AVX754 (a New Nucleoside Reverse Transcriptase Inhibitor [NRTI]) to Treat Drug-resistant HIV
- Registration Number
- NCT00126880
- Lead Sponsor
- Avexa
- Brief Summary
The study will measure how safe and effective AVX754 (a new drug for the treatment of HIV) is in treating HIV-1 infected people who have failed treatment with lamivudine.
- Detailed Description
Lamivudine or emtricitabine are commonly used in combination with other drugs for first-line treatment of HIV infection. Although effective initially, many people later on develop resistance to some or all of the drugs (including lamivudine) leading to virological failure. Resistance is associated with characteristic mutations, which for lamivudine is the M184V mutation. A change to new, active drugs must take place when patients fail their current regime, to regain control of the virus. Although there are other types of drugs available for second line treatment, there is currently no fully active, well tolerated cytidine analogue that can replace lamivudine in a second-line regimen when patients fail first line treatment. This study will measure the efficacy and safety of AVX754 (a novel cytidine analogue with activity against HIV resistant to other nucleosides) as part of a new regimen to treat patients who have failed treatment containing lamivudine, compared to the best alternative new regimen which continues to include lamivudine.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
- HIV-1 infected
- M184V mutation in reverse transcriptase
- Currently taking lamivudine
- Viral load >2000 copies/ml
- Hepatitis B surface antigen positive
- Pregnant or breastfeeding females
- Hepatitis C RNA positive and requiring treatment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 600mg BID ATC AVX754 600mg BID ATC 800mg BID ATC AVX754 800mg BID ATC 150mg BID 3TC 3TC 150mg BID 3TC
- Primary Outcome Measures
Name Time Method Change from baseline in HIV RNA levels at day 21 day 21 Time-weighted average change from baseline in HIV RNA levels through 21 days 21 days
- Secondary Outcome Measures
Name Time Method Proportion of subjects with HIV RNA levels <400 or <50 at days 7, 14, 21, and weeks 24 and 48 days 7, 14, 21, and weeks 24 and 48 Change from baseline in HIV RNA levels at days 7, 14, 21 days 7, 14, 21 Change from baseline and change in ratio of CD4+ and CD8+ cells at day 21 and weeks 24 and 48 day 21 and weeks 24 and 48
Trial Locations
- Locations (1)
Avexa (co-ordinating sites in Australia and Argentina)
🇦🇺Melbourne, Victoria, Australia