Study Of Investigational Regimen Combining FDA Approved HIV Drugs In HIV Subjects Experiencing Early Virologic Failure
Phase 4
Completed
- Conditions
- HIV Infection
- Registration Number
- NCT00038506
- Lead Sponsor
- ViiV Healthcare
- Brief Summary
This study is a 48-week study to evaluate the efficacy and safety of an investigational regimen combining FDA approved HIV drugs in antiretroviral-experienced subjects failing on their first highly active antiretroviral therapy regimen.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
- Currently on an initial HAART (highly active antiretroviral therapy) regimen of 3TC/ZDV or 3TC/d4T and a PI (protease inhibitor) -boosted or unboosted- or NNRTI (non-nucleoside reverse transcriptase inhibitor).
- Plasma HIV - 1 RNA was <400 copies/ml on at least 2 documented occasions prior to viral rebound.
- Have a plasma HIV - 1 RNA value >400 copies/ml and <10,000 copies/ml on 2 documented successive occasions (including screen) separated by at least 2 weeks.
- A CD4+ lymphocyte count less than or equal to 100.
Exclusion Criteria
- Have not taken Abacavir (ZIAGEN or TRIZIVIR) or tenofovir (VIREAD) previously.
- Have not had an AIDS defining illness within 30 days of screen.
- Pregnant or breast-feeding.
- Specified viral genotypes upon screening.
- And other inclusion or exclusion criteria to be evaluated by the physician.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method HIV viral load response at 48 weeks as measured by proportion of subjects with undetectable viral load. 48 weeks
- Secondary Outcome Measures
Name Time Method Safety Viral load response at 24 weeks Change in T-cell count Resistance Health outcomes 24 weeks
Trial Locations
- Locations (1)
GSK Investigational Site
🇺🇸Green Bay, Wisconsin, United States