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	Phase II

Further Study Details: 

Primary Outcomes: Change from baseline in HIV RNA levels at day 21; Time-weighted average change from baseline in HIV RNA levels through 21 days
Secondary Outcomes: 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
Expected Total Enrollment:  60

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.

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00126880

Susan W Cox, Ph D      +61 3 9208 4300  Ext. 4066    scox@avexa.com.au

Australia, Victoria
      Avexa (co-ordinating sites in Australia and Argentina), Melbourne,  Victoria,  3121,  Australia; Recruiting

Study ID Numbers:  AVX-201
Last Updated:  August 19, 2005
Record first received:  August 3, 2005
ClinicalTrials.gov Identifier:  NCT00126880
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
ClinicalTrials.gov processed this record on 2005-08-23