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
Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Human Immunodeficiency Virus (HIV) Infections
Intervention: Atazanavir + Ritonavir (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Bristol-Myers Squibb Official(s) and/or principal investigator(s): Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb
Summary
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.
Clinical Details
Official title: 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
Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Percentage of Participants With Treatment Failure Through Week 48
Secondary outcome: Percentage of Participants With Treatment Failure Through Week 96Percentage of Participants With Virological Rebound Through Week 48 Percentage of Participants With Virological Rebound Through Week 96 Cumulative Proportion of Participants Without Treatment Failure Through Week 100 Proportion of Participants With Virologic Rebound Through Week 96 Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 24 Mean Change From Baseline in CD4 Cell Count at Week 48 Mean Change From Baseline in CD4 Cell Count at Week 96 Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs 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 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 Number of Participants With Genotype Substitutions for Virologic Rebounds (HIV-RNA ≥ 400 c/mL) Through Week 48 Number of Participants With Genotype Substitutions for Virologic Rebounds (HIV-RNA ≥ 400 c/mL) Through Week 96
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Local Institution, Cordoba 14004, Spain
Local Institution, Madrid 28007, Spain
Local Institution, Madrid 28034, Spain
Local Institution, Madrid 28040, Spain
Local Institution, Madrid 28041, Spain
Local Institution, Madrid 28046, Spain
Local Institution, Malaga 29010, Spain
Additional Information
BMS Clinical Trials Disclosure For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm
Starting date: June 2006
Last updated: June 18, 2010
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