Phase IIIb Study to Evaluate the Effectiveness and Safety of Atazanavir/Ritonavir as Single Enhanced Protease Inhibitor Therapy in Human Immunodeficiency Virus (HIV)-Infected Subjects Evidencing Virologic Suppression (OREY)

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00337467
First received: June 14, 2006
Last updated: June 18, 2010
Last verified: June 2010
Results First Received: May 21, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Human Immunodeficiency Virus (HIV) Infections
Intervention: Drug: Atazanavir + Ritonavir

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
63 participants were enrolled in this study; 2 were never treated (1 no longer met study criteria and 1 concomitant medication not permitted).

Reporting Groups
  Description
Atazanavir (ATV)/Ritonavir (RTV) Monotherapy. ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)

Participant Flow:   Overall Study
    Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.  
STARTED     61  
Discontinued Prior to Week 96     10 [1]
COMPLETED     51  
NOT COMPLETED     10  
Adverse Event                 3  
Subject Withdrew Consent                 2  
Pregnancy                 1  
Lost to Follow-up                 2  
Subject No Longer Met Study Criteria                 2  
[1] 5 of these participants discontinued prior to Week 48



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Atazanavir (ATV)/Ritonavir (RTV) Monotherapy. ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)

Baseline Measures
    Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.  
Number of Participants  
[units: participants]
  61  
Age  
[units: years]
Mean ± Standard Deviation
  43  ± 9.5  
Gender  
[units: participants]
 
Female     15  
Male     46  
Race/Ethnicity, Customized  
[units: participants]
 
White     61  
Cluster of Differentiation 4 (CD4) Categories  
[units: participants]
 
CD4 Count <200 cells/mm3     3  
CD4 Count >=200 cells/mm3     58  
Human Immunodeficiency Ribonucleic Acid (HIV RNA) Categories  
[units: Participants]
 
HIV RNA <50 c/mL     60  
HIV RNA >=50 c/mL     1  
CD4 Count  
[units: cell/mm3]
Mean ± Standard Deviation
  559  ± 272.8  
Fasting High-Density Lipoprotein (HDL) Cholesterol [1]
[units: mg/dL]
Mean ± Standard Deviation
  45  ± 10.4  
Fasting Low-Density Lipoprotein (LDL) Cholesterol [1]
[units: mg/dL]
Mean ± Standard Deviation
  112  ± 52.3  
Fasting Non-HDL Cholesterol [1]
[units: mg/dL]
Mean ± Standard Deviation
  144  ± 57.9  
Fasting Total Cholesterol [1]
[units: mg/dL]
Mean ± Standard Deviation
  189  ± 57  
Fasting Triglycerides [1]
[units: mg/dL]
Mean ± Standard Deviation
  164  ± 95.7  
HIV RNA  
[units: log10 c/mL]
Mean ± Standard Deviation
  1.71  ± 0.152  
[1] Population analyzed = 54 (treated participants with baseline measure)



  Outcome Measures
  Hide All Outcome Measures

1.  Primary:   Percentage of Participants With Treatment Failure Through Week 48   [ Time Frame: Week 48 ]

Measure Type Primary
Measure Title Percentage of Participants With Treatment Failure Through Week 48
Measure Description Treatment Failure through Week 48 defined as virologic rebound (HIV RNA >=400 c/mL) on or before Week 48 or study discontinuation before Week 48. Virological rebound is defined as confirmed on-treatment HIV ribonucleic acid (RNA) >= 400 c/mL at 2 consecutive visits or last on-treatment HIV RNA >=400 c/mL followed by discontinuation of study therapy.
Time Frame Week 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated participants

Reporting Groups
  Description
Atazanavir (ATV)/Ritonavir (RTV) Monotherapy ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)

Measured Values
    Atazanavir (ATV)/Ritonavir (RTV) Monotherapy  
Number of Participants Analyzed  
[units: participants]
  61  
Percentage of Participants With Treatment Failure Through Week 48  
[units: Percentage of Participants]
  21.3  


Statistical Analysis 1 for Percentage of Participants With Treatment Failure Through Week 48
Groups [1] Atazanavir (ATV)/Ritonavir (RTV) Monotherapy
Method [2] exact binomial methods
Percentage of Participants [3] 21.3
95% Confidence Interval ( 11.9 to 33.7 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Given the small sample size, the 95% confidence interval is made with exact binomial methods.
[3] Other relevant estimation information:
  No text entered.



2.  Secondary:   Percentage of Participants With Treatment Failure Through Week 96   [ Time Frame: Week 96 ]

Measure Type Secondary
Measure Title Percentage of Participants With Treatment Failure Through Week 96
Measure Description Treatment Failure through Week 96 defined as virologic rebound (HIV RNA >=400 c/mL) on or before Week 96 or study discontinuation before Week 96. In addition, treatment failure defined based on HIV RNA >= 50 c/mL, latter analysis performed on treated subjects with baseline HIV RNA < 50 c/mL.
Time Frame Week 96  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated participants. For the second row (n=60), one subject was excluded because of baseline HIV RNA > 50 c/mL.

Reporting Groups
  Description
Atazanavir (ATV)/Ritonavir (RTV) Monotherapy ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)

Measured Values
    Atazanavir (ATV)/Ritonavir (RTV) Monotherapy  
Number of Participants Analyzed  
[units: participants]
  61  
Percentage of Participants With Treatment Failure Through Week 96  
[units: percentage of participants]
 
HIV RNA >= 400 c/mL(n=61)     34.4  
HIV RNA>=50 c/mL w/Baseline HIV RNA<50 c/mL (n=60)     43.3  


Statistical Analysis 1 for Percentage of Participants With Treatment Failure Through Week 96
Groups [1] Atazanavir (ATV)/Ritonavir (RTV) Monotherapy
Method [2] exact binomial methods
Percentage of Participants [3] 34.4
95% Confidence Interval ( 22.7 to 47.7 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Given the small sample size, the 95% confidence interval is made with exact binomial methods.
[3] Other relevant estimation information:
  No text entered.



3.  Secondary:   Percentage of Participants With Virological Rebound Through Week 48   [ Time Frame: Week 48 ]

Measure Type Secondary
Measure Title Percentage of Participants With Virological Rebound Through Week 48
Measure Description Virological rebound is defined as confirmed on-treatment HIV RNA >= 400 c/mL at 2 consecutive visits or last on-treatment HIV RNA >=400 c/mL followed by discontinuation of study therapy. In addition, virologic rebound defined based on HIV RNA >=50 c/m, latter analysis performed on subjects with baseline HIV RNA < 50 c/mL.
Time Frame Week 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated participants. For the second row (n=60), one subject was excluded because of baseline HIV RNA > 50 c/mL.

Reporting Groups
  Description
Atazanavir (ATV)/Ritonavir (RTV) Monotherapy ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)

Measured Values
    Atazanavir (ATV)/Ritonavir (RTV) Monotherapy  
Number of Participants Analyzed  
[units: participants]
  61  
Percentage of Participants With Virological Rebound Through Week 48  
[units: percentage of participants]
 
HIV RNA >= 400 c/mL (n=61)     12  
HIV RNA>=50 c/mL w/Baseline HIV RNA<50 c/mL (n=60)     26.7  

No statistical analysis provided for Percentage of Participants With Virological Rebound Through Week 48



4.  Secondary:   Percentage of Participants With Virological Rebound Through Week 96   [ Time Frame: Week 96 ]

Measure Type Secondary
Measure Title Percentage of Participants With Virological Rebound Through Week 96
Measure Description Virological rebound is defined as confirmed on-treatment HIV RNA >= 400 c/mL at 2 consecutive visits or last on-treatment HIV RNA >=400 c/mL followed by discontinuation of study therapy. In addition, virologic rebound defined based on HIV RNA >=50 c/m, latter analysis performed on subjects with baseline HIV RNA < 50 c/mL.
Time Frame Week 96  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated participants. For the second row (n=60), one subject was excluded because of baseline HIV RNA > 50 c/mL.

