Arm/Group Title Step I: Group 3 (ATV Final Dose: 520mg/m^2 Capsule) Step I: Group 4 (ATV Final Dose: 620mg/m^2 Capsule) Step I: Group 5 (ATV Final Dose: 310mg/m^2 Powder + RTV) Step I: Group 5a (ATV Final Dose: 310mg/m^2 Powder + RTV) Step I: Group 6 (ATV Final Dose: 310mg/m^2 Powder + RTV) Step I: Group 7 (ATV Final Dose: 205mg/m^2 Capsule + RTV) Step I: Group 8 (ATV Final Dose: 205mg/m^2 Capsule + RTV) Total
Hide Arm/Group Description

Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

ATV Final Recommended Dose: 520mg/m^2

Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

ATV Final Recommended Dose: 620mg/m^2

Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 310mg/m^2

Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 310mg/m^2

Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 310mg/m^2

Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 205mg/m^2

Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 205mg/m^2

Total of all reporting groups
Overall Number of Baseline Participants 21 25 21 11 26 24 14 142
Hide Baseline Analysis Population Description
Participants accrued and treated at the dose ultimately selected for their groups. NOTE: (1) Final Dose not established for Grps 1, 2; (2) Grp 5a started with n=12, but (1) participant inadvertently enrolled,never received ATV, final n=11; (3) Grp 8 started with n=15, but (1) participant inadvertently enrolled, never received ATV, final n=14.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 21 participants 25 participants 21 participants 11 participants 26 participants 24 participants 14 participants 142 participants
8.6
(6.3 to 12.5)
14.3
(13.1 to 20.2)
1.2
(0.3 to 2.0)
0.4
(0.3 to 0.5)
4.4
(2.0 to 12.0)
9
(5.6 to 12.7)
17
(13.9 to 21)
7
(0.3 to 21)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 25 participants 21 participants 11 participants 26 participants 24 participants 14 participants 142 participants
Female
11
  52.4%
18
  72.0%
8
  38.1%
6
  54.5%
12
  46.2%
11
  45.8%
9
  64.3%
75
  52.8%
Male
10
  47.6%
7
  28.0%
13
  61.9%
5
  45.5%
14
  53.8%
13
  54.2%
5
  35.7%
67
  47.2%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 21 participants 25 participants 21 participants 11 participants 26 participants 24 participants 14 participants 142 participants
White Non-Hispanic 4 0 0 0 1 0 0 5
Black Non-Hispanic 14 17 18 10 18 17 8 102
Hisp-Regardless of Race 3 7 2 1 7 5 5 30
More than one race 0 0 1 0 0 1 1 3
Unavailable 0 1 0 0 0 1 0 2
CD4 Count  
Median (Full Range)
Unit of measure:  Cells/mm^3
Number Analyzed 21 participants 25 participants 21 participants 11 participants 26 participants 24 participants 14 participants 142 participants
374
(105 to 963)
286
(11 to 476)
1306
(392 to 4875)
2125
(583 to 2715)
466
(62 to 1537)
540
(24 to 1800)
334
(1 to 548)
457
(1 to 4875)
CD4 Percent  
Median (Full Range)
Unit of measure:  Percentage of total lymphocytes
Number Analyzed 21 participants 25 participants 21 participants 11 participants 26 participants 24 participants 14 participants 142 participants
18
(7 to 36)
14
(1 to 39)
19
(7 to 53)
35
(10 to 46)
16
(2 to 34)
21
(1 to 43)
19
(0 to 40)
18
(0 to 53)
HIV-RNA  
Median (Full Range)
Unit of measure:  Log10 copies/ml
Number Analyzed 21 participants 25 participants 21 participants 11 participants 26 participants 24 participants 14 participants 142 participants
4.4
(3.5 to 5)
4.7
(3.6 to 6.5)
5
(4.4 to 5.6)
5
(5 to 6.5)
4.8
(4.1 to 5.1)
4.5
(3.4 to 5)
4.3
(3.5 to 5)
4.8
(3.4 to 6.5)
1.Primary Outcome
Title Number of Participants Who Experienced a Safety Endpoint of Interest Attributed to ATV
Hide Description

Total Bilirubin >= 5.1xULN, ECG Events and Other Grade 3+ toxicities attributed to study treatment.

The AEs were graded by the clinicians according to the Division of AIDS (DAIDS) Toxicity Table (see references in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening, Grade 5=Death. Relationship to study treatment was determined by the study team.

Time Frame From study entry up to week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients accrued at the final recommended dose for each group.
Arm/Group Title Step I: Group 3: ATV Dose: 520mg/m^2 Capsule Step I: Group 4: ATV Dose: 620mg/m^2 Capsule Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV
Hide Arm/Group Description:

Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

ATV Final Recommended Dose: 520mg/m^2

Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

ATV Final Recommended Dose: 620mg/m^2

Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 310mg/m^2

Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended: 310mg/m^2

Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 310mg/m^2

Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 205mg/m^2

Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 205mg/m^2

Overall Number of Participants Analyzed 21 25 21 11 26 24 14
Measure Type: Number
Unit of Measure: participants
Total Bilirubin >= 5.1xULN 1 4 0 0 0 4 4
Increase in PR Interval-Grade 1 11 4 3 1 4 5 1
Increase in PR Interval-Grade 2 1 1 0 0 0 0 0
Heart Rate-Grade 2 2 1 3 1 1 4 0
Heart Rate-Grade 3 1 0 1 0 0 0 0
Increase in QTc Interval-Grade 3 1 0 0 1 1 0 0
Other Grade 3+ Toxicities 0 3 0 2 0 1 0
2.Primary Outcome
Title Number of Participants Who Died
Hide Description [Not Specified]
Time Frame From study entry up to week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants accrued at the final recommended dose for each group.
Arm/Group Title Step I: Group 3: ATV Dose: 520mg/m^2 Capsule Step I: Group 4: ATV Dose: 620mg/m^2 Capsule Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV
Hide Arm/Group Description:

Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

ATV Final Recommended Dose: 520mg/m^2

Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

ATV Final Recommended Dose: 620mg/m^2

Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 310mg/m^2

Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 310mg/m^2

Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 310mg/m^2

Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 205mg/m^2

Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 205mg/m^2

Overall Number of Participants Analyzed 21 25 21 11 26 24 14
Measure Type: Number
Unit of Measure: participants
Death not attributed to ATV 0 1 1 1 0 0 0
Death attributed to ATV 0 0 0 0 0 0 0
3.Primary Outcome
Title Pharmacokinetic (PK) Parameter: Area Under the Curve (AUC24h)
Hide Description Pharmacokinetics were determined by non-compartmental analysis and AUC0–24hr calculated by the linear trapezoidal method.
Time Frame Week 1 (Day 7) Intensive PK-24hr (Pre-Dose, 1, 2, 3, 4, 6, 8, and 12 hours post-dose and the following day at 24-hours post-dose)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with intensive pharmacokinetic (PK) results at the final recommended dose for each group.
Arm/Group Title Step I: Group 3: ATV Dose: 520mg/m^2 Capsule Step I: Group 4: ATV Dose: 620mg/m^2 Capsule Step I: Group 5: ATV 310mg/m^2 Powder + RTV Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV
Hide Arm/Group Description:

Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

ATV Final Recommended Dose: 520mg/m^2

Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

ATV Final Recommended Dose: 620mg/m^2

Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 310mg/m^2

Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 310mg/m^2

Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 310mg/m^2

Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 205mg/m^2

Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 205mg/m^2

Overall Number of Participants Analyzed 20 21 17 11 21 21 14
Median (Inter-Quartile Range)
Unit of Measure: ng*hr/mL
40653
(25498 to 49784)
51781
(43287 to 78946)
44243
(27504 to 69168)
38928
(12005 to 54783)
52199
(39847 to 76995)
45680
(35379 to 55407)
42835
(37753 to 56663)
4.Primary Outcome
Title Pharmacokinetic (PK) Parameter: Minimum Plasma Concentration (C24)
Hide Description Pharmacokinetics were determined by non-compartmental analysis. C24 determined visually, except in the instance when the patient re-dosed the study medication prior to the 24 hour blood draw or the 24 hour level was not obtained, in which case the C24 was calculated from the elimination rate (ke) and the last measured concentration.
Time Frame Week 1 (Day 7) Intensive PK-24hr (Pre-dose, 1, 2, 3, 4, 6, 8, and 12 hours post-dose and the following day at 24-hours post-dose)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with intensive pharmacokinetic (PK) results at the final recommended dose for each group.
Arm/Group Title Step I: Group 3: ATV Dose: 520mg/m^2 Capsule Step I: Group 4: ATV Dose: 620mg/m^2 Capsule Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV
Hide Arm/Group Description:

Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

ATV Final Recommended Dose: 520mg/m^2

Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

ATV Final Recommended Dose: 620mg/m^2

Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 310mg/m^2

Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 310mg/m^2

Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 310mg/m^2

Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 205mg/m^2

Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 205mg/m^2

Overall Number of Participants Analyzed 20 21 17 11 21 21 14
Median (Inter-Quartile Range)
Unit of Measure: ng/mL
173
(99 to 317)
510
(245 to 761)
482
(194 to 627)
596
(138 to 810)
947
(521 to 1280)
575
(389 to 858)
885
(692 to 1491)
5.Primary Outcome
Title Pharmacokinetic (PK) Parameter: Maximum Plasma Concentration (Cmax)
Hide Description Pharmacokinetics were determined by non-compartmental analysis and Maximum concentration (Cmax) was determined visually.
Time Frame Week 1 (Day 7) Intensive PK-24 hr (Pre-dose, 1, 2, 3, 4, 6, 8, and 12 hours post-dose and the following day at 24-hours post-dose)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with intensive pharmacokinetic (PK) results at the final recommended dose for each group.
Arm/Group Title Step I: Group 3: ATV Dose 520mg/m^2 Capsule Step I: Group 4: ATV Dose: 620mg/m^2 Capsule Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV
Hide Arm/Group Description:

Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

ATV Final Recommended Dose: 520mg/m^2 Capsule

Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

ATV Final Recommended Dose: 620mg/m^2

Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended: 310mg/m^2

Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 310mg/m^2

Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 310mg/m^2

Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 205mg/m^2

Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 205mg/m^2

Overall Number of Participants Analyzed 20 21 17 11 21 21 14
Median (Inter-Quartile Range)
Unit of Measure: ng/mL
6463
(4994 to 8207)
7006
(5925 to 9324)
6501
(3218 to 9083)
4952
(1365 to 6070)
5593
(4151 to 7548)
5013
(3692 to 5993)
4095
(2947 to 5563)
6.Primary Outcome
Title Pharmacokinetic (PK) Parameter: Clearance (CL/F)
Hide Description Pharmacokinetics were determined by non-compartmental analysis and Apparent oral clearance (CL/F) was calculated as ATV dose divided by AUC0–24hr.
Time Frame Week 1 (Day 7) Intensive PK-24 hr (Pre-dose, 1, 2, 3, 4, 6, 8, and 12 hours post-dose and the following day at 24-hours post-dose)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with intensive pharmacokinetic (PK) results at the final recommended dose for each group.
Arm/Group Title Step I: Group 3: ATV Dose: 520mg/m^2 Capsule Step I: Group 4: ATV Dose: 620mg/m^2 Capsule Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV
Hide Arm/Group Description:

Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

ATV Final Recommended Dose: 520mg/m^2

Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

ATV Final Recommended Dose: 620mg/m^2

Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 310mg/m^2

Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 310mg/m^2

Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 310mg/m2

Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 205mg/m^2

Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 205mg/m^2

Overall Number of Participants Analyzed 20 21 17 11 21 21 14
Median (Inter-Quartile Range)
Unit of Measure: L/hr/m^2
12.8
(10.6 to 21.1)
11.4
(7.5 to 14.2)
7.9
(5.1 to 12)
8.3
(5.6 to 22.4)
5.3
(3.8 to 8.2)
4.7
(3.9 to 5.9)
4.8
(3.4 to 5.1)
7.Secondary Outcome
Title Percentage of Participants With HIV RNA <400 Copies/mL at Week 24
Hide Description Over the duration of the protocol, the assay used to determine Plasma HIV RNA levels was transitioned from the Amplicor HIV-1 Assay to the Amplicor HIV-1 Monitor 1.5 UltraSensitive Assay (Roche Molecular Systems, Branchburg, NJ) to finally the Abbott Real time HIV-1 RNA assay. The assays were performed according to the manufacturer’s instructions in a laboratory accredited by the College of American Pathologists and certified by the NIH Virology Quality Assurance (VQA) in the United States, and VQA certified in South Africa.
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Participants accrued at the final recommended dose for each group (with evaluable HIV-RNA data).

