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; 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

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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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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

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1. Primary:

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

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2. Secondary:

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

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3. Secondary:

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

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4. Secondary:

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

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5. Secondary:

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

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6. Secondary:

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

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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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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.
Mean Change (Final Values) ^[2]	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 estimation information:
	No text entered.

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 ]

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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 ]

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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

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

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.

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

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