Reporting Groups
  Description
Atazanavir (ATV)/Ritonavir (RTV) Monotherapy ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)

Measured Values
    Atazanavir (ATV)/Ritonavir (RTV) Monotherapy  
Number of Participants Analyzed  
[units: participants]
  61  
Percentage of Participants With Virological Rebound Through Week 96  
[units: percentage of participants]
 
HIV RNA >= 400 c/mL (n=61)     14.8  
HIV RNA>=50 c/mL w/Baseline HIV RNA<50 c/mL (n=60)     33.3  

No statistical analysis provided for Percentage of Participants With Virological Rebound Through Week 96



5.  Secondary:   Cumulative Proportion of Participants Without Treatment Failure Through Week 100   [ Time Frame: Through Week 100 ]

Measure Type Secondary
Measure Title Cumulative Proportion of Participants Without Treatment Failure Through Week 100
Measure Description This Kaplan-Meier life table reports the cumulative proportion of participants without treatment failure up to the end of the respective time interval. Failure time is measured from the start of study therapy, and is based on the earliest event defining failure (virologic rebound at or before Week 96, or discontinuation prior to Week 96).
Time Frame Through Week 100  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
treated participants; n= the number at risk entering interval

Reporting Groups
  Description
Proportion of Participants Proportion of participants without treatment failure at the end of interval

Measured Values
    Proportion of Participants  
Number of Participants Analyzed  
[units: participants]
  61  
Cumulative Proportion of Participants Without Treatment Failure Through Week 100  
[units: proportion of participants]
 
Interval Week 4 - 8 (n=61)     0.9836  
Interval Week 8 - 12 (n=60)     0.9508  
Interval Week 12 - 16 (n=58)     0.9016  
Interval Week 16 - 20 (n=55)     0.8852  
Interval Week 20 - 24 (n=54)     0.8689  
Interval Week 24 - 28 (n=53)     0.8525  
Interval Week 32 - 36 (n=52)     0.8197  
Interval Week 36 - 40 (n=50)     0.7869  
Interval Week 48 - 52 (n=48)     0.7541  
Interval Week 56 - 60 (n=46)     0.7377  
Interval Week 64 - 68 (n=45)     0.7049  
Interval Week 68 - 72 (n=43)     0.6885  
Interval Week 72 - 76 (n=42)     0.6721  
Interval Week 84 - 88 (n=41)     0.6557  
Interval Week 92 - 96 (n=40)     0.6557  
Interval Week 96 - 100 (n=31)     0.6557  

No statistical analysis provided for Cumulative Proportion of Participants Without Treatment Failure Through Week 100



6.  Secondary:   Proportion of Participants With Virologic Rebound Through Week 96   [ Time Frame: Through Week 96 ]

Measure Type Secondary
Measure Title Proportion of Participants With Virologic Rebound Through Week 96
Measure Description Virologic rebound is defined as confirmed on-study HIV RNA ≥ 400 c/mL or last on-study HIV RNA ≥ 400 c/mL followed by treatment discontinuation.
Time Frame Through Week 96  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
This analysis was not done; however, percentage of participants with virologic rebound through Weeks 48 and 96 are reported in Secondary Outcome Measures 3 and 4. Time to reatment failure (defined as the earlier of virologic rebound or treatment discontinuation) is reported in Secondary Outcome Measure 5.

Reporting Groups
  Description
Proportion of Participants Proportion of participants without virologic rebound at the end of interval

Measured Values
    Proportion of Participants  
Number of Participants Analyzed  
[units: participants]
  0  
Proportion of Participants With Virologic Rebound Through Week 96  
[units: proportion of participants]
   

No statistical analysis provided for Proportion of Participants With Virologic Rebound Through Week 96



7.  Secondary:   Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 24   [ Time Frame: Baseline, Week 24 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 24
Measure Description No text entered.
Time Frame Baseline, Week 24  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
n=number of participants with CD4 cell count at baseline and at Week 24

Reporting Groups
  Description
Atazanavir (ATV)/Ritonavir (RTV) Monotherapy. ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)

Measured Values
    Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.  
Number of Participants Analyzed  
[units: participants]
  61  
Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 24  
[units: cells /mm3]
Mean ± Standard Deviation
 
Baseline Value (n=61)     559  ± 272.8  
Change at Week 24 (n=51)     61  ± 173.3  


Statistical Analysis 1 for Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 24
Groups [1] Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.
Method [2] normal approximation for 95% CI
Mean Change (Final Values) [3] 61
Standard Error of the mean ± 24.3
95% Confidence Interval ( 12.3 to 109.8 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  No text entered.



8.  Secondary:   Mean Change From Baseline in CD4 Cell Count at Week 48   [ Time Frame: Baseline, Week 48 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in CD4 Cell Count at Week 48
Measure Description No text entered.
Time Frame Baseline, Week 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
n=number of participants with CD4 cell count at baseline and at Week 48.

Reporting Groups
  Description
Atazanavir (ATV)/Ritonavir (RTV) Monotherapy. ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)

Measured Values
    Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.  
Number of Participants Analyzed  
[units: participants]
  61  
Mean Change From Baseline in CD4 Cell Count at Week 48  
[units: cells /mm3]
Mean ± Standard Deviation
 
Baseline Value (n=61)     559  ± 272.8  
Change at Week 48 (n=46)     53  ± 203.5  


Statistical Analysis 1 for Mean Change From Baseline in CD4 Cell Count at Week 48
Groups [1] Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.
Method [2] normal approximation for 95% CI
Mean Change (Final Values) [3] 53
Standard Error of the mean ± 30.0
95% Confidence Interval ( -7.1 to 113.7 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  No text entered.



9.  Secondary:   Mean Change From Baseline in CD4 Cell Count at Week 96   [ Time Frame: Baseline, Week 96 ]

Measure Type Secondary
Measure Title Mean Change From Baseline in CD4 Cell Count at Week 96
Measure Description No text entered.
Time Frame Baseline, Week 96  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
n=number of participants with CD4 cell count at baseline and at Week 96.

Reporting Groups
  Description
Atazanavir (ATV)/Ritonavir (RTV) Monotherapy. ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)

Measured Values
    Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.  
Number of Participants Analyzed  
[units: participants]
  61  
Mean Change From Baseline in CD4 Cell Count at Week 96  
[units: cells /mm3]
Mean ± Standard Deviation
 
Baseline Value (n=61)     559  ± 272.8  
Change at Week 96 (n=40)     63  ± 208.1  


Statistical Analysis 1 for Mean Change From Baseline in CD4 Cell Count at Week 96
Groups [1] Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.
Method [2] normal approximation for 95% CI
Mean Change (Final Values) [3] 63
Standard Error of the mean ± 32.9
95% Confidence Interval ( -4.0 to 129.1 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  No text entered.



10.  Secondary:   Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs   [ Time Frame: From Baseline through Week 96 ]

Measure Type Secondary
Measure Title Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs
Measure Description AE=any new untoward medical occurrence or worsening of a pre-existing medical condition that does not necessarily have a causal relationship to treatment. SAE=any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. AE grades are: mild (1), moderate (2), severe (3), life-threatening (4), and death (5).
Time Frame From Baseline through Week 96  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated Participants

Reporting Groups
  Description
Atazanavir (ATV)/Ritonavir (RTV) Monotherapy. ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)

Measured Values
    Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.  
Number of Participants Analyzed  
[units: participants]
  61  
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs  
[units: percentage of participants]
 
All Grades AEs     75.4  
All Grades AEs Related to Study Therapy     13.1  
Grade 3 to Grade 4 AEs     18  
Grade 3 to Grade 4 AEs Related to Study Therapy     3.3  
Deaths     3.3  
SAEs     19.7  
SAEs Related to Study Therapy     0  
AEs Leading to Discontinuation     4.9  
Lipodystrophy-Related AEs     1.6  

No statistical analysis provided for Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs



11.  Secondary:   Mean Percent Changes From Baseline in Fasting Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Non-HDL Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, and Triglycerides at Week 48   [ Time Frame: Baseline, Week 48 ]

Measure Type Secondary
Measure Title Mean Percent Changes From Baseline in Fasting Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Non-HDL Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, and Triglycerides at Week 48
Measure Description Lipid values after starting lipid-reducing agents are excluded from analyses. Baseline values are provided in Baseline Characteristics.
Time Frame Baseline, Week 48  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
n= number of treated participants with baseline measure and measure at Week 48

Reporting Groups
  Description
Atazanavir (ATV)/Ritonavir (RTV) Monotherapy. ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)

Measured Values
    Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.  
Number of Participants Analyzed  
[units: participants]
  61  
Mean Percent Changes From Baseline in Fasting Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Non-HDL Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, and Triglycerides at Week 48  
[units: percent change]
Mean ± Standard Deviation
 
Total Cholesterol (n=36)     9  ± 18.0  
HDL Cholesterol (n=35)     2  ± 18.5  
Non-HDL Cholesterol (n=35)     12  ± 24.4  
LDL Cholesterol (n=33)     20  ± 33.4  
Triglycerides (n=36)     17  ± 51.4  


