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Report for Clinical Trial NCT00126880

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

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.

NCT00126880 HIV Infections
MeSH:HIV Infections

2 Interventions

Name: AVX754

Description: apricitabine, 600mg BID or 800mg BID
Type: Drug
Group Labels: 2

600mg BID ATC 800mg BID ATC

Name: 3TC

Description: 3TC, 150mg BID
Type: Drug
Group Labels: 1

150mg BID 3TC


Primary Outcomes

Measure: Change from baseline in HIV RNA levels at day 21

Time: day 21

Measure: Time-weighted average change from baseline in HIV RNA levels through 21 days

Time: 21 days

Secondary Outcomes

Measure: Change from baseline in HIV RNA levels at days 7, 14, 21

Time: days 7, 14, 21

Measure: Proportion of subjects with HIV RNA levels <400 or <50 at days 7, 14, 21, and weeks 24 and 48

Time: days 7, 14, 21, and weeks 24 and 48

Measure: Change from baseline and change in ratio of CD4+ and CD8+ cells at day 21 and weeks 24 and 48

Time: day 21 and weeks 24 and 48

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 M184V

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. --- M184V ---

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 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 HIV Infections HIV Infections Lamivudine or emtricitabine are commonly used in combination with other drugs for first-line treatment of HIV infection. --- M184V ---

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 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 HIV Infections HIV Infections Lamivudine or emtricitabine are commonly used in combination with other drugs for first-line treatment of HIV infection. --- M184V --- --- M184V ---

Resistance is associated with characteristic mutations, which for lamivudine is the M184V mutation. --- M184V ---



HPO Nodes