Virologic response, defined as achieving HIV-RNA < 400 copies/mL and remaining on treatment, was analyzed using an ‘intent-to-treat’ (ITT) approach, in which children who discontinued study treatment for any reason were considered failures.

Arm/Group Title Step I: Group 3: ATV Dose: 520mg/m^2 Capsule Step I: Group 4: ATV Dose: 620mg/m^2 Capsule Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV Step I: Group 6 : ATV Dose: 310mg/m^2 Powder + RTV Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV
Hide Arm/Group Description:

Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

ATV Final Recommended Dose: 520mg/m^2

Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

ATV Final Recommended Dose: 620mg/m^2

Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 310mg/m^2

Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 310mg/m^2

Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 310mg/m^2

Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended: 205mg/m^2

Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 205mg/m^2

Overall Number of Participants Analyzed 21 25 21 9 26 24 13
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
67
(43 to 85)
44
(24 to 65)
57
(34 to 78)
44
(14 to 79)
85
(65 to 96)
67
(45 to 84)
38
(14 to 79)
8.Secondary Outcome
Title Percentage of Participants With HIV RNA <400 Copies/mL at Week 48
Hide Description Over the duration of the protocol, the assay used to determine Plasma HIV RNA levels was transitioned from the Amplicor HIV-1 Assay to the Amplicor HIV-1 Monitor 1.5 UltraSensitive Assay (Roche Molecular Systems, Branchburg, NJ) to finally the Abbott Real time HIV-1 RNA assay. The assays were performed according to the manufacturer’s instructions in a laboratory accredited by the College of American Pathologists and certified by the NIH Virology Quality Assurance (VQA) in the United States, and VQA certified in South Africa.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Participants accrued at the final recommended dose for each group (with evaluable HIV-RNA data).

Virologic response, defined as achieving HIV-RNA < 400 copies/mL and remaining on treatment, was analyzed using an ‘intent-to-treat’ (ITT) approach, in which children who discontinued study treatment for any reason were considered failures.

Arm/Group Title Step I: Group 3: ATV Dose: 520mg/m^2 Capsule Step I: Group 4: ATV Dose: 620mg/m^2 Capsule Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV
Hide Arm/Group Description:

Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

ATV Final Recommended Dose: 520mg/m^2

Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

ATV Final Recommended Dose: 620mg/m^2

Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 310mg/m^2

Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 310mg/m^2

Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 310mg/m^2

Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 205mg/m^2

Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 205mg/m^2

Overall Number of Participants Analyzed 21 25 21 11 26 24 14
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
62
(38 to 82)
32
(15 to 54)
71
(48 to 89)
55
(23 to 83)
85
(65 to 96)
63
(41 to 81)
29
(8 to 58)
9.Secondary Outcome
Title Percentage of Participants With HIV RNA <400 Copies/mL at Week 96
Hide Description Over the duration of the protocol, the assay used to determine Plasma HIV RNA levels was transitioned from the Amplicor HIV-1 Assay to the Amplicor HIV-1 Monitor 1.5 UltraSensitive Assay (Roche Molecular Systems, Branchburg, NJ) to finally the Abbott Real time HIV-1 RNA assay. The assays were performed according to the manufacturer’s instructions in a laboratory accredited by the College of American Pathologists and certified by the NIH Virology Quality Assurance (VQA) in the United States, and VQA certified in South Africa.
Time Frame Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Participants accrued at the final recommended dose for each group (with evaluable HIV-RNA data).

Virologic response, defined as achieving HIV-RNA < 400 copies/mL and remaining on treatment, was analyzed using an ‘intent-to-treat’ (ITT) approach, in which children who discontinued study treatment for any reason were considered failures.

Arm/Group Title Step I: Group 3: ATV Dose: 520mg/m^2 Capsule Step I: Group 4: ATV Dose: 620mg/m^2 Capsule Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV
Hide Arm/Group Description:

Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

ATV Final Recommended Dose: 520mg/m^2

Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

ATV Final Recommended Dose: 620mg/m^2

Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 310mg/m^2

Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 310mg/m^2

Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 310mg/m^2

Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 205mg/m^2

Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 205mg/m^2

Overall Number of Participants Analyzed 21 25 20 5 26 24 14
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
48
(26 to 70)
20
(7 to 41)
75
(51 to 91)
20
(1 to 72)
73
(52 to 88)
63
(41 to 81)
14
(2 to 43)
10.Secondary Outcome
Title Change in CD4 Count (Cells/mm^3) From Baseline to Week 20
Hide Description [Not Specified]
Time Frame Baseline, Week 20
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Participants accrued at the final recommended dose for each group (with evaluable CD4 data).

CD4 changes from baseline were calculated in an ‘as-treated’ analysis’ such that only patients who tolerated the study treatment, and who had evaluable data were included in this analysis.

Arm/Group Title Step I: Group 3: ATV Dose: 520mg/m^2 Capsule Step I: Group 4: ATV Dose: 620mg/m^2 Capsule Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV
Hide Arm/Group Description:

Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

ATV Final Recommended Dose: 520mg/m^2

Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

ATV Final Recommended Dose: 620mg/m^2

Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 310mg/m^2

Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 310mg/m^2

Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 310mg/m^2

Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 205mg/m^2

Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 205mg/m^2

Overall Number of Participants Analyzed 19 17 17 7 24 21 9
Median (Full Range)
Unit of Measure: Cells/mm^3
120
(-138 to 599)
184
(-122 to 449)
286
(-1388 to 2306)
-294
(-858 to 1779)
312
(-615 to 1065)
176
(-368 to 935)
139
(-110 to 327)
11.Secondary Outcome
Title Change in CD4 Count (Cells/mm^3) From Baseline to Week 48
Hide Description [Not Specified]
Time Frame Baseline, Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Patients accrued to the final recommended dose for each group (with evaluable CD4 data).

CD4 changes from baseline were calculated in an ‘as-treated’ analysis’ such that only patients who tolerated the study treatment, and who had evaluable data were included in this analysis.

Arm/Group Title Step I: Group 3: ATV Dose: 520mg/m^2 Capsule Step I: Group 4: ATV Dose: 620mg/m^2 Capsule Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV
Hide Arm/Group Description:

Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

ATV Final Recommended Dose: 520mg/m^2

Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

ATV Final Recommended Dose: 620mg/m^2

Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 310mg/m^2

Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 310mg/m^2

Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 310mg/m^2

Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 205mg/m^2

Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 205mg/m^2

Overall Number of Participants Analyzed 15 10 14 6 23 20 8
Median (Full Range)
Unit of Measure: Cells/mm^3
164
(60 to 590)
140
(-171 to 348)
74
(-912 to 1056)
-232
(-480 to 996)
324
(-297 to 1833)
157
(-306 to 1006)
135
(-194 to 422)
12.Secondary Outcome
Title Change in CD4 Count (Cells/mm^3) From Baseline to Week 96
Hide Description [Not Specified]
Time Frame Baseline, Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Patients accrued to the final recommended dose for each group (with evaluable CD4 data).

CD4 changes from baseline were calculated in an ‘as-treated’ analysis’ such that only patients who tolerated the study treatment, and who had evaluable data were included in this analysis.

Arm/Group Title Step I: Group 3: ATV Dose: 520mg/m^2 Capsule Step I: Group 4: ATV Dose: 620mg/m^2 Capsule Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV
Hide Arm/Group Description:

Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

ATV Final Recommended Dose: 520mg/m^2

Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

ATV Final Recommended Dose: 620mg/m^2

Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 310mg/m^2

Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 310mg/m^2

Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 310mg/m^2

Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended: 205mg/m^2

Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 205mg/m^2

Overall Number of Participants Analyzed 16 10 14 2 21 17 3
Median (Full Range)
Unit of Measure: cells/mm^3
366
(-114 to 916)
233
(92 to 410)
340
(-938 to 1640)
-600
(-828 to -371)
317
(28 to 1693)
260
(-106 to 1230)
293
(85 to 337)
13.Secondary Outcome
Title Change in CD4 Percent From Baseline to Week 20
Hide Description [Not Specified]
Time Frame Baseline, Week 20
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Patients accrued to the final recommended dose for each group (with evaluable CD4 data).

CD4 changes from baseline were calculated in an ‘as-treated’ analysis’ such that only patients who tolerated the study treatment, and who had evaluable data were included in this analysis.

Arm/Group Title Step I: Group 3: ATV Dose: 520mg/m^2 Capsule Step I: Group 4: ATV Dose: 620mg/m^2 Capsule Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV
Hide Arm/Group Description:

Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

ATV Final Recommended Dose: 520mg/m^2

Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

ATV Final Recommended Dose: 620mg/m^2

Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 310mg/m^2

Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 310mg/m^2

Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 310mg/m^2

Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 205mg/m^2

Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 205mg/m^2

Overall Number of Participants Analyzed 19 17 17 7 24 22 9
Median (Full Range)
Unit of Measure: percentage of total lymphocytes
8
(-2 to 16)
6
(-5 to 16)
8
(-9 to 22)
6
(-16 to 12)
11
(3 to 24)
7
(-7 to 17)
3
(-1 to 10)
14.Secondary Outcome
Title Change in CD4 Percent From Baseline to Week 48
Hide Description [Not Specified]
Time Frame Baseline, Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Patients accrued to the final recommended dose for each group (with evaluable CD4 data).

CD4 changes from baseline were calculated in an ‘as-treated’ analysis’ such that only patients who tolerated the study treatment, and who had evaluable data were included in this analysis.

Arm/Group Title Step I: Group 3: ATV Dose: 520mg/m^2 Capsule Step I: Group 4: ATV Dose: 620mg/m^2 Capsule Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV
Hide Arm/Group Description:

Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

ATV Final Recommended Dose: 520mg/m^2

Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

ATV Final Recommended Dose: 620mg/m^2

Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 310mg/m^2

Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 310mg/m^2

Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 310mg/m^2

Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 205mg/m^2

Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 205mg/m^2

Overall Number of Participants Analyzed 15 10 14 6 23 20 8
Median (Full Range)
Unit of Measure: percentage of total lymphocytes
7
(-3 to 18)
9
(-1 to 15)
10
(-4 to 20)
0
(-14 to 12)
12
(-1 to 30)
8
(-6 to 26)
5
(0 to 23)
15.Secondary Outcome
Title Change in CD4 Percent From Baseline to Week 96
Hide Description [Not Specified]
Time Frame Baseline, Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Patients accrued to the final recommended dose for each group (with evaluable CD4 data).

CD4 changes from baseline were calculated in an ‘as-treated’ analysis’ such that only patients who tolerated the study treatment, and who had evaluable data were included in this analysis.

Arm/Group Title Step I: Group 3: ATV Dose: 520mg/m^2 Capsule Step I: Group 4: ATV Dose: 620mg/m^2 Capsule Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV
Hide Arm/Group Description:

Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

ATV Final Recommended Dose: 520mg/m^2

Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

ATV Final Recommended Dose: 620mg/m^2

Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 310mg/m^2

Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 310mg/m^2

Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 310mg/m^2

Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 205mg/m^2

Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.

ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.

Ritonavir: Administered as 100 mg capsules or oral solution.

ATV Final Recommended Dose: 205mg/m^2

Overall Number of Participants Analyzed 16 10 14 2 21 17 3
Median (Full Range)
Unit of Measure: percentage of total lymphocytes
14
(1 to 26)
9
(3 to 15)
10
(1 to 27)
-0.5
(-1 to 0)
15
(-1 to 32)
10
(-10 to 35)
9
(4 to 16)
Time Frame From first study enrollment (16 November 2000) up to the last off-study visit (15 September 2014)
Adverse Event Reporting Description P1020A followed intensive reporting requirements defined in DAIDS Serious Adverse Experience Reporting Manual. AEs graded according to the Division of AIDS (DAIDS) AE Grading Table (see references in the Protocol Section) as follows: Gr 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Potentially Life-Threatening, Gr 5=Death.
 
Arm/Group Title Group 3: ATV 520mg/m^2 Capsule Group 4: ATV 620mg/m^2 Capsule Group 5: ATV 310mg/m^2 Powder + RTV Group 6: ATV 310mg/m^2 Powder + RTV Group 7: ATV 205mg/m^2 Capsule + RTV Group 8: ATV 205mg/m^2 Capsule + RTV Group 5A: ATV 310mg/m^2 Powder + RTV
Hide Arm/Group Description

2 years and 1 day (731 days or more) to 13 years of age.

ATV capsule + 2 NRTIs

Note: This is the final recommended dose for this group.

13 years and 1 day to 21 (not including the 22nd birthday) years of age.

ATV capsule + 2 NRTIs

Note: This is the final recommended dose for this group.

91 days to 2 years of age (less than or exactly 730 days.

ATV powder + ritonavir + 2 NRTIs

Note: This is the final recommended dose for this group.

2 years and 1 day (731 days or more) to 13 years of age.

ATV powder + ritonavir + 2 NRTIs

Note: This is the final recommended dose for this group.

2 years and 1 day (731 days or more) to 13 years of age.

ATV capsule + ritonavir + 2 NRTIs

Note: This is the final recommended dose for this group.

13 years and 1 day to 21 (not including the 22nd birthday) years of age.

ATV capsule + ritonavir + 2 NRTIs

Note: This is the final recommended dose for this group.

91 to 180 days of age.

ATV powder + ritonavir + 2 NRTIs

Note: This is the final recommended dose for this group.

All-Cause Mortality
Group 3: ATV 520mg/m^2 Capsule Group 4: ATV 620mg/m^2 Capsule Group 5: ATV 310mg/m^2 Powder + RTV Group 6: ATV 310mg/m^2 Powder + RTV Group 7: ATV 205mg/m^2 Capsule + RTV Group 8: ATV 205mg/m^2 Capsule + RTV Group 5A: ATV 310mg/m^2 Powder + RTV
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Group 3: ATV 520mg/m^2 Capsule Group 4: ATV 620mg/m^2 Capsule Group 5: ATV 310mg/m^2 Powder + RTV Group 6: ATV 310mg/m^2 Powder + RTV Group 7: ATV 205mg/m^2 Capsule + RTV Group 8: ATV 205mg/m^2 Capsule + RTV Group 5A: ATV 310mg/m^2 Powder + RTV
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   10/21 (47.62%)   15/25 (60.00%)   12/21 (57.14%)   14/26 (53.85%)   15/24 (62.50%)   8/14 (57.14%)   5/11 (45.45%) 
Cardiac disorders               
Atrioventricular block second degree  1  0/21 (0.00%)  1/25 (4.00%)  0/21 (0.00%)  0/26 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  0/11 (0.00%) 
Cardiac failure congestive  1  0/21 (0.00%)  1/25 (4.00%)  0/21 (0.00%)  0/26 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  0/11 (0.00%) 
Cardiomyopathy  1  0/21 (0.00%)  1/25 (4.00%)  0/21 (0.00%)  0/26 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  0/11 (0.00%) 
Gastrointestinal disorders               
Pancreatitis acute  1  0/21 (0.00%)  1/25 (4.00%)  0/21 (0.00%)  0/26 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  0/11 (0.00%) 
Hepatobiliary disorders               
Hyperbilirubinaemia  1  3/21 (14.29%)  6/25 (24.00%)  2/21 (9.52%)  4/26 (15.38%)  3/24 (12.50%)  1/14 (7.14%)  1/11 (9.09%) 
Infections and infestations               
Meningitis  1  0/21 (0.00%)  0/25 (0.00%)  0/21 (0.00%)  0/26 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  1/11 (9.09%) 
Pneumonia  1  0/21 (0.00%)  0/25 (0.00%)  1/21 (4.76%)  0/26 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  0/11 (0.00%) 
Investigations               
Aspartate aminotransferase increased  1  0/21 (0.00%)  0/25 (0.00%)  1/21 (4.76%)  0/26 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  0/11 (0.00%) 
Bilirubin conjugated increased  1  0/21 (0.00%)  1/25 (4.00%)  0/21 (0.00%)  0/26 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  0/11 (0.00%) 
Blood alkaline phosphatase increased  1  0/21 (0.00%)  0/25 (0.00%)  0/21 (0.00%)  0/26 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  2/11 (18.18%) 
Blood bilirubin increased  1  7/21 (33.33%)  8/25 (32.00%)  6/21 (28.57%)  8/26 (30.77%)  10/24 (41.67%)  5/14 (35.71%)  0/11 (0.00%) 
Blood bilirubin unconjugated increased  1  1/21 (4.76%)  6/25 (24.00%)  5/21 (23.81%)  8/26 (30.77%)  9/24 (37.50%)  2/14 (14.29%)  0/11 (0.00%) 
Blood sodium decreased  1  0/21 (0.00%)  0/25 (0.00%)  1/21 (4.76%)  0/26 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  0/11 (0.00%) 
Electrocardiogram QT prolonged  1  1/21 (4.76%)  1/25 (4.00%)  0/21 (0.00%)  1/26 (3.85%)  0/24 (0.00%)  0/14 (0.00%)  1/11 (9.09%) 
Gamma-glutamyltransferase increased  1  0/21 (0.00%)  1/25 (4.00%)  0/21 (0.00%)  0/26 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  0/11 (0.00%) 
Lipase increased  1  0/21 (0.00%)  0/25 (0.00%)  1/21 (4.76%)  0/26 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  0/11 (0.00%) 
Liver function test abnormal  1  0/21 (0.00%)  1/25 (4.00%)  1/21 (4.76%)  0/26 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  0/11 (0.00%) 
Neutrophil count decreased  1  0/21 (0.00%)  0/25 (0.00%)  0/21 (0.00%)  0/26 (0.00%)  0/24 (0.00%)  1/14 (7.14%)  0/11 (0.00%) 
Metabolism and nutrition disorders               
Hyponatraemia  1  0/21 (0.00%)  0/25 (0.00%)  1/21 (4.76%)  0/26 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  0/11 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)               
Hodgkin's disease  1  0/21 (0.00%)  1/25 (4.00%)  0/21 (0.00%)  0/26 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  0/11 (0.00%) 
Pregnancy, puerperium and perinatal conditions               
Abortion spontaneous  1  0/21 (0.00%)  1/25 (4.00%)  0/21 (0.00%)  0/26 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  0/11 (0.00%) 
Renal and urinary disorders               
Glycosuria  1  0/21 (0.00%)  0/25 (0.00%)  0/21 (0.00%)  0/26 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  0/11 (0.00%) 
Skin and subcutaneous tissue disorders               
Facial wasting  1  1/21 (4.76%)  0/25 (0.00%)  0/21 (0.00%)  0/26 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  0/11 (0.00%) 
Lipoatrophy  1  0/21 (0.00%)  0/25 (0.00%)  1/21 (4.76%)  0/26 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  0/11 (0.00%) 
Rash  1  0/21 (0.00%)  0/25 (0.00%)  0/21 (0.00%)  0/26 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  0/11 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Group 3: ATV 520mg/m^2 Capsule Group 4: ATV 620mg/m^2 Capsule Group 5: ATV 310mg/m^2 Powder + RTV Group 6: ATV 310mg/m^2 Powder + RTV Group 7: ATV 205mg/m^2 Capsule + RTV Group 8: ATV 205mg/m^2 Capsule + RTV Group 5A: ATV 310mg/m^2 Powder + RTV
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   21/21 (100.00%)   25/25 (100.00%)   21/21 (100.00%)   26/26 (100.00%)   24/24 (100.00%)   14/14 (100.00%)   11/11 (100.00%) 
Blood and lymphatic system disorders               
Iron deficiency anaemia  1  0/21 (0.00%)  0/25 (0.00%)  2/21 (9.52%)  2/26 (7.69%)  1/24 (4.17%)  0/14 (0.00%)  1/11 (9.09%) 
Lymph node pain  1  0/21 (0.00%)  0/25 (0.00%)  0/21 (0.00%)  0/26 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  1/11 (9.09%) 
Lymphadenitis  1  0/21 (0.00%)  0/25 (0.00%)  0/21 (0.00%)  0/26 (0.00%)  0/24 (0.00%)  1/14 (7.14%)  0/11 (0.00%) 
Lymphadenopathy  1  7/21 (33.33%)  10/25 (40.00%)  11/21 (52.38%)  7/26 (26.92%)  7/24 (29.17%)  1/14 (7.14%)  6/11 (54.55%) 
Splenomegaly  1  2/21 (9.52%)  1/25 (4.00%)  6/21 (28.57%)  0/26 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  2/11 (18.18%) 
Cardiac disorders               
Tachycardia  1  0/21 (0.00%)  0/25 (0.00%)  4/21 (19.05%)  1/26 (3.85%)  0/24 (0.00%)  0/14 (0.00%)  0/11 (0.00%) 
Ear and labyrinth disorders               
Ear pain  1  7/21 (33.33%)  3/25 (12.00%)  4/21 (19.05%)  8/26 (30.77%)  2/24 (8.33%)  2/14 (14.29%)  2/11 (18.18%) 
Hypoacusis  1  2/21 (9.52%)  0/25 (0.00%)  0/21 (0.00%)  0/26 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  0/11 (0.00%) 
Middle ear effusion  1  1/21 (4.76%)  0/25 (0.00%)  0/21 (0.00%)  0/26 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  1/11 (9.09%) 
Otorrhoea  1  3/21 (14.29%)  2/25 (8.00%)  7/21 (33.33%)  4/26 (15.38%)  3/24 (12.50%)  0/14 (0.00%)  2/11 (18.18%) 
Eye disorders               
Conjunctival hyperaemia  1  0/21 (0.00%)  0/25 (0.00%)  1/21 (4.76%)  0/26 (0.00%)  0/24 (0.00%)  1/14 (7.14%)  1/11 (9.09%) 
Eye discharge  1  5/21 (23.81%)  0/25 (0.00%)  5/21 (23.81%)  10/26 (38.46%)  2/24 (8.33%)  1/14 (7.14%)  2/11 (18.18%) 
Eye pain  1  0/21 (0.00%)  3/25 (12.00%)  3/21 (14.29%)  3/26 (11.54%)  2/24 (8.33%)  0/14 (0.00%)  0/11 (0.00%) 
Eye pruritus  1  3/21 (14.29%)  2/25 (8.00%)  4/21 (19.05%)  4/26 (15.38%)  4/24 (16.67%)  0/14 (0.00%)  0/11 (0.00%) 
Eye swelling  1  1/21 (4.76%)  0/25 (0.00%)  3/21 (14.29%)  1/26 (3.85%)  0/24 (0.00%)  0/14 (0.00%)  0/11 (0.00%) 
Eyelid oedema  1  0/21 (0.00%)  0/25 (0.00%)  3/21 (14.29%)  1/26 (3.85%)  0/24 (0.00%)  0/14 (0.00%)  0/11 (0.00%) 
Ocular hyperaemia  1  2/21 (9.52%)  2/25 (8.00%)  2/21 (9.52%)  6/26 (23.08%)  5/24 (20.83%)  1/14 (7.14%)  0/11 (0.00%) 
Ocular icterus  1  7/21 (33.33%)  7/25 (28.00%)  5/21 (23.81%)  7/26 (26.92%)  9/24 (37.50%)  3/14 (21.43%)  1/11 (9.09%) 
Gastrointestinal disorders               
Abdominal discomfort  1  0/21 (0.00%)  0/25 (0.00%)  0/21 (0.00%)  1/26 (3.85%)  0/24 (0.00%)  1/14 (7.14%)  0/11 (0.00%) 
Abdominal distension  1  0/21 (0.00%)  1/25 (4.00%)  2/21 (9.52%)  0/26 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  0/11 (0.00%) 
Abdominal pain  1  6/21 (28.57%)  6/25 (24.00%)  5/21 (23.81%)  5/26 (19.23%)  6/24 (25.00%)  2/14 (14.29%)  0/11 (0.00%) 
Abdominal pain lower  1  1/21 (4.76%)  0/25 (0.00%)  0/21 (0.00%)  0/26 (0.00%)  1/24 (4.17%)  1/14 (7.14%)  0/11 (0.00%) 
Abdominal pain upper  1  6/21 (28.57%)  5/25 (20.00%)  2/21 (9.52%)  4/26 (15.38%)  4/24 (16.67%)  1/14 (7.14%)  1/11 (9.09%) 
Abdominal tenderness  1  0/21 (0.00%)  0/25 (0.00%)  0/21 (0.00%)  0/26 (0.00%)  0/24 (0.00%)  1/14 (7.14%)  0/11 (0.00%) 
