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

History of Changes

Results First Received: May 21, 2010

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

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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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

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Population Description

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

Age
[Units: Years]
Mean (Standard Deviation)

43 (9.5)

Gender
[Units: Participants]

Female

Male

Race/Ethnicity, Customized
[Units: Participants]

White

Cluster of Differentiation 4 (CD4) Categories
[Units: Participants]

CD4 Count <200 cells/mm3

CD4 Count >=200 cells/mm3

Human Immunodeficiency Ribonucleic Acid (HIV RNA) Categories
[Units: Participants]

HIV RNA <50 c/mL

HIV RNA >=50 c/mL

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

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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 ]

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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 ]

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8. Secondary:

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

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9. Secondary:

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

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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 ]

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12. Secondary:

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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 ]

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Serious Adverse Events

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Other Adverse Events