None listed
Conditions
Interventions
Drug: Atazanavir/ Stavidine / Lamivudine Type of group
Capsules, Oral, ATV (2 x 200 mg) QD + 3TC (2 x 150 mg) QD + Zerit XR (1 x 100 mg) QD, Once daily, 96 weeks.
Group name:Drug: Atazanavir-Ritonavir/ Stavidine / Lamivudine Type of group
Capsules, Oral, ATV (2 x 150 mg) QD + RTV (1 x 100 mg) QD + 3TC (2 x 150 mg) QD + Zerit XR (1 x 100 mg) QD*, Once daily, 96 weeks.
Sponsors
BRISTOL MYERS SQUIBB COMPANY,
Eligibility
Inclusion criteria
Inclusion criteria: Signed Informed Consent HIV RNA greater than or equal 200 copies/mL at screening 18 years old or older Must use barrier contraception Women of child-bearing potential must have a negative serum or urine pregnancy test within 72 hours before beginning to take the study medications
Exclusion criteria
Exclusion criteria: Unable or unwilling to use acceptable method of birth control for the entire study period including 8 weeks after the study Women using oral contraceptives, pregnant or breastfeeding women Women who have a positive pregnancy test on enrollment or before beginning to take the study medications People who have a life expectancy of greater than 12 months Newly diagnosed HIV-related OI or any medical condition requiring acute therapy at the time of enrollment Any antiretroviral therapy within 30 days prior to screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:HIV RNA levels Measure:To compare the proportion of subjects responding to treatment with HIV RNA levels < LOQ (400 c/mL) through Week 48 in treatment naive subjects for ATV and ATV/RTV (each combined with 3TC and d4T XR). Timepoints:48 week | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:not contemplated Measure:not contemplated Timepoints:not contemplated | — |
Countries
Peru, United States
Outcome results
None listed