Constipation  1  0/21 (0.00%)  1/25 (4.00%)  1/21 (4.76%)  2/26 (7.69%)  2/24 (8.33%)  0/14 (0.00%)  0/11 (0.00%) 
Diarrhoea  1  7/21 (33.33%)  5/25 (20.00%)  12/21 (57.14%)  11/26 (42.31%)  7/24 (29.17%)  4/14 (28.57%)  8/11 (72.73%) 
Dysphagia  1  0/21 (0.00%)  1/25 (4.00%)  0/21 (0.00%)  0/26 (0.00%)  0/24 (0.00%)  1/14 (7.14%)  0/11 (0.00%) 
Gastritis  1  2/21 (9.52%)  0/25 (0.00%)  0/21 (0.00%)  1/26 (3.85%)  0/24 (0.00%)  0/14 (0.00%)  0/11 (0.00%) 
Gingival ulceration  1  0/21 (0.00%)  0/25 (0.00%)  0/21 (0.00%)  2/26 (7.69%)  0/24 (0.00%)  0/14 (0.00%)  0/11 (0.00%) 
Lip ulceration  1  0/21 (0.00%)  0/25 (0.00%)  2/21 (9.52%)  1/26 (3.85%)  0/24 (0.00%)  0/14 (0.00%)  0/11 (0.00%) 
Mouth ulceration  1  2/21 (9.52%)  2/25 (8.00%)  2/21 (9.52%)  2/26 (7.69%)  0/24 (0.00%)  0/14 (0.00%)  0/11 (0.00%) 
Nausea  1  4/21 (19.05%)  5/25 (20.00%)  1/21 (4.76%)  7/26 (26.92%)  2/24 (8.33%)  3/14 (21.43%)  0/11 (0.00%) 
Oral disorder  1  0/21 (0.00%)  3/25 (12.00%)  4/21 (19.05%)  0/26 (0.00%)  2/24 (8.33%)  0/14 (0.00%)  1/11 (9.09%) 
Proctalgia  1  1/21 (4.76%)  1/25 (4.00%)  0/21 (0.00%)  1/26 (3.85%)  0/24 (0.00%)  1/14 (7.14%)  0/11 (0.00%) 
Rectal fissure  1  0/21 (0.00%)  0/25 (0.00%)  0/21 (0.00%)  0/26 (0.00%)  0/24 (0.00%)  1/14 (7.14%)  0/11 (0.00%) 
Rectal haemorrhage  1  0/21 (0.00%)  0/25 (0.00%)  0/21 (0.00%)  0/26 (0.00%)  0/24 (0.00%)  1/14 (7.14%)  0/11 (0.00%) 
Rectal lesion  1  0/21 (0.00%)  0/25 (0.00%)  0/21 (0.00%)  0/26 (0.00%)  0/24 (0.00%)  1/14 (7.14%)  0/11 (0.00%) 
Stomatitis  1  0/21 (0.00%)  1/25 (4.00%)  2/21 (9.52%)  2/26 (7.69%)  2/24 (8.33%)  0/14 (0.00%)  0/11 (0.00%) 
Toothache  1  1/21 (4.76%)  1/25 (4.00%)  1/21 (4.76%)  5/26 (19.23%)  2/24 (8.33%)  0/14 (0.00%)  0/11 (0.00%) 
Vomiting  1  13/21 (61.90%)  8/25 (32.00%)  14/21 (66.67%)  19/26 (73.08%)  7/24 (29.17%)  3/14 (21.43%)  5/11 (45.45%) 
General disorders               
Asthenia  1  0/21 (0.00%)  3/25 (12.00%)  0/21 (0.00%)  0/26 (0.00%)  0/24 (0.00%)  1/14 (7.14%)  0/11 (0.00%) 
Chest pain  1  4/21 (19.05%)  6/25 (24.00%)  2/21 (9.52%)  4/26 (15.38%)  6/24 (25.00%)  0/14 (0.00%)  0/11 (0.00%) 
Chills  1  1/21 (4.76%)  0/25 (0.00%)  0/21 (0.00%)  0/26 (0.00%)  0/24 (0.00%)  1/14 (7.14%)  0/11 (0.00%) 
Face oedema  1  2/21 (9.52%)  0/25 (0.00%)  0/21 (0.00%)  0/26 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  0/11 (0.00%) 
Facial pain  1  0/21 (0.00%)  1/25 (4.00%)  0/21 (0.00%)  0/26 (0.00%)  2/24 (8.33%)  0/14 (0.00%)  0/11 (0.00%) 
Fatigue  1  1/21 (4.76%)  1/25 (4.00%)  1/21 (4.76%)  1/26 (3.85%)  0/24 (0.00%)  3/14 (21.43%)  1/11 (9.09%) 
Pain  1  3/21 (14.29%)  0/25 (0.00%)  0/21 (0.00%)  2/26 (7.69%)  1/24 (4.17%)  1/14 (7.14%)  0/11 (0.00%) 
Peripheral swelling  1  2/21 (9.52%)  3/25 (12.00%)  1/21 (4.76%)  1/26 (3.85%)  5/24 (20.83%)  1/14 (7.14%)  0/11 (0.00%) 
Pyrexia  1  14/21 (66.67%)  8/25 (32.00%)  15/21 (71.43%)  16/26 (61.54%)  9/24 (37.50%)  6/14 (42.86%)  8/11 (72.73%) 
Secretion discharge  1  3/21 (14.29%)  0/25 (0.00%)  0/21 (0.00%)  1/26 (3.85%)  0/24 (0.00%)  0/14 (0.00%)  0/11 (0.00%) 
Hepatobiliary disorders               
Hepatomegaly  1  0/21 (0.00%)  4/25 (16.00%)  6/21 (28.57%)  8/26 (30.77%)  4/24 (16.67%)  0/14 (0.00%)  1/11 (9.09%) 
Jaundice  1  2/21 (9.52%)  3/25 (12.00%)  2/21 (9.52%)  1/26 (3.85%)  2/24 (8.33%)  1/14 (7.14%)  0/11 (0.00%) 
Immune system disorders               
Immune reconstitution inflammatory syndrome  1  0/21 (0.00%)  0/25 (0.00%)  0/21 (0.00%)  0/26 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  1/11 (9.09%) 
Serum sickness  1  0/21 (0.00%)  0/25 (0.00%)  0/21 (0.00%)  0/26 (0.00%)  0/24 (0.00%)  1/14 (7.14%)  0/11 (0.00%) 
Infections and infestations               
Acarodermatitis  1  3/21 (14.29%)  2/25 (8.00%)  8/21 (38.10%)  5/26 (19.23%)  5/24 (20.83%)  0/14 (0.00%)  0/11 (0.00%) 
Acute sinusitis  1  2/21 (9.52%)  3/25 (12.00%)  1/21 (4.76%)  2/26 (7.69%)  0/24 (0.00%)  1/14 (7.14%)  0/11 (0.00%) 
Body tinea  1  1/21 (4.76%)  0/25 (0.00%)  6/21 (28.57%)  3/26 (11.54%)  2/24 (8.33%)  0/14 (0.00%)  0/11 (0.00%) 
Bronchiolitis  1  0/21 (0.00%)  0/25 (0.00%)  2/21 (9.52%)  1/26 (3.85%)  0/24 (0.00%)  0/14 (0.00%)  2/11 (18.18%) 
Bronchitis  1  0/21 (0.00%)  0/25 (0.00%)  2/21 (9.52%)  6/26 (23.08%)  1/24 (4.17%)  0/14 (0.00%)  1/11 (9.09%) 
Cellulitis  1  2/21 (9.52%)  2/25 (8.00%)  2/21 (9.52%)  2/26 (7.69%)  1/24 (4.17%)  1/14 (7.14%)  0/11 (0.00%) 
Conjunctivitis  1  6/21 (28.57%)  0/25 (0.00%)  4/21 (19.05%)  6/26 (23.08%)  5/24 (20.83%)  0/14 (0.00%)  2/11 (18.18%) 
Fungal skin infection  1  2/21 (9.52%)  0/25 (0.00%)  0/21 (0.00%)  0/26 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  0/11 (0.00%) 
Gastroenteritis  1  1/21 (4.76%)  2/25 (8.00%)  5/21 (23.81%)  4/26 (15.38%)  2/24 (8.33%)  2/14 (14.29%)  5/11 (45.45%) 
Gingivitis  1  1/21 (4.76%)  1/25 (4.00%)  2/21 (9.52%)  1/26 (3.85%)  1/24 (4.17%)  0/14 (0.00%)  0/11 (0.00%) 
Helminthic infection  1  0/21 (0.00%)  0/25 (0.00%)  0/21 (0.00%)  0/26 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  1/11 (9.09%) 
Hepatitis A  1  0/21 (0.00%)  0/25 (0.00%)  2/21 (9.52%)  0/26 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  0/11 (0.00%) 
Herpes zoster  1  2/21 (9.52%)  0/25 (0.00%)  0/21 (0.00%)  0/26 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  0/11 (0.00%) 
Immune reconstitution inflammatory syndrome associated tuberculosis  1  0/21 (0.00%)  0/25 (0.00%)  0/21 (0.00%)  0/26 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  1/11 (9.09%) 
Impetigo  1  3/21 (14.29%)  2/25 (8.00%)  4/21 (19.05%)  5/26 (19.23%)  4/24 (16.67%)  0/14 (0.00%)  4/11 (36.36%) 
Influenza  1  0/21 (0.00%)  0/25 (0.00%)  0/21 (0.00%)  0/26 (0.00%)  0/24 (0.00%)  1/14 (7.14%)  0/11 (0.00%) 
Lower respiratory tract infection  1  0/21 (0.00%)  0/25 (0.00%)  2/21 (9.52%)  0/26 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  0/11 (0.00%) 
Meningitis haemophilus  1  0/21 (0.00%)  0/25 (0.00%)  0/21 (0.00%)  0/26 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  1/11 (9.09%) 
Molluscum contagiosum  1  2/21 (9.52%)  1/25 (4.00%)  3/21 (14.29%)  0/26 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  0/11 (0.00%) 
Oesophageal candidiasis  1  0/21 (0.00%)  2/25 (8.00%)  0/21 (0.00%)  0/26 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  0/11 (0.00%) 
Oral candidiasis  1  2/21 (9.52%)  5/25 (20.00%)  4/21 (19.05%)  1/26 (3.85%)  0/24 (0.00%)  0/14 (0.00%)  2/11 (18.18%) 
Oral herpes  1  1/21 (4.76%)  3/25 (12.00%)  2/21 (9.52%)  4/26 (15.38%)  3/24 (12.50%)  0/14 (0.00%)  0/11 (0.00%) 
Otitis externa  1  0/21 (0.00%)  2/25 (8.00%)  2/21 (9.52%)  2/26 (7.69%)  1/24 (4.17%)  0/14 (0.00%)  0/11 (0.00%) 
Otitis media  1  7/21 (33.33%)  3/25 (12.00%)  8/21 (38.10%)  9/26 (34.62%)  2/24 (8.33%)  2/14 (14.29%)  3/11 (27.27%) 
Otitis media acute  1  2/21 (9.52%)  3/25 (12.00%)  11/21 (52.38%)  5/26 (19.23%)  3/24 (12.50%)  0/14 (0.00%)  2/11 (18.18%) 
Otitis media chronic  1  0/21 (0.00%)  0/25 (0.00%)  2/21 (9.52%)  1/26 (3.85%)  0/24 (0.00%)  0/14 (0.00%)  0/11 (0.00%) 
Parotitis  1  1/21 (4.76%)  1/25 (4.00%)  0/21 (0.00%)  0/26 (0.00%)  2/24 (8.33%)  0/14 (0.00%)  0/11 (0.00%) 
Pharyngitis  1  4/21 (19.05%)  5/25 (20.00%)  7/21 (33.33%)  10/26 (38.46%)  6/24 (25.00%)  1/14 (7.14%)  3/11 (27.27%) 
Pharyngitis streptococcal  1  4/21 (19.05%)  0/25 (0.00%)  1/21 (4.76%)  2/26 (7.69%)  1/24 (4.17%)  0/14 (0.00%)  0/11 (0.00%) 
Pneumonia  1  5/21 (23.81%)  3/25 (12.00%)  8/21 (38.10%)  6/26 (23.08%)  7/24 (29.17%)  0/14 (0.00%)  2/11 (18.18%) 
Pneumonia bacterial  1  0/21 (0.00%)  0/25 (0.00%)  1/21 (4.76%)  1/26 (3.85%)  1/24 (4.17%)  0/14 (0.00%)  2/11 (18.18%) 
Pneumonia viral  1  0/21 (0.00%)  0/25 (0.00%)  0/21 (0.00%)  0/26 (0.00%)  0/24 (0.00%)  1/14 (7.14%)  0/11 (0.00%) 
Pulmonary tuberculosis  1  2/21 (9.52%)  0/25 (0.00%)  0/21 (0.00%)  1/26 (3.85%)  1/24 (4.17%)  0/14 (0.00%)  2/11 (18.18%) 
Purulent discharge  1  2/21 (9.52%)  0/25 (0.00%)  2/21 (9.52%)  2/26 (7.69%)  1/24 (4.17%)  0/14 (0.00%)  4/11 (36.36%) 
Rash pustular  1  1/21 (4.76%)  1/25 (4.00%)  1/21 (4.76%)  1/26 (3.85%)  2/24 (8.33%)  0/14 (0.00%)  0/11 (0.00%) 
Sinusitis  1  2/21 (9.52%)  1/25 (4.00%)  0/21 (0.00%)  0/26 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  0/11 (0.00%) 
