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

June 14, 2006
June 18, 2010
June 2006
May 2008   (final data collection date for primary outcome measure)
Percentage of Participants With Treatment Failure Through Week 48 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
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.
Rate of subjects with viral rebound > 400 c or disontinuealtion at W48
Complete list of historical versions of study NCT00337467 on ClinicalTrials.gov Archive Site
  • Percentage of Participants With Treatment Failure Through Week 96 [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
    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.
  • Percentage of Participants With Virological Rebound Through Week 48 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    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.
  • Percentage of Participants With Virological Rebound Through Week 96 [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
    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.
  • Cumulative Proportion of Participants Without Treatment Failure Through Week 100 [ Time Frame: Through Week 100 ] [ Designated as safety issue: No ]
    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).
  • Proportion of Participants With Virologic Rebound Through Week 96 [ Time Frame: Through Week 96 ] [ Designated as safety issue: No ]
    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.
  • Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 24 [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline in CD4 Cell Count at Week 48 [ Time Frame: Baseline, Week 48 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline in CD4 Cell Count at Week 96 [ Time Frame: Baseline, Week 96 ] [ Designated as safety issue: No ]
  • Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs [ Time Frame: From Baseline through Week 96 ] [ Designated as safety issue: Yes ]
    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).
  • 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 ] [ Designated as safety issue: Yes ]
    Lipid values after starting lipid-reducing agents are excluded from analyses. Baseline values are provided in Baseline Characteristics.
  • 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 ] [ Designated as safety issue: Yes ]
    Lipid values after starting lipid-reducing agents are excluded from analyses. Baseline values are provided in Baseline Characteristics.
  • Number of Participants With Genotype Substitutions for Virologic Rebounds (HIV-RNA ≥ 400 c/mL) Through Week 48 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
    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.
  • Number of Participants With Genotype Substitutions for Virologic Rebounds (HIV-RNA ≥ 400 c/mL) Through Week 96 [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
    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.
Proportion of viral rebounds >50 c at W48, Time to treatment failure, Time to rebound, CD4 Change from baseline to W48, Safety maintenance and Resistance, Incidence to ATV/RTV in Monotherapy
Not Provided
Not Provided
 
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
Phase IIIb Multicenter, Single Arm, Open-Label Pilot Study to Evaluate the Effectiveness and Safety of Maintenance With Atazanavir/Ritonavir as Single Enhanced Protease Inhibitor Therapy in HIV-Infected Patients Evidencing Virologic Suppression OREY (Only REYataz) Study

The main purpose is to explore whether atazanavir/ritonavir (ATV/RTV) single enhanced protease inhibitor therapy can maintain virologic suppression without a marked increase in virologic failure.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Human Immunodeficiency Virus (HIV) Infections
Drug: Atazanavir + Ritonavir
Capsules, Oral, ATV 300mg + RTV 100mg, once daily, 96 weeks
Other Names:
  • Reyataz
  • BMS-232632
Experimental: A1
Intervention: Drug: Atazanavir + Ritonavir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
61
May 2009
May 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • On continued antiretroviral (ARV) treatment, with no discontinuation periods, for the previous 6 months (24 weeks).
  • Absence of evidence or suspected virologic failure on antiretroviral therapy
  • Absence of known primary mutations in the protease gene
  • Only 1 highly active antiretroviral therapy (HAART) prior to current one
  • HIV RNA < 50 copies/mL in the last 6 months (single blip below 200 c/mL allowed)
  • On ATV/RTV +2 nucleoside reverse transcriptase inhibitors (NRTIs) (or 1 NRTI + tenofovir [TDF]) for at least 8 weeks before study entry, without treatment-limiting adverse effects

Exclusion Criteria:

  • Presence of a newly diagnosed HIV-related opportunistic infection or any medical condition requiring acute therapy at the time of enrollment.
  • Active disease condition (e.g. moderate to severe hepatic impairment/active renal disease/history of clinically significant heart conduction disease)
  • Patients with chronic hepatitis B receiving lamivudine (3TC), Tenofovir Disoproxil Fumarate (TDF) or emtricitabine (FTC).
  • CD4 < 100 cells/mm3
  • Grade IV laboratory values: Hemoglobin < 6.5 g/dL or white blood cells (WBC) <800/mmm3 or absolute neutrophil count < 500/mm3, or platelets < 20,000/mm3 or diffuse petechiae.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00337467
AI424-227
No
Study Director, Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP