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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00126880
• Other study ID #: AVX-201
• Status: Completed
• Phase: Phase 2
• First received: August 3, 2005
• Last updated: June 22, 2011
• Start date: July 2005
• Est. completion date: January 2008

Study information

• Verified date: June 2011
• Source: Avexa
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationAustralia: Department of Health and Ageing Therapeutic Goods AdministrationArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• AVX754
apricitabine, 600mg BID or 800mg BID
• 3TC
3TC, 150mg BID

Locations

Country	Name	City	State
Australia	Avexa (co-ordinating sites in Australia and Argentina)	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Avexa

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in HIV RNA levels at day 21		day 21	No
Primary	Time-weighted average change from baseline in HIV RNA levels through 21 days		21 days	No
Secondary	Change from baseline in HIV RNA levels at days 7, 14, 21		days 7, 14, 21	No
Secondary	Proportion of subjects with HIV RNA levels <400 or <50 at days 7, 14, 21, and weeks 24 and 48		days 7, 14, 21, and weeks 24 and 48	No
Secondary	Change from baseline and change in ratio of CD4+ and CD8+ cells at day 21 and weeks 24 and 48		day 21 and weeks 24 and 48	No