Statistical Analysis 1 for Mean Percent Changes From Baseline in Fasting Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Non-HDL Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, and Triglycerides at Week 48
Groups [1] Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.
Method [2] normal approximation for 95% CI
Mean Change [3] 9
Standard Error of the mean ± 3.0
95% Confidence Interval ( 2.5 to 14.6 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Percent Change from Baseline in Fasting Total Cholesterol at Week 48
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Mean Percent Changes From Baseline in Fasting Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Non-HDL Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, and Triglycerides at Week 48
Groups [1] Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.
Method [2] normal approximation for 95% CI
Mean Change [3] 2
Standard Error of the mean ± 3.1
95% Confidence Interval ( -3.9 to 8.8 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Percent Change from Baseline in Fasting HDL Cholesterol at Week 48
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Mean Percent Changes From Baseline in Fasting Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Non-HDL Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, and Triglycerides at Week 48
Groups [1] Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.
Method [2] normal approximation for 95% CI
Mean Change [3] 12
Standard Error of the mean ± 4.1
95% Confidence Interval ( 4.0 to 20.8 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Percent Change from Baseline in Fasting Non-HDL Cholesterol at Week 48
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  No text entered.

Statistical Analysis 4 for Mean Percent Changes From Baseline in Fasting Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Non-HDL Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, and Triglycerides at Week 48
Groups [1] Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.
Method [2] normal approximation for 95% CI
Mean Change [3] 20
Standard Error of the mean ± 5.8
95% Confidence Interval ( 8.0 to 31.7 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Percent Change from Baseline in Fasting LDL Cholesterol at Week 48
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  No text entered.

Statistical Analysis 5 for Mean Percent Changes From Baseline in Fasting Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Non-HDL Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, and Triglycerides at Week 48
Groups [1] Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.
Method [2] normal approximation for 95% CI
Mean Change [3] 17
Standard Error of the mean ± 8.6
95% Confidence Interval ( -0.4 to 34.4 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Percent Change from Baseline in Fasting Triglycerides at Week 48
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  No text entered.



12.  Secondary:   Mean Percent Changes From Baseline in Fasting Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Non-HDL Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, and Triglycerides at Week 96   [ Time Frame: Baseline, Week 96 ]

Measure Type Secondary
Measure Title Mean Percent Changes From Baseline in Fasting Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Non-HDL Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, and Triglycerides at Week 96
Measure Description Lipid values after starting lipid-reducing agents are excluded from analyses. Baseline values are provided in Baseline Characteristics.
Time Frame Baseline, Week 96  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
n=number of treated participants with baseline measure and measure at Week 96

Reporting Groups
  Description
Atazanavir (ATV)/Ritonavir (RTV) Monotherapy. ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)

Measured Values
    Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.  
Number of Participants Analyzed  
[units: participants]
  61  
Mean Percent Changes From Baseline in Fasting Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Non-HDL Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, and Triglycerides at Week 96  
[units: percent change]
Mean ± Standard Deviation
 
Total Cholesterol (n=29)     14  ± 17.4  
HDL Cholesterol (n=29)     2  ± 21.2  
Non-HDL Cholesterol (n=29)     19  ± 23.7  
LDL Cholesterol (n=28)     29  ± 34.4  
Triglycerides (n=29)     16  ± 67.2  


Statistical Analysis 1 for Mean Percent Changes From Baseline in Fasting Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Non-HDL Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, and Triglycerides at Week 96
Groups [1] Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.
Method [2] normal approximation for 95% CI
Mean Change [3] 14
Standard Error of the mean ± 3.2
95% Confidence Interval ( 6.9 to 20.1 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Percent Change from Baseline in Fasting Total Cholesterol at Week 96
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Mean Percent Changes From Baseline in Fasting Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Non-HDL Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, and Triglycerides at Week 96
Groups [1] Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.
Method [2] normal approximation for 95% CI
Mean Change [3] 2
Standard Error of the mean ± 3.9
95% Confidence Interval ( -6.0 to 10.2 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Percent Change from Baseline in Fasting HDL Cholesterol at Week 96
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Mean Percent Changes From Baseline in Fasting Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Non-HDL Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, and Triglycerides at Week 96
Groups [1] Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.
Method [2] normal approximation for 95% CI
Mean Change [3] 19
Standard Error of the mean ± 4.4
95% Confidence Interval ( 10.3 to 28.4 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Percent Change from Baseline in Fasting Non-HDL Cholesterol at Week 96
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  No text entered.

