Clinical trial NCT00337467: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Human Immunodeficiency Virus (HIV) Infections
Keywords: HIV-Infected Patients Evidencing Virologic Suppression
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2006-06-16
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Percentage of Participants With Treatment Failure Through Week 48
timeFrame: Week 48
Secondary outcomes:
measure: Percentage of Participants With Treatment Failure Through Week 96
timeFrame: Week 96
measure: Percentage of Participants With Virological Rebound Through Week 48
timeFrame: Week 48
measure: Percentage of Participants With Virological Rebound Through Week 96
timeFrame: Week 96
measure: Cumulative Proportion of Participants Without Treatment Failure Through Week 100
timeFrame: Through Week 100
measure: Proportion of Participants With Virologic Rebound Through Week 96
timeFrame: Through Week 96
measure: Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 24
timeFrame: Baseline, Week 24
measure: Mean Change From Baseline in CD4 Cell Count at Week 48
timeFrame: Baseline, Week 48
measure: Mean Change From Baseline in CD4 Cell Count at Week 96
timeFrame: Baseline, Week 96
measure: Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs
timeFrame: From Baseline through Week 96
measure: 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
timeFrame: Baseline, Week 48
measure: 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
timeFrame: Baseline, Week 96
measure: Number of Participants With Genotype Substitutions for Virologic Rebounds (HIV-RNA ≥ 400 c/mL) Through Week 48
timeFrame: Week 48
measure: Number of Participants With Genotype Substitutions for Virologic Rebounds (HIV-RNA ≥ 400 c/mL) Through Week 96
timeFrame: Week 96
Other outcomes:
Locations:
city: Cordoba
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Malaga
country: Spain
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: