HIV Infection
Conditions
Keywords
HIV, apricitabine, drug resistance, reverse transcriptase, lamivudine
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.
Interventions
DRUGapricitabine
800mg apricitabine twice daily orally for 96 weeks
Sponsors
Avexa
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Australia
Outcome results
None listed