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

This study has been completed.
Sponsor:
Information provided by:
Avexa
ClinicalTrials.gov Identifier:
NCT00126880
First received: August 3, 2005
Last updated: June 22, 2011
Last verified: June 2011

August 3, 2005
June 22, 2011
July 2005
January 2008   (final data collection date for primary outcome measure)
  • Change from baseline in HIV RNA levels at day 21 [ Time Frame: day 21 ] [ Designated as safety issue: No ]
  • Time-weighted average change from baseline in HIV RNA levels through 21 days [ Time Frame: 21 days ] [ Designated as safety issue: No ]
  • Change from baseline in HIV RNA levels at day 21
  • Time-weighted average change from baseline in HIV RNA levels through 21 days
Complete list of historical versions of study NCT00126880 on ClinicalTrials.gov Archive Site
  • Change from baseline in HIV RNA levels at days 7, 14, 21 [ Time Frame: days 7, 14, 21 ] [ Designated as safety issue: No ]
  • Proportion of subjects with HIV RNA levels <400 or <50 at days 7, 14, 21, and weeks 24 and 48 [ Time Frame: days 7, 14, 21, and weeks 24 and 48 ] [ Designated as safety issue: No ]
  • Change from baseline and change in ratio of CD4+ and CD8+ cells at day 21 and weeks 24 and 48 [ Time Frame: day 21 and weeks 24 and 48 ] [ Designated as safety issue: No ]
  • Change from baseline in HIV RNA levels at day 7, 14, 21
  • Proportion of subjects with HIV RNA levels <400 or <50 at day 7, 14, 21, week 24 and week 48
  • Change from baseline and change in ratio of CD4+ and CD8+ cells at day 21, week 24 and week 48
Not Provided
Not Provided
 
AVX754 (a New Nucleoside Reverse Transcriptase Inhibitor [NRTI]) to Treat Drug-resistant HIV
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
HIV Infections
  • Drug: AVX754
    apricitabine, 600mg BID or 800mg BID
    Other Name: apricitabine
  • Drug: 3TC
    3TC, 150mg BID
    Other Name: lamivudine
  • Experimental: 600mg BID ATC
    600mg BID ATC
    Intervention: Drug: AVX754
  • Experimental: 800mg BID ATC
    800mg BID ATC
    Intervention: Drug: AVX754
  • Active Comparator: 150mg BID 3TC
    150mg BID 3TC
    Intervention: Drug: 3TC
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
January 2008
January 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00126880
AVX-201
Yes
Susan Cox, Avexa
Avexa
Not Provided
Study Director: Susan W Cox, Ph D Avexa
Avexa
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP