Clinical trial NCT00126880: AVX754 (a New Nucleoside Reverse Transcriptase Inhibitor [NRTI]) to Treat Drug-resistant HIV
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Keywords: Human Immunodeficiency Virus
anti-retroviral therapy
nucleoside analogue
reverse transcriptase
lamivudine
resistance mutation
Treatment Experienced
Lead sponsor: Avexa
Sponsor class: INDUSTRY
First posted: 2005-08-05
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change from baseline in HIV RNA levels at day 21
timeFrame: day 21
measure: Time-weighted average change from baseline in HIV RNA levels through 21 days
timeFrame: 21 days
Secondary outcomes:
measure: Change from baseline in HIV RNA levels at days 7, 14, 21
timeFrame: days 7, 14, 21
measure: Proportion of subjects with HIV RNA levels <400 or <50 at days 7, 14, 21, and weeks 24 and 48
timeFrame: days 7, 14, 21, and weeks 24 and 48
measure: Change from baseline and change in ratio of CD4+ and CD8+ cells at day 21 and weeks 24 and 48
timeFrame: day 21 and weeks 24 and 48
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Avexa (co-ordinating sites in Australia and Argentina)
state: Victoria
Study officials:
affiliation: Avexa
name: Susan W Cox, Ph D
role: STUDY_DIRECTOR
References: