SNPMiner Trials by Shray Alag


SNPMiner SNPMiner Trials (Home Page)


Report for Clinical Trial NCT00367952

Developed by Shray Alag, 2020.
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