New Tablet Containing Two FDA Approved Anti-HIV Drugs For Antiretroviral Therapy Experienced HIV-1 Infected Subjects
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.
Human Immunodeficiency Virus I Infection
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||See Detailed Description|
- HIV viral load response as measured by change from baseline in HIV-1 RNA over 24 and 48 weeks. Safety [ Time Frame: 48 weeks ]
- Viral load response T-cell count Health Outcomes Resistance
|Study Start Date:||July 2002|
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.
Show 76 Study Locations
|Study Director:||GSK Clinical Trials, MD||GlaxoSmithKline|