AVX754 (nucleoside reverse transcriptase inhibitor) to treat drug resistant HIV
A Phase II, randomised, double-blinded, dose ranging study of AVX754 to reduce the viral load versus lamivudine in treatment experienced HIV-1 infected patients with the M184V mutation in reverse transcriptase.
Avexa Ltd
60 participants
Jun 7, 2005
Interventional
Conditions
Eligibility
Inclusion Criteria1
- Informed consentHIV-1 infectedM184V mutation in reverse transcriptaseCurrently taking lamivudineViral load >2,000 copies/mlCD4+ T-cell count>50 cells.
Exclusion Criteria1
- Hep B surface Antigen PositivePregnant or breast feeding femalesHepatitis C RNA positive requiring treatment.
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Interventions
600mg or 800mg AVX754 (a new drug treatment of HIV) for 48 weeks. This study is a phase IIb randomised, double-blind, multi-centre, dose-ranging, controlled parallel group study where lamivudine is the comparator. The study will enrol approximately 60 patients who will be followed for 48 weeks. The study will measure how safe and effective two doses of AVX754 (a new drug for the treatment of HIV) (600mg or 800mg) is compared to 150mg of lamivudine in treating HIV-1 infected people who have failed treatment with lamivudine.
Locations(1)
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ACTRN12605000742673