Trial | NCT00126880  Report issue

Title

AVX754 (a New Nucleoside Reverse Transcriptase Inhibitor [NRTI]) to Treat Drug-resistant HIV
A Phase II, Randomised, Double-blind, Dose-ranging Study of AVX754 Versus Lamivudine in Treatment-experienced HIV-1 Infected Patients With the M184V Mutation in Reverse Transcriptase

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    52
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.
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.
Study Started
Jul 31
2005
Primary Completion
Jan 31
2008
Study Completion
Jan 31
2008
Last Update
Jun 23
2011
Estimate

Drug AVX754

apricitabine, 600mg BID or 800mg BID

  • Other names: apricitabine

Drug 3TC

3TC, 150mg BID

  • Other names: lamivudine

600mg BID ATC Experimental

600mg BID ATC

800mg BID ATC Experimental

800mg BID ATC

150mg BID 3TC Active Comparator

150mg BID 3TC

Criteria 

Inclusion Criteria:

HIV-1 infected
M184V mutation in reverse transcriptase
Currently taking lamivudine
Viral load >2000 copies/ml

Exclusion Criteria:

Hepatitis B surface antigen positive
Pregnant or breastfeeding females
Hepatitis C RNA positive and requiring treatment
No Results Posted