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.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000742673

Acronym

AVX-201

Enrollment

Registered

2005-11-15

Start date

2005-06-07

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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 fail

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

Inclusion criteria

Informed consentHIV-1 infectedM184V mutation in reverse transcriptaseCurrently taking lamivudineViral load >2,000 copies/mlCD4+ T-cell count>50 cells.

Exclusion criteria

Hep B surface Antigen PositivePregnant or breast feeding femalesHepatitis C RNA positive requiring treatment.

Outcome results