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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)

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ClinicalTrials.gov Identifier: NCT00337467
Recruitment Status : Completed
First Posted : June 16, 2006
Results First Posted : July 19, 2010
Last Update Posted : July 19, 2010
Sponsor:
Information provided by:
Bristol-Myers Squibb

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Human Immunodeficiency Virus (HIV) Infections
Intervention Drug: Atazanavir + Ritonavir
Enrollment 61
Recruitment Details  
Pre-assignment Details 63 participants were enrolled in this study; 2 were never treated (1 no longer met study criteria and 1 concomitant medication not permitted).
Arm/Group Title Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.
Hide Arm/Group Description 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)
Period Title: Overall Study
Started 61
Discontinued Prior to Week 96 10 [1]
Completed 51
Not Completed 10
Reason Not Completed
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
Arm/Group Title Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.
Hide Arm/Group Description 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)
Overall Number of Baseline Participants 61
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 61 participants
43  (9.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants
Female
15
  24.6%
Male
46
  75.4%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
White Number Analyzed 61 participants
61
Cluster of Differentiation 4 (CD4) Categories  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 61 participants
CD4 Count <200 cells/mm3 3
CD4 Count >=200 cells/mm3 58
Human Immunodeficiency Ribonucleic Acid (HIV RNA) Categories  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 61 participants
HIV RNA <50 c/mL 60
HIV RNA >=50 c/mL 1
CD4 Count  
Mean (Standard Deviation)
Unit of measure:  Cell/mm3
Number Analyzed 61 participants
559  (272.8)
Fasting High-Density Lipoprotein (HDL) Cholesterol   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 61 participants
45  (10.4)
[1]
Measure Description: Population analyzed = 54 (treated participants with baseline measure)
Fasting Low-Density Lipoprotein (LDL) Cholesterol   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 61 participants
112  (52.3)
[1]
Measure Description: Population analyzed = 54 (treated participants with baseline measure)
Fasting Non-HDL Cholesterol   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 61 participants
144  (57.9)
[1]
Measure Description: Population analyzed = 54 (treated participants with baseline measure)
Fasting Total Cholesterol   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 61 participants
189  (57)
[1]
Measure Description: Population analyzed = 54 (treated participants with baseline measure)
Fasting Triglycerides   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 61 participants
164  (95.7)
[1]
Measure Description: Population analyzed = 54 (treated participants with baseline measure)
HIV RNA  
Mean (Standard Deviation)
Unit of measure:  Log10 c/mL
Number Analyzed 61 participants
1.71  (0.152)
1.Primary Outcome
Title Percentage of Participants With Treatment Failure Through Week 48
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated participants
Arm/Group Title Atazanavir (ATV)/Ritonavir (RTV) Monotherapy
Hide Arm/Group Description:
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)
Overall Number of Participants Analyzed 61
Measure Type: Number
Unit of Measure: Percentage of Participants
21.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atazanavir (ATV)/Ritonavir (RTV) Monotherapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method exact binomial methods
Comments Given the small sample size, the 95% confidence interval is made with exact binomial methods.
Method of Estimation Estimation Parameter Percentage of Participants
Estimated Value 21.3
Confidence Interval (2-Sided) 95%
11.9 to 33.7
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With Treatment Failure Through Week 96
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated participants. For the second row (n=60), one subject was excluded because of baseline HIV RNA > 50 c/mL.
Arm/Group Title Atazanavir (ATV)/Ritonavir (RTV) Monotherapy
Hide Arm/Group Description:
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)
Overall Number of Participants Analyzed 61
Measure Type: Number
Unit of Measure: 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
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atazanavir (ATV)/Ritonavir (RTV) Monotherapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method exact binomial methods
Comments Given the small sample size, the 95% confidence interval is made with exact binomial methods.
Method of Estimation Estimation Parameter Percentage of Participants
Estimated Value 34.4
Confidence Interval (2-Sided) 95%
22.7 to 47.7
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants With Virological Rebound Through Week 48
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated participants. For the second row (n=60), one subject was excluded because of baseline HIV RNA > 50 c/mL.
Arm/Group Title Atazanavir (ATV)/Ritonavir (RTV) Monotherapy
Hide Arm/Group Description:
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)
Overall Number of Participants Analyzed 61
Measure Type: Number
Unit of Measure: 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
4.Secondary Outcome
Title Percentage of Participants With Virological Rebound Through Week 96
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated participants. For the second row (n=60), one subject was excluded because of baseline HIV RNA > 50 c/mL.
