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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
The preferentially recommended treatment of the study is atazanavir boosted with ritonavir, associated with a fixed combination of abacavir and lamivudine or emtricitabine + tenofovir Usual dosage recommended : * atazanavir : 300 mg/d * ritonavir : 100 mg/d * abacavir 600 mg and lamivudine 300 mg : once a day * tenofovir 245 mg and emtricitabine 200 mg : once a day
Services maladies infectieuses et tropicales CHU
Dijon, France
proportion of patients with mean CD4 count at M21 and M24 above or equal to the mean CD4 count at screening and inclusion, without experiencing a decrease below 400/mm3 throughout the study.
Time frame: M21 and M24
proportion of patients following the strategy of the trial and with AIDS related and non AIDS-related (cardiovascular, renal, hepatic, infectious, cancerous) serious clinical event
Time frame: M12 and M24
number, type and time to AIDS and non AIDS-related serious clinical events
Time frame: from week 0 to M24
number, type and time to clinical and biological events (whatever the grade of severity)
Time frame: from week 0 to M24
existence and nature of HIV genotypic mutations associated with antiretroviral resistance
Time frame: M9 and M24 and at any time visit in case of failure
proportion of patients having followed the strategy of the trial
Time frame: from week 0 to M24
evolution of HIV RNA and HIV DNA throughout the study
Time frame: from week 0 to M24 for RNA and each 6 months for DNA
Quality of life and observance (questionnaires)
Time frame: QL each 6 months, observance at M1, M6, M13 and M18
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