HIV Infections Clinical Trial
Official title:
A Randomised, Open-label Trial to Assess the Safety and Efficacy of Switching to Tenofovir-emtricitabine or Abacavir-lamivudine: The STEAL Study.
Combination antiretroviral therapy for the treatment of HIV has a high pill burden. Two dual-tablets, abacavir-lamivudine and tenofovir-emtricitabine, are now licensed in the United States and will be available in Australia in December 2005. Data available suggest that the potency of these tablets are similar in controlling replication of the HIV virus, but not have not been directly compared in regard to clinically significant toxicities. We therefore aim to compare the overall safety and efficacy of the two dual-tablets over a 2 year period in HIV infected adults. We hypothesise that the two dual-NRTI treatments will be similar in efficacy and safety.
The aim of this study is to compare the overall safety and efficacy of two dual-NRTI, once
daily, tablets over a 2 year period in HIV infected adults.
The study is a randomised, multi-centre, 2 year study of two dual NRTI, once daily tablets
in subjects with HIV, currently taking two individual NRTIs as part of their therapy. 350
subjects will be randomised in a 1:1 ratio to either:
1. tenofovir (TDF) 300mg + emtricitabine (FTC) 200mg OR
2. abacavir (ABC) 600mg + lamivudine (3TC) 300mg. Subjects will cease their current
individual NRTI treatment, commence their randomised dual NRTI tablet, and continue on
their current NNRTI or PI therapy.
Subjects will be stratified by the type of NRTI they are currently taking (ABC, TDF or
other); whether they are currently taking a protease inhibitor (yes or no); and by the site
where they are randomised. A study plan is enclosed
Subjects will be closely monitored (at 1 month and then every 3 months until week 96) for
safety by evaluating the incidence and severity of adverse effects/abnormal laboratory
parameters. Study investigations enclosed. It is optional whether subjects also provide
plasma, serum and cells (PBMCs) for storage. These samples will be available for analysis
for sub-studies agreed to through the IVRN expression of interest network.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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