Sinusitis bacterial  1  2/21 (9.52%)  0/25 (0.00%)  0/21 (0.00%)  0/26 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  2/11 (18.18%) 
Skin candida  1  0/21 (0.00%)  0/25 (0.00%)  0/21 (0.00%)  0/26 (0.00%)  0/24 (0.00%)  1/14 (7.14%)  0/11 (0.00%) 
Staphylococcal abscess  1  0/21 (0.00%)  0/25 (0.00%)  1/21 (4.76%)  0/26 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  1/11 (9.09%) 
Staphylococcal impetigo  1  0/21 (0.00%)  0/25 (0.00%)  0/21 (0.00%)  0/26 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  1/11 (9.09%) 
Streptococcal impetigo  1  0/21 (0.00%)  0/25 (0.00%)  0/21 (0.00%)  0/26 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  1/11 (9.09%) 
Subcutaneous abscess  1  0/21 (0.00%)  0/25 (0.00%)  2/21 (9.52%)  1/26 (3.85%)  0/24 (0.00%)  0/14 (0.00%)  0/11 (0.00%) 
Tinea capitis  1  3/21 (14.29%)  0/25 (0.00%)  8/21 (38.10%)  6/26 (23.08%)  2/24 (8.33%)  0/14 (0.00%)  1/11 (9.09%) 
Tinea faciei  1  2/21 (9.52%)  0/25 (0.00%)  3/21 (14.29%)  1/26 (3.85%)  3/24 (12.50%)  0/14 (0.00%)  0/11 (0.00%) 
Tinea infection  1  9/21 (42.86%)  0/25 (0.00%)  7/21 (33.33%)  3/26 (11.54%)  3/24 (12.50%)  0/14 (0.00%)  0/11 (0.00%) 
Tinea pedis  1  0/21 (0.00%)  0/25 (0.00%)  0/21 (0.00%)  0/26 (0.00%)  0/24 (0.00%)  1/14 (7.14%)  0/11 (0.00%) 
Tinea versicolour  1  0/21 (0.00%)  2/25 (8.00%)  0/21 (0.00%)  0/26 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  0/11 (0.00%) 
Tonsillitis  1  5/21 (23.81%)  4/25 (16.00%)  8/21 (38.10%)  9/26 (34.62%)  4/24 (16.67%)  0/14 (0.00%)  0/11 (0.00%) 
Urinary tract infection  1  2/21 (9.52%)  2/25 (8.00%)  0/21 (0.00%)  0/26 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  0/11 (0.00%) 
Varicella  1  1/21 (4.76%)  1/25 (4.00%)  2/21 (9.52%)  3/26 (11.54%)  0/24 (0.00%)  0/14 (0.00%)  1/11 (9.09%) 
Injury, poisoning and procedural complications               
Arthropod bite  1  0/21 (0.00%)  0/25 (0.00%)  0/21 (0.00%)  3/26 (11.54%)  1/24 (4.17%)  0/14 (0.00%)  0/11 (0.00%) 
Contusion  1  2/21 (9.52%)  0/25 (0.00%)  0/21 (0.00%)  1/26 (3.85%)  0/24 (0.00%)  0/14 (0.00%)  0/11 (0.00%) 
Excoriation  1  0/21 (0.00%)  0/25 (0.00%)  0/21 (0.00%)  0/26 (0.00%)  0/24 (0.00%)  1/14 (7.14%)  0/11 (0.00%) 
Skin abrasion  1  0/21 (0.00%)  0/25 (0.00%)  0/21 (0.00%)  1/26 (3.85%)  0/24 (0.00%)  0/14 (0.00%)  1/11 (9.09%) 
Investigations               
Alanine aminotransferase increased  1  13/21 (61.90%)  14/25 (56.00%)  14/21 (66.67%)  15/26 (57.69%)  15/24 (62.50%)  5/14 (35.71%)  7/11 (63.64%) 
Aspartate aminotransferase increased  1  12/21 (57.14%)  16/25 (64.00%)  14/21 (66.67%)  15/26 (57.69%)  19/24 (79.17%)  5/14 (35.71%)  5/11 (45.45%) 
Bilirubin conjugated increased  1  14/21 (66.67%)  13/25 (52.00%)  13/21 (61.90%)  19/26 (73.08%)  19/24 (79.17%)  7/14 (50.00%)  5/11 (45.45%) 
Blood alkaline phosphatase increased  1  7/21 (33.33%)  5/25 (20.00%)  4/21 (19.05%)  6/26 (23.08%)  8/24 (33.33%)  1/14 (7.14%)  0/11 (0.00%) 
Blood bilirubin  1  0/21 (0.00%)  0/25 (0.00%)  1/21 (4.76%)  0/26 (0.00%)  2/24 (8.33%)  0/14 (0.00%)  0/11 (0.00%) 
Blood bilirubin increased  1  12/21 (57.14%)  12/25 (48.00%)  12/21 (57.14%)  18/26 (69.23%)  13/24 (54.17%)  7/14 (50.00%)  8/11 (72.73%) 
Blood bilirubin unconjugated  1  1/21 (4.76%)  1/25 (4.00%)  1/21 (4.76%)  3/26 (11.54%)  1/24 (4.17%)  0/14 (0.00%)  0/11 (0.00%) 
Blood bilirubin unconjugated increased  1  19/21 (90.48%)  16/25 (64.00%)  14/21 (66.67%)  18/26 (69.23%)  14/24 (58.33%)  11/14 (78.57%)  8/11 (72.73%) 
Blood calcium abnormal  1  0/21 (0.00%)  0/25 (0.00%)  1/21 (4.76%)  0/26 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  2/11 (18.18%) 
Blood calcium decreased  1  0/21 (0.00%)  2/25 (8.00%)  0/21 (0.00%)  1/26 (3.85%)  1/24 (4.17%)  0/14 (0.00%)  0/11 (0.00%) 
Blood calcium increased  1  0/21 (0.00%)  2/25 (8.00%)  3/21 (14.29%)  3/26 (11.54%)  0/24 (0.00%)  1/14 (7.14%)  2/11 (18.18%) 
Blood cholesterol abnormal  1  0/21 (0.00%)  0/25 (0.00%)  0/21 (0.00%)  0/26 (0.00%)  1/24 (4.17%)  1/14 (7.14%)  0/11 (0.00%) 
Blood cholesterol increased  1  10/21 (47.62%)  11/25 (44.00%)  17/21 (80.95%)  22/26 (84.62%)  13/24 (54.17%)  7/14 (50.00%)  7/11 (63.64%) 
Blood creatine phosphokinase increased  1  6/21 (28.57%)  1/25 (4.00%)  3/21 (14.29%)  1/26 (3.85%)  2/24 (8.33%)  1/14 (7.14%)  2/11 (18.18%) 
Blood creatinine increased  1  13/21 (61.90%)  5/25 (20.00%)  6/21 (28.57%)  8/26 (30.77%)  11/24 (45.83%)  4/14 (28.57%)  3/11 (27.27%) 
Blood glucose abnormal  1  2/21 (9.52%)  2/25 (8.00%)  3/21 (14.29%)  3/26 (11.54%)  4/24 (16.67%)  1/14 (7.14%)  1/11 (9.09%) 
Blood glucose decreased  1  15/21 (71.43%)  18/25 (72.00%)  16/21 (76.19%)  22/26 (84.62%)  14/24 (58.33%)  3/14 (21.43%)  6/11 (54.55%) 
Blood glucose increased  1  7/21 (33.33%)  9/25 (36.00%)  4/21 (19.05%)  10/26 (38.46%)  8/24 (33.33%)  3/14 (21.43%)  2/11 (18.18%) 
Blood magnesium decreased  1  2/21 (9.52%)  2/25 (8.00%)  0/21 (0.00%)  0/26 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  0/11 (0.00%) 
Blood potassium abnormal  1  6/21 (28.57%)  6/25 (24.00%)  14/21 (66.67%)  12/26 (46.15%)  12/24 (50.00%)  1/14 (7.14%)  9/11 (81.82%) 
Blood potassium decreased  1  10/21 (47.62%)  7/25 (28.00%)  10/21 (47.62%)  13/26 (50.00%)  8/24 (33.33%)  4/14 (28.57%)  3/11 (27.27%) 
Blood potassium increased  1  6/21 (28.57%)  9/25 (36.00%)  17/21 (80.95%)  18/26 (69.23%)  9/24 (37.50%)  1/14 (7.14%)  7/11 (63.64%) 
Blood sodium abnormal  1  1/21 (4.76%)  3/25 (12.00%)  1/21 (4.76%)  0/26 (0.00%)  1/24 (4.17%)  1/14 (7.14%)  1/11 (9.09%) 
Blood sodium decreased  1  17/21 (80.95%)  17/25 (68.00%)  17/21 (80.95%)  23/26 (88.46%)  18/24 (75.00%)  5/14 (35.71%)  10/11 (90.91%) 
Blood sodium increased  1  4/21 (19.05%)  4/25 (16.00%)  3/21 (14.29%)  2/26 (7.69%)  6/24 (25.00%)  1/14 (7.14%)  1/11 (9.09%) 
Blood triglycerides increased  1  19/21 (90.48%)  19/25 (76.00%)  20/21 (95.24%)  25/26 (96.15%)  19/24 (79.17%)  7/14 (50.00%)  10/11 (90.91%) 
Blood urea abnormal  1  4/21 (19.05%)  4/25 (16.00%)  2/21 (9.52%)  4/26 (15.38%)  3/24 (12.50%)  0/14 (0.00%)  4/11 (36.36%) 
Blood uric acid increased  1  1/21 (4.76%)  1/25 (4.00%)  0/21 (0.00%)  0/26 (0.00%)  1/24 (4.17%)  1/14 (7.14%)  0/11 (0.00%) 
Breath sounds abnormal  1  3/21 (14.29%)  1/25 (4.00%)  3/21 (14.29%)  0/26 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  0/11 (0.00%) 
Cardiac murmur  1  0/21 (0.00%)  0/25 (0.00%)  1/21 (4.76%)  1/26 (3.85%)  0/24 (0.00%)  0/14 (0.00%)  1/11 (9.09%) 
Gamma-glutamyltransferase increased  1  6/21 (28.57%)  12/25 (48.00%)  12/21 (57.14%)  14/26 (53.85%)  10/24 (41.67%)  5/14 (35.71%)  5/11 (45.45%) 
Haemoglobin decreased  1  11/21 (52.38%)  11/25 (44.00%)  14/21 (66.67%)  21/26 (80.77%)  12/24 (50.00%)  3/14 (21.43%)  6/11 (54.55%) 
High density lipoprotein abnormal  1  0/21 (0.00%)  0/25 (0.00%)  2/21 (9.52%)  0/26 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  0/11 (0.00%) 
Low density lipoprotein abnormal  1  0/21 (0.00%)  0/25 (0.00%)  2/21 (9.52%)  1/26 (3.85%)  0/24 (0.00%)  0/14 (0.00%)  0/11 (0.00%) 
Neutrophil count decreased  1  11/21 (52.38%)  11/25 (44.00%)  19/21 (90.48%)  17/26 (65.38%)  14/24 (58.33%)  7/14 (50.00%)  8/11 (72.73%) 
Pancreatic enzymes abnormal  1  0/21 (0.00%)  2/25 (8.00%)  7/21 (33.33%)  1/26 (3.85%)  3/24 (12.50%)  1/14 (7.14%)  0/11 (0.00%) 
Weight decreased  1  3/21 (14.29%)  4/25 (16.00%)  3/21 (14.29%)  2/26 (7.69%)  5/24 (20.83%)  0/14 (0.00%)  1/11 (9.09%) 
Metabolism and nutrition disorders               
Abnormal weight gain  1  0/21 (0.00%)  0/25 (0.00%)  0/21 (0.00%)  0/26 (0.00%)  0/24 (0.00%)  1/14 (7.14%)  0/11 (0.00%) 
Decreased appetite  1  4/21 (19.05%)  3/25 (12.00%)  7/21 (33.33%)  10/26 (38.46%)  4/24 (16.67%)  1/14 (7.14%)  5/11 (45.45%) 
Failure to thrive  1  1/21 (4.76%)  3/25 (12.00%)  3/21 (14.29%)  0/26 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  1/11 (9.09%) 
Hyperkalaemia  1  0/21 (0.00%)  1/25 (4.00%)  2/21 (9.52%)  0/26 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  0/11 (0.00%) 
Hyponatraemia  1  0/21 (0.00%)  2/25 (8.00%)  0/21 (0.00%)  0/26 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  0/11 (0.00%) 
Musculoskeletal and connective tissue disorders               
Arthralgia  1  3/21 (14.29%)  2/25 (8.00%)  0/21 (0.00%)  2/26 (7.69%)  1/24 (4.17%)  1/14 (7.14%)  1/11 (9.09%) 
