Early and Intermittent Antiretroviral Therapy in Naive HIV Infected Adults
Status:
Completed
Trial end date:
2012-05-01
Target enrollment:
Participant gender:
Summary
The primary objective of the trial is to assess the ability of an early and intermittent
antiretroviral therapy in maintaining an immunological stability in antiretroviral naive HIV
infected adults, to offer a potential alternative strategy to differed and continuous
antiretroviral treatment.This is a 2-year phase II, open-label, multicentric "proof of
concept" trial. The patients included are treated following a pulse-therapy scheme, i.e.
6-month periods with once daily boosted-PI based therapy in alternance with 6-month periods
without antiretroviral therapy. The preferentially recommended treatment of the study is
atazanavir boosted with ritonavir, associated with a fixed combination of abacavir and
lamivudine or emtricitabine + tenofovir.The patients are closely followed to assess the
efficacy and the tolerance of the strategy, with clinical, biochemical, immunological,
virological and pharmacokinetic evaluations.
Phase:
Phase 2
Details
Lead Sponsor:
ANRS, Emerging Infectious Diseases French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Treatments:
Atazanavir Sulfate Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination