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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

  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

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. 
Overall Participants Analyzed 
[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) 
[1] Population analyzed = 54 (treated participants with baseline measure)
Fasting Low-Density Lipoprotein (LDL) Cholesterol [1] 
[Units: mg/dL]
Mean (Standard Deviation) 		 112  (52.3) 
[1] Population analyzed = 54 (treated participants with baseline measure)
Fasting Non-HDL Cholesterol [1] 
[Units: mg/dL]
Mean (Standard Deviation) 		 144  (57.9) 
[1] Population analyzed = 54 (treated participants with baseline measure)
Fasting Total Cholesterol [1] 
[Units: mg/dL]
Mean (Standard Deviation) 		 189  (57) 
[1] Population analyzed = 54 (treated participants with baseline measure)
Fasting Triglycerides [1] 
[Units: mg/dL]
Mean (Standard Deviation) 		 164  (95.7) 
[1] Population analyzed = 54 (treated participants with baseline measure)
HIV RNA 
[Units: Log10 c/mL]
Mean (Standard Deviation) 		 1.71  (0.152) 


  Outcome Measures

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

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

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

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

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

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  

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 
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 ]
  Show Outcome Measure 6

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

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

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

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 ]
  Show Outcome Measure 10

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 ]
  Show Outcome Measure 11

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 ]
  Show Outcome Measure 12

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

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


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.


  More Information