New Tablet Containing Two FDA Approved Anti-HIV Drugs For Antiretroviral Therapy Experienced HIV-1 Infected Subjects
Phase 3
Completed
- Conditions
- Infection, Human Immunodeficiency Virus IHIV Infection
- Registration Number
- NCT00044577
- Lead Sponsor
- ViiV Healthcare
- Brief Summary
A 48-week study to investigate the safety and effectiveness of a new compact formulation of two already FDA-approved anti-HIV drugs in subjects who have already been receiving treatment for their HIV infection.
- Detailed Description
A phase III, randomized, open-label, parallel, multicenter study to evaluate treatment with fixed-dose combination of abacavir/lamivudine (600mg/300mg) once-daily versus abacavir (300mg) twice-daily and lamivudine (300mg) once-daily in combination with tenofovir once-daily and a new PI or NNRTI for 48 weeks in ART-experienced HIV-1 infected patients.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 166
Inclusion Criteria
- Antiretroviral therapy (ART) experienced and currently receiving a stable regimen containing 3 nucleoside reverse transcriptase inhibitors (NRTIs), or 2 NRTIs plus a protease inhibitor (PI) or non-nucleoside reverse transcriptase inhibitors (NNRTI) for at least 3 months (there should be no significant ART modifications for at least 3 months and no ART change anticipated between Screening and initiation of the study therapy).
- Patients must be naive to tenofovir.
- HIV-1 RNA level > 1000 copies/ml on at least one occasion within 21 days of study entry.
- A CD4 cell count > 50 cells/mm3.
- Specified viral genotypes.
Exclusion Criteria
- Pregnant or breast-feeding women.
- Has an active diagnosis of AIDS.
- Additional qualifying criteria to be determined by the physician.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method HIV viral load response as measured by change from baseline in HIV-1 RNA over 24 and 48 weeks. Safety 48 weeks
- Secondary Outcome Measures
Name Time Method Viral load response T-cell count Health Outcomes Resistance
Trial Locations
- Locations (1)
GSK Investigational Site
🇬🇧London, United Kingdom