AVX754 (a New Nucleoside Reverse Transcriptase Inhibitor [NRTI]) to Treat Drug-resistant HIV

Sponsor

Avexa (Industry)

Overall Status

Completed

CT.gov ID

NCT00126880

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: AVX754 Drug: 3TC	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

52 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

Jul 1, 2005

Actual Primary Completion Date :

Jan 1, 2008

Actual Study Completion Date :

Jan 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 600mg BID ATC 600mg BID ATC	Drug: AVX754 apricitabine, 600mg BID or 800mg BID Other Names: apricitabine
Experimental: 800mg BID ATC 800mg BID ATC	Drug: AVX754 apricitabine, 600mg BID or 800mg BID Other Names: apricitabine
Active Comparator: 150mg BID 3TC 150mg BID 3TC	Drug: 3TC 3TC, 150mg BID Other Names: lamivudine

Arm

Intervention/Treatment

Experimental: 600mg BID ATC

600mg BID ATC

Drug: AVX754

apricitabine, 600mg BID or 800mg BID

Other Names:

apricitabine

Experimental: 800mg BID ATC

800mg BID ATC

Drug: AVX754

apricitabine, 600mg BID or 800mg BID

Other Names:

apricitabine

Active Comparator: 150mg BID 3TC

150mg BID 3TC

Drug: 3TC

3TC, 150mg BID

Other Names:

lamivudine

Outcome Measures

Primary Outcome Measures

Change from baseline in HIV RNA levels at day 21 [day 21]
Time-weighted average change from baseline in HIV RNA levels through 21 days [21 days]

Secondary Outcome Measures

Change from baseline in HIV RNA levels at days 7, 14, 21 [days 7, 14, 21]
Proportion of subjects with HIV RNA levels <400 or <50 at days 7, 14, 21, and weeks 24 and 48 [days 7, 14, 21, and weeks 24 and 48]
Change from baseline and change in ratio of CD4+ and CD8+ cells at day 21 and weeks 24 and 48 [day 21 and weeks 24 and 48]