A Long Term, Safety Study of Apricitabine in HIV-infected Subjects
- Registration Number
- NCT00367952
- Lead Sponsor
- Avexa
- Brief Summary
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
- Detailed Description
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. This extension study (AVX-201E) is available to patients who complete the AVX-201 protocol.
Patients will continue to receive apricitabine open label for a further 96 weeks (making a total of 144 weeks from starting AVX-201) in addition to an optimised background. Safety markers and efficacy markers will be followed.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
- Completed AVX-201 protocol, Plasma HIV RNA <5000 copies/ml, CD4 cells >50
- Pregnant or breastfeeding females, withdrawal from AVX-201
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ATC 800mg BID apricitabine 800mg ATC BID
- Primary Outcome Measures
Name Time Method Time to virological failure (DHSS definition) week 144 incidence of AEs and laboratory abnormalities Week 144 time to withdrawal due to AEs Week 144
- Secondary Outcome Measures
Name Time Method Change from baseline HIV RNA weeks 72, 96, 120, and 144 Proportion of subjects with plasma HIV RNA <400 and <50 copies/ml at weeks 72, 96, 120, and 144 Change from baseline and change in ratio of CD4+ and CD8+ counts at weeks 72, 96, 120, and 144
Trial Locations
- Locations (1)
Avexa (co-ordinating sites in Australia and Argentina)
🇦🇺Melbourne, Victoria, Australia