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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00126880
Recruitment Status : Completed
First Posted : August 5, 2005
Last Update Posted : June 23, 2011
Information provided by:

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.

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Study Type : Interventional  (Clinical Trial)
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 : July 2005
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Lamivudine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Change from baseline in HIV RNA levels at day 21 [ Time Frame: day 21 ]
  2. Time-weighted average change from baseline in HIV RNA levels through 21 days [ Time Frame: 21 days ]

Secondary Outcome Measures :
  1. Change from baseline in HIV RNA levels at days 7, 14, 21 [ Time Frame: days 7, 14, 21 ]
  2. 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 ]
  3. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00126880

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Australia, Victoria
Avexa (co-ordinating sites in Australia and Argentina)
Melbourne, Victoria, Australia, 3121
Sponsors and Collaborators
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Study Director: Susan W Cox, Ph D Avexa
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Responsible Party: Susan Cox, Avexa Identifier: NCT00126880    
Other Study ID Numbers: AVX-201
First Posted: August 5, 2005    Key Record Dates
Last Update Posted: June 23, 2011
Last Verified: June 2011
Keywords provided by Avexa:
Human Immunodeficiency Virus
anti-retroviral therapy
nucleoside analogue
reverse transcriptase
resistance mutation
Treatment Experienced
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents