Study of Boosted Atazanavir (ATV) Versus Non-boosted ATV in Naive Patients
- Conditions
- -B24 Unspecified human immunodeficiency virus [HIV] diseaseB24Unspecified human immunodeficiency virus [HIV] disease
- Registration Number
- PER-019-04
- Lead Sponsor
- BRISTOL MYERS SQUIBB COMPANY,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:HIV RNA levels<br>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).<br>Timepoints:48 week<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:not contemplated<br>Measure:not contemplated<br>Timepoints:not contemplated<br>