Statistical Analysis 4 for Mean Percent Changes From Baseline in Fasting Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Non-HDL Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, and Triglycerides at Week 96
Groups [1] Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.
Method [2] normal approximation for 95% CI
Mean Change [3] 29
Standard Error of the mean ± 6.5
95% Confidence Interval ( 15.3 to 42.0 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Percent Change from Baseline in Fasting LDL Cholesterol at Week 96
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  No text entered.

Statistical Analysis 5 for Mean Percent Changes From Baseline in Fasting Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Non-HDL Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, and Triglycerides at Week 96
Groups [1] Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.
Method [2] normal approximation for 95% CI
Mean Change [3] 16
Standard Error of the mean ± 12.5
95% Confidence Interval ( -9.5 to 41.6 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Percent Change from Baseline in Fasting Triglycerides at Week 96
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Other relevant estimation information:
  No text entered.



13.  Secondary:   Number of Participants With Genotype Substitutions for Virologic Rebounds (HIV-RNA ≥ 400 c/mL) Through Week 48   [ Time Frame: Week 48 ]

Measure Type Secondary
Measure Title Number of Participants With Genotype Substitutions for Virologic Rebounds (HIV-RNA ≥ 400 c/mL) Through Week 48
Measure Description International Aids Society of the United States (IAS-USA)-defined major protease inhibitor (PI) substitutions are V32I, L33F, M46I/L, I47V, G48V, I50L/V, I54M/L, I76V, I82A/F/T/S, I84V, N88S, and L90M. Reverse Transcriptase (RT) are TAMS and M184V.
Time Frame Week 48  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Number of participants with virologic rebounds (HIV-RNA ≥ 400 c/mL) through Week 48.

Reporting Groups
  Description
Atazanavir (ATV)/Ritonavir (RTV) Monotherapy. ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)

Measured Values
    Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.  
Number of Participants Analyzed  
[units: participants]
  7  
Number of Participants With Genotype Substitutions for Virologic Rebounds (HIV-RNA ≥ 400 c/mL) Through Week 48  
[units: participants]
 
IAS-USA-defined major PI substitutions     1  
RT substitutions     0  

No statistical analysis provided for Number of Participants With Genotype Substitutions for Virologic Rebounds (HIV-RNA ≥ 400 c/mL) Through Week 48



14.  Secondary:   Number of Participants With Genotype Substitutions for Virologic Rebounds (HIV-RNA ≥ 400 c/mL) Through Week 96   [ Time Frame: Week 96 ]

Measure Type Secondary
Measure Title Number of Participants With Genotype Substitutions for Virologic Rebounds (HIV-RNA ≥ 400 c/mL) Through Week 96
Measure Description International Aids Society of the United States (IAS-USA)-defined major protease inhibitor (PI) substitutions are V32I, L33F, M46I/L, I47V, G48V, I50L/V, I54M/L, I76V, I82A/F/T/S, I84V, N88S, and L90M. Reverse Transcriptase (RT) are TAMS and M184V.
Time Frame Week 96  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Number of participants with virologic rebounds (HIV-RNA ≥ 400 c/mL) through Week 96.

Reporting Groups
  Description
Atazanavir (ATV)/Ritonavir (RTV) Monotherapy ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)

Measured Values
    Atazanavir (ATV)/Ritonavir (RTV) Monotherapy  
Number of Participants Analyzed  
[units: participants]
  9  
Number of Participants With Genotype Substitutions for Virologic Rebounds (HIV-RNA ≥ 400 c/mL) Through Week 96  
[units: participants]
 
IAS-USA-defined major PI substitutions     2  
RT substitutions     0  

No statistical analysis provided for Number of Participants With Genotype Substitutions for Virologic Rebounds (HIV-RNA ≥ 400 c/mL) Through Week 96




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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


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


No publications provided


Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00337467     History of Changes
Other Study ID Numbers: AI424-227
Study First Received: June 14, 2006
Results First Received: May 21, 2010
Last Updated: June 18, 2010
Health Authority: Spain: Spanish Agency of Medicines