Arm/Group Title Atazanavir (ATV)/Ritonavir (RTV) Monotherapy
Hide Arm/Group Description:
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)
Overall Number of Participants Analyzed 61
Measure Type: Number
Unit of Measure: 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
5.Secondary Outcome
Title Cumulative Proportion of Participants Without Treatment Failure Through Week 100
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
treated participants; n= the number at risk entering interval
Arm/Group Title Proportion of Participants
Hide Arm/Group Description:
Proportion of participants without treatment failure at the end of interval
Overall Number of Participants Analyzed 61
Measure Type: Number
Unit of Measure: 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
6.Secondary Outcome
Title Proportion of Participants With Virologic Rebound Through Week 96
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Proportion of Participants
Hide Arm/Group Description:
Proportion of participants without virologic rebound at the end of interval
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 24
Hide Description [Not Specified]
Time Frame Baseline, Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
n=number of participants with CD4 cell count at baseline and at Week 24
Arm/Group Title Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.
Hide Arm/Group Description:
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)
Overall Number of Participants Analyzed 61
Mean (Standard Deviation)
Unit of Measure: cells /mm3
Baseline Value (n=61) 559  (272.8)
Change at Week 24 (n=51) 61  (173.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method normal approximation for 95% CI
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Change (Final Values)
Estimated Value 61
Confidence Interval (2-Sided) 95%
12.3 to 109.8
Parameter Dispersion
Type: Standard Error of the mean
Value: 24.3
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Mean Change From Baseline in CD4 Cell Count at Week 48
Hide Description [Not Specified]
Time Frame Baseline, Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
n=number of participants with CD4 cell count at baseline and at Week 48.
Arm/Group Title Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.
Hide Arm/Group Description:
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)
Overall Number of Participants Analyzed 61
Mean (Standard Deviation)
Unit of Measure: cells /mm3
Baseline Value (n=61) 559  (272.8)
Change at Week 48 (n=46) 53  (203.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method normal approximation for 95% CI
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Change (Final Values)
Estimated Value 53
Confidence Interval (2-Sided) 95%
-7.1 to 113.7
Parameter Dispersion
Type: Standard Error of the mean
Value: 30.0
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Mean Change From Baseline in CD4 Cell Count at Week 96
Hide Description [Not Specified]
Time Frame Baseline, Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
n=number of participants with CD4 cell count at baseline and at Week 96.
Arm/Group Title Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.
Hide Arm/Group Description:
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)
Overall Number of Participants Analyzed 61
Mean (Standard Deviation)
Unit of Measure: cells /mm3
Baseline Value (n=61) 559  (272.8)
Change at Week 96 (n=40) 63  (208.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method normal approximation for 95% CI
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Change (Final Values)
Estimated Value 63
Confidence Interval (2-Sided) 95%
-4.0 to 129.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 32.9
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated Participants
Arm/Group Title Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.
Hide Arm/Group Description:
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)
Overall Number of Participants Analyzed 61
Measure Type: Number
Unit of Measure: 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
11.Secondary Outcome
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
Hide Description Lipid values after starting lipid-reducing agents are excluded from analyses. Baseline values are provided in Baseline Characteristics.
Time Frame Baseline, Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
n= number of treated participants with baseline measure and measure at Week 48
Arm/Group Title Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.
Hide Arm/Group Description:
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)
Overall Number of Participants Analyzed 61
Mean (Standard Deviation)
Unit of Measure: percent change
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)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.
Comments Percent Change from Baseline in Fasting Total Cholesterol at Week 48
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method normal approximation for 95% CI
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Change
Estimated Value 9
Confidence Interval (2-Sided) 95%
2.5 to 14.6
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.0
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.
Comments Percent Change from Baseline in Fasting HDL Cholesterol at Week 48
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method normal approximation for 95% CI
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Change
Estimated Value 2
Confidence Interval (2-Sided) 95%
-3.9 to 8.8
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.1
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.
Comments Percent Change from Baseline in Fasting Non-HDL Cholesterol at Week 48
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method normal approximation for 95% CI
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Change
Estimated Value 12
Confidence Interval (2-Sided) 95%
4.0 to 20.8
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.1
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.
Comments Percent Change from Baseline in Fasting LDL Cholesterol at Week 48
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method normal approximation for 95% CI
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Change
Estimated Value 20
Confidence Interval (2-Sided) 95%
8.0 to 31.7
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.8
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.
Comments Percent Change from Baseline in Fasting Triglycerides at Week 48
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method normal approximation for 95% CI
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Change
Estimated Value 17
Confidence Interval (2-Sided) 95%
-0.4 to 34.4
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.6
Estimation Comments [Not Specified]
12.Secondary Outcome
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
Hide Description Lipid values after starting lipid-reducing agents are excluded from analyses. Baseline values are provided in Baseline Characteristics.
Time Frame Baseline, Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
n=number of treated participants with baseline measure and measure at Week 96
Arm/Group Title Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.
Hide Arm/Group Description:
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)
Overall Number of Participants Analyzed 61
Mean (Standard Deviation)
Unit of Measure: percent change
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)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.
Comments Percent Change from Baseline in Fasting Total Cholesterol at Week 96
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method normal approximation for 95% CI
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Change
Estimated Value 14
Confidence Interval 95%
6.9 to 20.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.2
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.
Comments Percent Change from Baseline in Fasting HDL Cholesterol at Week 96
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method normal approximation for 95% CI
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Change
Estimated Value 2
Confidence Interval (2-Sided) 95%
-6.0 to 10.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 3.9
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.
Comments Percent Change from Baseline in Fasting Non-HDL Cholesterol at Week 96
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method normal approximation for 95% CI
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Change
Estimated Value 19
Confidence Interval (2-Sided) 95%
10.3 to 28.4
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.4
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.
Comments Percent Change from Baseline in Fasting LDL Cholesterol at Week 96
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method normal approximation for 95% CI
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Change
Estimated Value 29
Confidence Interval (2-Sided) 95%
15.3 to 42.0
Parameter Dispersion
Type: Standard Error of the mean
Value: 6.5
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.
Comments Percent Change from Baseline in Fasting Triglycerides at Week 96
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method normal approximation for 95% CI
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Change
Estimated Value 16
Confidence Interval (2-Sided) 95%
-9.5 to 41.6
Parameter Dispersion
Type: Standard Error of the mean
Value: 12.5
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Number of Participants With Genotype Substitutions for Virologic Rebounds (HIV-RNA ≥ 400 c/mL) Through Week 48
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of participants with virologic rebounds (HIV-RNA ≥ 400 c/mL) through Week 48.
Arm/Group Title Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.
Hide Arm/Group Description:
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)
Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: participants
IAS-USA-defined major PI substitutions 1
RT substitutions 0
14.Secondary Outcome
Title Number of Participants With Genotype Substitutions for Virologic Rebounds (HIV-RNA ≥ 400 c/mL) Through Week 96
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of participants with virologic rebounds (HIV-RNA ≥ 400 c/mL) through Week 96.
Arm/Group Title Atazanavir (ATV)/Ritonavir (RTV) Monotherapy
Hide Arm/Group Description:
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)
Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: participants
IAS-USA-defined major PI substitutions 2
RT substitutions 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ATV/RTV Monotherapy
Hide Arm/Group Description 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)
All-Cause Mortality
ATV/RTV Monotherapy
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
ATV/RTV Monotherapy
Affected / at Risk (%)
Total   12/61 (19.67%) 
General disorders   
MULTI-ORGAN FAILURE  1  1/61 (1.64%) 
Infections and infestations   
SEPSIS  1  1/61 (1.64%) 
PNEUMONIA  1  2/61 (3.28%) 
APPENDICITIS  1  1/61 (1.64%) 
EYE INFECTION SYPHILITIC  1  1/61 (1.64%) 
Injury, poisoning and procedural complications   
ACCIDENT  1  1/61 (1.64%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
BLADDER CANCER  1  1/61 (1.64%) 
Nervous system disorders   
HEADACHE  1  1/61 (1.64%) 
ISCHAEMIC STROKE  1  1/61 (1.64%) 
Psychiatric disorders   
SUICIDAL IDEATION  1  1/61 (1.64%) 
DYSTHYMIC DISORDER  1  1/61 (1.64%) 
PSYCHOTIC DISORDER  1  1/61 (1.64%) 
DEPRESSION SUICIDAL  1  1/61 (1.64%) 
Reproductive system and breast disorders   
TESTICULAR ATROPHY  1  1/61 (1.64%) 
Vascular disorders   
PERIPHERAL ISCHAEMIA  1  1/61 (1.64%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ATV/RTV Monotherapy
Affected / at Risk (%)
Total   25/61 (40.98%) 
Infections and infestations   
TOOTH INFECTION  1  4/61 (6.56%) 
RESPIRATORY TRACT INFECTION  1  5/61 (8.20%) 
Metabolism and nutrition disorders   
HYPERCHOLESTEROLAEMIA  1  7/61 (11.48%) 
HYPERTRIGLYCERIDAEMIA  1  6/61 (9.84%) 
Nervous system disorders   
HEADACHE  1  5/61 (8.20%) 
Psychiatric disorders   
DEPRESSION  1  4/61 (6.56%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
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.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Results Point of Contact
Name/Title: BMS Study Director
Organization: Bristol-Myers Squibb
Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00337467     History of Changes
Other Study ID Numbers: AI424-227
First Submitted: June 14, 2006
First Posted: June 16, 2006
Results First Submitted: May 21, 2010
Results First Posted: July 19, 2010
Last Update Posted: July 19, 2010