Clubbing  1  4/21 (19.05%)  1/25 (4.00%)  4/21 (19.05%)  6/26 (23.08%)  3/24 (12.50%)  0/14 (0.00%)  0/11 (0.00%) 
Joint swelling  1  0/21 (0.00%)  0/25 (0.00%)  1/21 (4.76%)  0/26 (0.00%)  0/24 (0.00%)  1/14 (7.14%)  0/11 (0.00%) 
Lower extremity mass  1  0/21 (0.00%)  0/25 (0.00%)  0/21 (0.00%)  0/26 (0.00%)  0/24 (0.00%)  1/14 (7.14%)  0/11 (0.00%) 
Musculoskeletal discomfort  1  0/21 (0.00%)  0/25 (0.00%)  0/21 (0.00%)  0/26 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  1/11 (9.09%) 
Musculoskeletal stiffness  1  2/21 (9.52%)  1/25 (4.00%)  0/21 (0.00%)  0/26 (0.00%)  1/24 (4.17%)  0/14 (0.00%)  0/11 (0.00%) 
Myalgia  1  2/21 (9.52%)  0/25 (0.00%)  0/21 (0.00%)  0/26 (0.00%)  1/24 (4.17%)  1/14 (7.14%)  0/11 (0.00%) 
Pain in extremity  1  4/21 (19.05%)  4/25 (16.00%)  3/21 (14.29%)  3/26 (11.54%)  4/24 (16.67%)  2/14 (14.29%)  0/11 (0.00%) 
Pain in jaw  1  0/21 (0.00%)  0/25 (0.00%)  0/21 (0.00%)  0/26 (0.00%)  0/24 (0.00%)  1/14 (7.14%)  0/11 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)               
Skin papilloma  1  0/21 (0.00%)  1/25 (4.00%)  1/21 (4.76%)  2/26 (7.69%)  2/24 (8.33%)  0/14 (0.00%)  0/11 (0.00%) 
Nervous system disorders               
Amnesia  1  0/21 (0.00%)  0/25 (0.00%)  0/21 (0.00%)  0/26 (0.00%)  0/24 (0.00%)  1/14 (7.14%)  0/11 (0.00%) 
Dizziness  1  3/21 (14.29%)  4/25 (16.00%)  0/21 (0.00%)  0/26 (0.00%)  1/24 (4.17%)  1/14 (7.14%)  1/11 (9.09%) 
Epilepsy  1  2/21 (9.52%)  0/25 (0.00%)  0/21 (0.00%)  0/26 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  0/11 (0.00%) 
Febrile convulsion  1  0/21 (0.00%)  0/25 (0.00%)  2/21 (9.52%)  0/26 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  0/11 (0.00%) 
Headache  1  9/21 (42.86%)  7/25 (28.00%)  3/21 (14.29%)  6/26 (23.08%)  4/24 (16.67%)  2/14 (14.29%)  1/11 (9.09%) 
Paraesthesia  1  2/21 (9.52%)  0/25 (0.00%)  0/21 (0.00%)  0/26 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  0/11 (0.00%) 
Psychomotor hyperactivity  1  0/21 (0.00%)  0/25 (0.00%)  0/21 (0.00%)  0/26 (0.00%)  2/24 (8.33%)  0/14 (0.00%)  1/11 (9.09%) 
Seizure  1  1/21 (4.76%)  0/25 (0.00%)  3/21 (14.29%)  0/26 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  0/11 (0.00%) 
Somnolence  1  0/21 (0.00%)  0/25 (0.00%)  0/21 (0.00%)  0/26 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  1/11 (9.09%) 
Pregnancy, puerperium and perinatal conditions               
Pregnancy  1  0/21 (0.00%)  2/25 (8.00%)  0/21 (0.00%)  0/26 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  0/11 (0.00%) 
Psychiatric disorders               
Agoraphobia  1  0/21 (0.00%)  0/25 (0.00%)  0/21 (0.00%)  0/26 (0.00%)  0/24 (0.00%)  1/14 (7.14%)  0/11 (0.00%) 
Anger  1  0/21 (0.00%)  0/25 (0.00%)  0/21 (0.00%)  0/26 (0.00%)  0/24 (0.00%)  1/14 (7.14%)  0/11 (0.00%) 
Anxiety disorder  1  0/21 (0.00%)  0/25 (0.00%)  0/21 (0.00%)  0/26 (0.00%)  0/24 (0.00%)  1/14 (7.14%)  0/11 (0.00%) 
Attention deficit/hyperactivity disorder  1  1/21 (4.76%)  0/25 (0.00%)  3/21 (14.29%)  1/26 (3.85%)  3/24 (12.50%)  0/14 (0.00%)  0/11 (0.00%) 
Depression  1  1/21 (4.76%)  2/25 (8.00%)  0/21 (0.00%)  1/26 (3.85%)  0/24 (0.00%)  3/14 (21.43%)  0/11 (0.00%) 
Insomnia  1  0/21 (0.00%)  0/25 (0.00%)  0/21 (0.00%)  0/26 (0.00%)  0/24 (0.00%)  1/14 (7.14%)  0/11 (0.00%) 
Major depression  1  0/21 (0.00%)  0/25 (0.00%)  0/21 (0.00%)  2/26 (7.69%)  1/24 (4.17%)  0/14 (0.00%)  0/11 (0.00%) 
Panic disorder  1  0/21 (0.00%)  0/25 (0.00%)  0/21 (0.00%)  0/26 (0.00%)  0/24 (0.00%)  1/14 (7.14%)  0/11 (0.00%) 
Renal and urinary disorders               
Dysuria  1  0/21 (0.00%)  1/25 (4.00%)  0/21 (0.00%)  2/26 (7.69%)  2/24 (8.33%)  0/14 (0.00%)  0/11 (0.00%) 
Enuresis  1  0/21 (0.00%)  0/25 (0.00%)  2/21 (9.52%)  2/26 (7.69%)  0/24 (0.00%)  0/14 (0.00%)  0/11 (0.00%) 
Proteinuria  1  0/21 (0.00%)  0/25 (0.00%)  0/21 (0.00%)  2/26 (7.69%)  1/24 (4.17%)  0/14 (0.00%)  0/11 (0.00%) 
Urinary incontinence  1  0/21 (0.00%)  0/25 (0.00%)  0/21 (0.00%)  0/26 (0.00%)  0/24 (0.00%)  1/14 (7.14%)  0/11 (0.00%) 
Reproductive system and breast disorders               
Amenorrhoea  1  0/21 (0.00%)  1/25 (4.00%)  0/21 (0.00%)  0/26 (0.00%)  0/24 (0.00%)  1/14 (7.14%)  0/11 (0.00%) 
Fibrocystic breast disease  1  0/21 (0.00%)  0/25 (0.00%)  0/21 (0.00%)  0/26 (0.00%)  0/24 (0.00%)  1/14 (7.14%)  0/11 (0.00%) 
Genital rash  1  0/21 (0.00%)  1/25 (4.00%)  0/21 (0.00%)  0/26 (0.00%)  2/24 (8.33%)  0/14 (0.00%)  0/11 (0.00%) 
Perineal rash  1  0/21 (0.00%)  0/25 (0.00%)  0/21 (0.00%)  1/26 (3.85%)  0/24 (0.00%)  0/14 (0.00%)  1/11 (9.09%) 
Vaginal discharge  1  1/21 (4.76%)  3/25 (12.00%)  0/21 (0.00%)  3/26 (11.54%)  1/24 (4.17%)  0/14 (0.00%)  0/11 (0.00%) 
Vaginal haemorrhage  1  0/21 (0.00%)  2/25 (8.00%)  0/21 (0.00%)  1/26 (3.85%)  0/24 (0.00%)  0/14 (0.00%)  0/11 (0.00%) 
Vulval disorder  1  0/21 (0.00%)  0/25 (0.00%)  0/21 (0.00%)  0/26 (0.00%)  0/24 (0.00%)  1/14 (7.14%)  0/11 (0.00%) 
Vulvovaginal pruritus  1  2/21 (9.52%)  1/25 (4.00%)  0/21 (0.00%)  1/26 (3.85%)  3/24 (12.50%)  0/14 (0.00%)  0/11 (0.00%) 
Vulvovaginal rash  1  0/21 (0.00%)  0/25 (0.00%)  0/21 (0.00%)  0/26 (0.00%)  2/24 (8.33%)  0/14 (0.00%)  1/11 (9.09%) 
Respiratory, thoracic and mediastinal disorders               
Asthma  1  3/21 (14.29%)  1/25 (4.00%)  5/21 (23.81%)  2/26 (7.69%)  0/24 (0.00%)  0/14 (0.00%)  2/11 (18.18%) 
Bronchial hyperreactivity  1  1/21 (4.76%)  2/25 (8.00%)  1/21 (4.76%)  5/26 (19.23%)  2/24 (8.33%)  0/14 (0.00%)  0/11 (0.00%) 
Bronchiectasis  1  1/21 (4.76%)  0/25 (0.00%)  0/21 (0.00%)  0/26 (0.00%)  3/24 (12.50%)  0/14 (0.00%)  0/11 (0.00%) 
Bronchospasm  1  1/21 (4.76%)  1/25 (4.00%)  1/21 (4.76%)  2/26 (7.69%)  0/24 (0.00%)  0/14 (0.00%)  0/11 (0.00%) 
Cough  1  20/21 (95.24%)  16/25 (64.00%)  19/21 (90.48%)  26/26 (100.00%)  18/24 (75.00%)  9/14 (64.29%)  9/11 (81.82%) 
Dry throat  1  0/21 (0.00%)  0/25 (0.00%)  0/21 (0.00%)  0/26 (0.00%)  0/24 (0.00%)  1/14 (7.14%)  0/11 (0.00%) 
Dyspnoea  1  1/21 (4.76%)  1/25 (4.00%)  7/21 (33.33%)  2/26 (7.69%)  0/24 (0.00%)  1/14 (7.14%)  2/11 (18.18%) 
Epistaxis  1  2/21 (9.52%)  0/25 (0.00%)  4/21 (19.05%)  2/26 (7.69%)  2/24 (8.33%)  1/14 (7.14%)  0/11 (0.00%) 
Interstitial lung disease  1  0/21 (0.00%)  1/25 (4.00%)  0/21 (0.00%)  2/26 (7.69%)  0/24 (0.00%)  0/14 (0.00%)  0/11 (0.00%) 
Laryngeal inflammation  1  0/21 (0.00%)  0/25 (0.00%)  0/21 (0.00%)  0/26 (0.00%)  0/24 (0.00%)  1/14 (7.14%)  0/11 (0.00%) 
Nasal congestion  1  9/21 (42.86%)  4/25 (16.00%)  10/21 (47.62%)  14/26 (53.85%)  7/24 (29.17%)  3/14 (21.43%)  4/11 (36.36%) 
Nasal oedema  1  1/21 (4.76%)  0/25 (0.00%)  0/21 (0.00%)  0/26 (0.00%)  2/24 (8.33%)  0/14 (0.00%)  0/11 (0.00%) 
Nasal ulcer  1  0/21 (0.00%)  0/25 (0.00%)  2/21 (9.52%)  0/26 (0.00%)  1/24 (4.17%)  1/14 (7.14%)  0/11 (0.00%) 
Oropharyngeal pain  1  8/21 (38.10%)  7/25 (28.00%)  5/21 (23.81%)  11/26 (42.31%)  7/24 (29.17%)  3/14 (21.43%)  1/11 (9.09%) 
Paranasal sinus hypersecretion  1  0/21 (0.00%)  0/25 (0.00%)  1/21 (4.76%)  2/26 (7.69%)  0/24 (0.00%)  0/14 (0.00%)  2/11 (18.18%) 
Pharyngeal erythema  1  8/21 (38.10%)  0/25 (0.00%)  3/21 (14.29%)  5/26 (19.23%)  1/24 (4.17%)  1/14 (7.14%)  2/11 (18.18%) 
Pharyngeal inflammation  1  0/21 (0.00%)  0/25 (0.00%)  0/21 (0.00%)  2/26 (7.69%)  1/24 (4.17%)  0/14 (0.00%)  0/11 (0.00%) 
Pneumonia aspiration  1  0/21 (0.00%)  0/25 (0.00%)  1/21 (4.76%)  0/26 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  1/11 (9.09%) 
Pulmonary congestion  1  0/21 (0.00%)  0/25 (0.00%)  0/21 (0.00%)  2/26 (7.69%)  1/24 (4.17%)  0/14 (0.00%)  0/11 (0.00%) 
Rales  1  3/21 (14.29%)  1/25 (4.00%)  3/21 (14.29%)  5/26 (19.23%)  6/24 (25.00%)  0/14 (0.00%)  0/11 (0.00%) 
Respiratory tract congestion  1  0/21 (0.00%)  0/25 (0.00%)  0/21 (0.00%)  0/26 (0.00%)  2/24 (8.33%)  0/14 (0.00%)  0/11 (0.00%) 
Rhinorrhoea  1  13/21 (61.90%)  7/25 (28.00%)  13/21 (61.90%)  19/26 (73.08%)  7/24 (29.17%)  4/14 (28.57%)  7/11 (63.64%) 
Rhonchi  1  0/21 (0.00%)  1/25 (4.00%)  0/21 (0.00%)  4/26 (15.38%)  1/24 (4.17%)  1/14 (7.14%)  0/11 (0.00%) 
Sinus congestion  1  0/21 (0.00%)  1/25 (4.00%)  1/21 (4.76%)  0/26 (0.00%)  0/24 (0.00%)  1/14 (7.14%)  0/11 (0.00%) 
Sneezing  1  1/21 (4.76%)  0/25 (0.00%)  1/21 (4.76%)  3/26 (11.54%)  1/24 (4.17%)  1/14 (7.14%)  1/11 (9.09%) 
Tachypnoea  1  0/21 (0.00%)  1/25 (4.00%)  2/21 (9.52%)  1/26 (3.85%)  1/24 (4.17%)  0/14 (0.00%)  1/11 (9.09%) 
Throat irritation  1  0/21 (0.00%)  0/25 (0.00%)  0/21 (0.00%)  0/26 (0.00%)  0/24 (0.00%)  1/14 (7.14%)  0/11 (0.00%) 
Tonsillar hypertrophy  1  2/21 (9.52%)  1/25 (4.00%)  2/21 (9.52%)  4/26 (15.38%)  1/24 (4.17%)  0/14 (0.00%)  0/11 (0.00%) 
Wheezing  1  3/21 (14.29%)  2/25 (8.00%)  4/21 (19.05%)  8/26 (30.77%)  4/24 (16.67%)  1/14 (7.14%)  2/11 (18.18%) 
Skin and subcutaneous tissue disorders               
Acne  1  3/21 (14.29%)  2/25 (8.00%)  0/21 (0.00%)  3/26 (11.54%)  1/24 (4.17%)  1/14 (7.14%)  0/11 (0.00%) 
Blister  1  0/21 (0.00%)  0/25 (0.00%)  0/21 (0.00%)  1/26 (3.85%)  0/24 (0.00%)  0/14 (0.00%)  1/11 (9.09%) 
Dermatitis allergic  1  1/21 (4.76%)  0/25 (0.00%)  0/21 (0.00%)  0/26 (0.00%)  1/24 (4.17%)  1/14 (7.14%)  0/11 (0.00%) 
Dermatitis atopic  1  1/21 (4.76%)  0/25 (0.00%)  1/21 (4.76%)  2/26 (7.69%)  0/24 (0.00%)  1/14 (7.14%)  1/11 (9.09%) 
Dermatitis diaper  1  0/21 (0.00%)  0/25 (0.00%)  5/21 (23.81%)  1/26 (3.85%)  0/24 (0.00%)  0/14 (0.00%)  3/11 (27.27%) 
Drug eruption  1  0/21 (0.00%)  0/25 (0.00%)  0/21 (0.00%)  0/26 (0.00%)  0/24 (0.00%)  1/14 (7.14%)  0/11 (0.00%) 
Dry skin  1  4/21 (19.05%)  0/25 (0.00%)  2/21 (9.52%)  4/26 (15.38%)  3/24 (12.50%)  0/14 (0.00%)  1/11 (9.09%) 
Eczema  1  3/21 (14.29%)  4/25 (16.00%)  7/21 (33.33%)  6/26 (23.08%)  4/24 (16.67%)  0/14 (0.00%)  3/11 (27.27%) 
Eosinophilic pustular folliculitis  1  0/21 (0.00%)  2/25 (8.00%)  0/21 (0.00%)  0/26 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  0/11 (0.00%) 
Erythema  1  4/21 (19.05%)  0/25 (0.00%)  3/21 (14.29%)  1/26 (3.85%)  0/24 (0.00%)  0/14 (0.00%)  1/11 (9.09%) 
Exfoliative rash  1  0/21 (0.00%)  0/25 (0.00%)  0/21 (0.00%)  0/26 (0.00%)  0/24 (0.00%)  1/14 (7.14%)  0/11 (0.00%) 
Facial wasting  1  1/21 (4.76%)  0/25 (0.00%)  6/21 (28.57%)  5/26 (19.23%)  3/24 (12.50%)  0/14 (0.00%)  0/11 (0.00%) 
Lipoatrophy  1  2/21 (9.52%)  0/25 (0.00%)  1/21 (4.76%)  1/26 (3.85%)  1/24 (4.17%)  1/14 (7.14%)  0/11 (0.00%) 
Lipodystrophy acquired  1  1/21 (4.76%)  0/25 (0.00%)  2/21 (9.52%)  1/26 (3.85%)  0/24 (0.00%)  0/14 (0.00%)  0/11 (0.00%) 
Neurodermatitis  1  0/21 (0.00%)  0/25 (0.00%)  0/21 (0.00%)  0/26 (0.00%)  0/24 (0.00%)  1/14 (7.14%)  0/11 (0.00%) 
Papule  1  0/21 (0.00%)  1/25 (4.00%)  1/21 (4.76%)  2/26 (7.69%)  0/24 (0.00%)  1/14 (7.14%)  1/11 (9.09%) 
Pityriasis alba  1  0/21 (0.00%)  0/25 (0.00%)  1/21 (4.76%)  2/26 (7.69%)  0/24 (0.00%)  0/14 (0.00%)  0/11 (0.00%) 
Pruritus  1  1/21 (4.76%)  1/25 (4.00%)  1/21 (4.76%)  3/26 (11.54%)  3/24 (12.50%)  2/14 (14.29%)  0/11 (0.00%) 
Pruritus generalised  1  0/21 (0.00%)  0/25 (0.00%)  1/21 (4.76%)  1/26 (3.85%)  1/24 (4.17%)  2/14 (14.29%)  0/11 (0.00%) 
Rash  1  12/21 (57.14%)  11/25 (44.00%)  16/21 (76.19%)  13/26 (50.00%)  11/24 (45.83%)  4/14 (28.57%)  7/11 (63.64%) 
Rash generalised  1  3/21 (14.29%)  3/25 (12.00%)  7/21 (33.33%)  7/26 (26.92%)  3/24 (12.50%)  1/14 (7.14%)  2/11 (18.18%) 
Rash macular  1  1/21 (4.76%)  1/25 (4.00%)  0/21 (0.00%)  2/26 (7.69%)  0/24 (0.00%)  0/14 (0.00%)  0/11 (0.00%) 
Rash papular  1  1/21 (4.76%)  1/25 (4.00%)  1/21 (4.76%)  2/26 (7.69%)  3/24 (12.50%)  0/14 (0.00%)  0/11 (0.00%) 
Skin discolouration  1  2/21 (9.52%)  0/25 (0.00%)  0/21 (0.00%)  1/26 (3.85%)  1/24 (4.17%)  0/14 (0.00%)  0/11 (0.00%) 
Skin hyperpigmentation  1  1/21 (4.76%)  1/25 (4.00%)  2/21 (9.52%)  0/26 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  0/11 (0.00%) 
Skin lesion  1  7/21 (33.33%)  0/25 (0.00%)  8/21 (38.10%)  12/26 (46.15%)  9/24 (37.50%)  0/14 (0.00%)  3/11 (27.27%) 
Skin plaque  1  1/21 (4.76%)  0/25 (0.00%)  0/21 (0.00%)  0/26 (0.00%)  1/24 (4.17%)  1/14 (7.14%)  0/11 (0.00%) 
Skin ulcer  1  0/21 (0.00%)  0/25 (0.00%)  2/21 (9.52%)  0/26 (0.00%)  0/24 (0.00%)  0/14 (0.00%)  0/11 (0.00%) 
Swelling face  1  0/21 (0.00%)  0/25 (0.00%)  2/21 (9.52%)  0/26 (0.00%)  4/24 (16.67%)  0/14 (0.00%)  0/11 (0.00%) 
Umbilical haematoma  1  0/21 (0.00%)  0/25 (0.00%)  0/21 (0.00%)  0/26 (0.00%)  0/24 (0.00%)  1/14 (7.14%)  0/11 (0.00%) 
Urticaria  1  0/21 (0.00%)  0/25 (0.00%)  0/21 (0.00%)  3/26 (11.54%)  0/24 (0.00%)  1/14 (7.14%)  0/11 (0.00%) 
Urticaria chronic  1  0/21 (0.00%)  0/25 (0.00%)  0/21 (0.00%)  0/26 (0.00%)  0/24 (0.00%)  1/14 (7.14%)  0/11 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
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.
In accordance with the Clinical Trials Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights.
Results Point of Contact
Name/Title: Melissa Allen, Director, IMPAACT Operations Center
Organization: Family Health International (FHI 360)
Phone: (919) 405-1429
Publications:
Aldrovandi G, Samson P, Fenton T, Schnittman S, Rutstein R, Ortiz A and the Pediatric AIDS Clinical Trial 1020A Group. Resistance to Atazanavir (ATV), Lopinavir (LPV), Tenofovir (TFV) Among Heavily Experienced Pediatric Patients. 12th International Symposium on HIV and Emerging Infectious Diseases in Toulon, France, June 2002.
Aldrovandi G, Samson P, Fenton T, Schnittman S, and Rutstein R for the P1020A Team. Genotypic and phenotypic resistance to BMS232632 (Atazanavir-ATV), among heavily experienced pediatric patients who were ATV-naïve. 9th Conference on Retroviruses and Opportunistic Infections, February 24 - 28, 2002, Seattle, WA.
Kiser J, Rutstein R, Aldrovandi G, Samson P, Graham B, Schnittman S, Smith M, Mofenson L, Fletcher C, and the PACTG 1020A Study Team. Pharmacokinetics of atazanavir/ritonavir in HIV-infected infants, children, and adolescents: PACTG 1020A. 12th Conference on Retroviruses and Opportunistic Infections, Boston, MA, February 2005.
Kiser J, Rutstein R, Samson P, Graham B, Aldrovandi G, Mofenson L, Smith E, Zhang J, Biguenet S, Fletcher C, and the P1020A team. Atazanavir dosing conversion and pharmacokinetics in HIV-infected children switching from atazanavir powder to capsules. 12 th International Workshop on Clinical Pharmacology of HIV Therapy, Miami, Florida, April 2011.
Meyers T, Rutstein R, Samson P, Violari A, Palmer M, Kiser J, Fletcher C, Fenton T, Mofenson L, Graham B, Schnittman S, Horga M, Aldrovandi G, for the PACTG 1020A Study. Treatment responses to atazanavir-containing HAART in a drug-naïve pediatric population in South Africa. 15th Conference on Retroviruses and Opportunistic Infections, Boston, MA, February 2008.
Rutstein R, Samson P, Aldrovandi G, Graham B, Schnittman S, Fletcher C, Kiser J, Smith E, Mofenson L, Fenton T, and the PACTG 1020A Study Team. Effect of atazanavir on serum cholesterol and triglyceride levels in HIV-infected infants, children, and adolescents: PACTG 1020A. 12th Conference on Retroviruses and Opportunistic Infections, Boston, MA, February 2005.
Rutstein R, Samson P, Fenton T, Kiser J, Fletcher C, Schnittman S, Mofenson L, Smith E, Graham B, Aldrovandi G, PACTG 1020A Study. The NIH PACTG Protocol 1020A: ATAZANAVIR (ATV), +/- RITONAVIR in HIV-Infected Infants, Children and Adolescents. Presented at the 14th Conference on Retrovirus and Opportunistic Infection (CROI), Los Angeles, CA, February, 2007.
Samson P, Rutstein R, Schnittman S, Ortiz A, Graham B, Fenton T, Aldrovandi G and the Pediatric AIDS Clinical Trials Group P1020A Study Team. Effects of Antiretroviral (ARV) Exposure and Genotypic (Geno) Mutations in Predicting Phenotypic Resistance (PRS) to Atazanavir (ATV), Lopinavir (LPV), and Tenofovir (TDF) in Patients Naïve to these Drugs. 13th International Symposium on HIV and Emerging Infectious Diseases, Toulon, France, June 2004.
Samson P, Rutstein R, Fenton T, Kiser J, Fletcher C, Schnittman S, Mofenson L, Smith E, Graham B, Aldrovandi G, and the PACTG 1020A Study Team. Changes in cholesterol and triglyceride levels among pediatric subjects treated with atazanavir, with or without ritonavir boosting: the 1020A NIH PACTG protocol. 13th Conference on Retroviruses and Opportunistic Infections, Denver, CO, February 2006.
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00006604     History of Changes
Other Study ID Numbers: P1020A
10037 ( Registry Identifier: DAIDS ES )
IMPAACT P1020A
PACTG P1020-A
ACTG P1020-A
First Submitted: December 6, 2000
First Posted: August 31, 2001
Results First Submitted: January 29, 2016
Results First Posted: April 5, 2016
Last Update Posted: April 5, 2016