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

A

Avexa

Status and phase

Completed
Phase 2

Conditions

HIV Infections

Treatments

Drug: AVX754
Drug: 3TC

Study type

Interventional

Funder types

Industry

Identifiers

NCT00126880
AVX-201

Details and patient eligibility

About

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.

Full 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.

Enrollment

52 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

52 participants in 3 patient groups

600mg BID ATC
Experimental group
Description:
600mg BID ATC
Treatment:
Drug: AVX754
800mg BID ATC
Experimental group
Description:
800mg BID ATC
Treatment:
Drug: AVX754
150mg BID 3TC
Active Comparator group
Description:
150mg BID 3TC
Treatment:
Drug: 3TC

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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