Back to resultsAVX754 (a New Nucleoside Reverse Transcriptase Inhibitor [NRTI]) to Treat Drug-resistant HIV
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
AVX754
3TC
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Human Immunodeficiency Virus, anti-retroviral therapy, nucleoside analogue, reverse transcriptase, lamivudine, resistance mutation, Treatment Experienced
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
Sites / Locations
- Avexa (co-ordinating sites in Australia and Argentina)
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
600mg BID ATC
800mg BID ATC
150mg BID 3TC
Arm Description
600mg BID ATC
800mg BID ATC
150mg BID 3TC
Outcomes
Primary Outcome Measures
Change from baseline in HIV RNA levels at day 21
Time-weighted average change from baseline in HIV RNA levels through 21 days
Secondary Outcome Measures
Change from baseline in HIV RNA levels at days 7, 14, 21
Proportion of subjects with HIV RNA levels <400 or <50 at 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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00126880
Brief Title
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
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Avexa
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Human Immunodeficiency Virus, anti-retroviral therapy, nucleoside analogue, reverse transcriptase, lamivudine, resistance mutation, Treatment Experienced
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
600mg BID ATC
Arm Type
Experimental
Arm Description
600mg BID ATC
Arm Title
800mg BID ATC
Arm Type
Experimental
Arm Description
800mg BID ATC
Arm Title
150mg BID 3TC
Arm Type
Active Comparator
Arm Description
150mg BID 3TC
Intervention Type
Drug
Intervention Name(s)
AVX754
Other Intervention Name(s)
apricitabine
Intervention Description
apricitabine, 600mg BID or 800mg BID
Intervention Type
Drug
Intervention Name(s)
3TC
Other Intervention Name(s)
lamivudine
Intervention Description
3TC, 150mg BID
Primary Outcome Measure Information:
Title
Change from baseline in HIV RNA levels at day 21
Time Frame
day 21
Title
Time-weighted average change from baseline in HIV RNA levels through 21 days
Time Frame
21 days
Secondary Outcome Measure Information:
Title
Change from baseline in HIV RNA levels at days 7, 14, 21
Time Frame
days 7, 14, 21
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan W Cox, Ph D
Organizational Affiliation
Avexa
Official's Role
Study Director
Facility Information:
Facility Name
Avexa (co-ordinating sites in Australia and Argentina)
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3121
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
AVX754 (a New Nucleoside Reverse Transcriptase Inhibitor [NRTI]) to Treat Drug-resistant HIV
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