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
  Purpose

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 Intervention Phase
HIV Infections
Drug: AVX754
Drug: 3TC
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Avexa:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 52
Study Start Date: July 2005
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 600mg BID ATC
600mg BID ATC
Drug: AVX754
apricitabine, 600mg BID or 800mg BID
Other Name: apricitabine
Experimental: 800mg BID ATC
800mg BID ATC
Drug: AVX754
apricitabine, 600mg BID or 800mg BID
Other Name: apricitabine
Active Comparator: 150mg BID 3TC
150mg BID 3TC
Drug: 3TC
3TC, 150mg BID
Other Name: 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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00126880

Locations
Australia, Victoria
Avexa (co-ordinating sites in Australia and Argentina)
Melbourne, Victoria, Australia, 3121
Sponsors and Collaborators
Avexa
Investigators
Study Director: Susan W Cox, Ph D Avexa
  More Information

No publications provided

Responsible Party: Susan Cox, Avexa
ClinicalTrials.gov Identifier: NCT00126880     History of Changes
Other Study ID Numbers: AVX-201
Study First Received: August 3, 2005
Last Updated: June 22, 2011
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by Avexa:
Human Immunodeficiency Virus
anti-retroviral therapy
nucleoside analogue
reverse transcriptase
lamivudine
resistance mutation
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Lamivudine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on April 16, 2014