A Phase 2 interventional study of Structured treatment interruption in HIV Infections, sponsored by ANRS, Emerging Infectious Diseases. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-07.
Sponsored by ANRS, Emerging Infectious Diseases · Phase 2, Interventional, and Treatment
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.
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 45 is below the median of 83 across 3,251 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →ANRS, Emerging Infectious Diseases is the lead sponsor of 212 studies on the registry; 40 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
6 months on antiretroviral treatment and 6 months off treatment
Drug: Structured treatment interruption
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
Also known as: Reyataz, Truvada, Kivexa, Treatment interruption, STI
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
This study is completed, as verified in May 2012. You cannot join it, but the record below documents what was studied.
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ANRS, Emerging Infectious Diseases