RecruitingPhase 2ACTRN12605000742673

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.

Sponsor

Avexa Ltd

Enrollment

60 participants

Start Date

Jun 7, 2005

Study Type

Interventional

Conditions

HIV Infections

Eligibility

Sex: Both males and females

Plain Language Summary

Simplified for easier understanding

This study is testing a new antiretroviral medicine called AVX754 for people with HIV whose virus has developed resistance to a common HIV drug called lamivudine (3TC). When HIV develops resistance, treatment can stop working. This trial aims to see if AVX754 can be effective even when the virus has this specific resistance pattern (called M184V mutation). You may be eligible if: - You are HIV-1 positive - Your HIV virus has a specific resistance mutation called M184V in its reverse transcriptase gene - You are currently taking lamivudine (3TC) as part of your HIV treatment - Your viral load is above 2,000 copies per millilitre - Your CD4+ T-cell count is above 50 cells You may NOT be eligible if: - You are hepatitis B surface antigen positive - You are pregnant or breastfeeding (for women) - You have hepatitis C RNA that requires treatment Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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.