HIV-infected individuals
Conditions
Sponsors
Bristol-Myers Squibb International Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Written informed consent 2) Treatment naïve HIV-1 infected subjects ( =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the study. 2) Women who are pregnant or breastfeeding 3) Presence of a newly diagnosed HIV-related opportunistic infection or any medical condition requiring acute therapy at the time of enrollment 4) Primary HIV infection 5) Subjects with known Gilbert’s syndrome 6) Active alcohol or substance use sufficient, in the investigator’s opinion, to prevent adequate compliance with study therapy or to increase the risk of developing pancreatitis or chemical hepatitis 7) Screening laboratory values measured as follows: a) Grade IV glucose, b) Grade IV electrolytes, c) Grade IV transaminases, d) Grade IV hematology. 8) Hypersensitivity to any component of the formulation of study drug 9) Prior history of taking any ARV for more than 10 days 10) Concomitant administration of tenofovir (TDF). 11) Any other clinical conditions or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for study or unable to comply with the dosing requirements. 12) Prisoners or subjects who are compulsorily detained
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the proportion of subjects with HIV-1 RNA viral load < 50 c/mL through Week 48 of the Maintenance Phase among HIV-infected subjects with an initial undetectable viral load on an ATV/RTV containing HAART regimen, when switched to ATV versus remaining on ATV/RTV, whilst continuing their previous NRTI backbone.;Secondary Objective: For the Maintenance Phase, secondary objectives in subjects who switch to ATV alone compared to those who remain on ATV/RTV will be: • To assess the proportion of subjects with HIV RNA viral load < 400 c/mL through Week 48. • To assess time to treatment failure, defined as confirmed viral load (= 50 c/mL and = 400 c/mL) or study withdrawal. • To assess changes from baseline in CD4 cell count through Week 48. • To assess the safety of switching to an ATV containing regimen versus remaining on an ATV/RTV containing HAART regimen. For the Induction Phase, secondary objectives in subjects treated with ATV/RTV will be: • To describe the efficacy and safety of an ATV/RTV containing HAART regimen used for treatment induction, for randomized and non-randomized subjects. • To describe changes from baseline in CD4 cell count. • To describe changes in other exploratory immunological markers (e.g., CD8, CD45 cell counts) during treatment induction with ATV/RTV.;Primary end point(s): The primary endpoint measure will be the proportion of subjects with viral load < 50 c/mL through Week 48 of the Maintenance Phase between the 2 treatment arms. Secondary Endpoint Measures: • The proportions of subjects with a HIV-1 RNA viral load < 400 c/mL through the Maintenance Phase. • The time to treatment failure during the Maintenance Phase, defined as confirmed viral load ( = 50 c/mL and = 400 c/mL) or study withdrawal. • The changes from baseline in CD4 cell count through the Induction and Maintenance Phases. • The changes from baseline in fasting total cholesterol, LDL cholesterol, HDL cholesterol, non-HDL cholesterol and triglycerides | — |
Countries
Estonia, Germany, Ireland, Italy, Latvia, Spain, United Kingdom
Outcome results
None listed