SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT00367952

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

An Open Label Long Term Safety Extension Study of Apricitabine in Treatment-experienced HIV-1 Infected Subjects

The study will examine how safe and effective apricitabine is when given long term (as ongoing treatment) to HIV patients who have already completed the AVX-201 trial

NCT00367952 HIV Infection
MeSH: HIV Infections

1 Interventions

Name: apricitabine

Description: 800mg apricitabine twice daily orally for 96 weeks

Type: Drug

ATC 800mg BID


Primary Outcomes

Measure: Time to virological failure (DHSS definition)

Time: week 144

Measure: incidence of AEs and laboratory abnormalities

Time: Week 144

Measure: time to withdrawal due to AEs

Time: Week 144

Secondary Outcomes

Measure: Change from baseline HIV RNA

Time: weeks 72, 96, 120, and 144

Measure: Proportion of subjects with plasma HIV RNA <400 and <50 copies/ml

Time: at weeks 72, 96, 120, and 144

Measure: Change from baseline and change in ratio of CD4+ and CD8+ counts

Time: at weeks 72, 96, 120, and 144

Purpose: Treatment

Allocation: Non-Randomized

Single Group Assignment


There is one SNP

SNPs


1 M184V

Inclusion Criteria: - Completed AVX-201 protocol, Plasma HIV RNA <5000 copies/ml, CD4 cells >50 Exclusion Criteria: - Pregnant or breastfeeding females, withdrawal from AVX-201 Inclusion Criteria: - Completed AVX-201 protocol, Plasma HIV RNA <5000 copies/ml, CD4 cells >50 Exclusion Criteria: - Pregnant or breastfeeding females, withdrawal from AVX-201 HIV Infection HIV Infections An ongoing study (AVX-201) is examining the safety and efficacy of apricitabine compared to 3TC in HIV patients who are failing therapy containing 3TC and have the presence of the M184V mutation in reverse transcriptase. --- M184V ---



HPO Nodes