Early and Intermittent Antiretroviral Therapy in Naive HIV Infected Adults
- Conditions
- HIV Infections
- Interventions
- Drug: Structured treatment interruption
- Registration Number
- NCT00820118
- Lead Sponsor
- ANRS, Emerging Infectious Diseases
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
- adult confirmed HIV-1 infection
- no previous treatment with antiretroviral drugs or interleukin-2
- CD4 count ≥ 500/mm3
- no active opportunistic infection
- written informed consent
- non barrier contraception in women of child bearing potential, pregnant or breastfeeding woman, pregnancy project within the next 2 years
- HIV-2 infection (with or without HIV-1), recent HIV primary infection, resistance to trial drugs at study entry, Ag HBs+, HCV requiring specific therapy
- previous history of cerebrovascular accident or coronary heart disease, splenectomy
- previous CD4 count < 400/mm3
- CD4 percentage < 15%
- hemoglobin < 8 g/dl, neutrophils < 750/mm3, platelets < 100.000/mm3, creatinine clearance < 50 ml/mn, AST or ALT or total bilirubin > 3 ULN
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intermittent treatment Structured treatment interruption 6 months on antiretroviral treatment and 6 months off treatment
- Primary Outcome Measures
Name Time Method 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. M21 and M24
- Secondary Outcome Measures
Name Time Method proportion of patients having followed the strategy of the trial from week 0 to M24 existence and nature of HIV genotypic mutations associated with antiretroviral resistance M9 and M24 and at any time visit in case of failure 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 M12 and M24 number, type and time to AIDS and non AIDS-related serious clinical events from week 0 to M24 number, type and time to clinical and biological events (whatever the grade of severity) from week 0 to M24 evolution of HIV RNA and HIV DNA throughout the study from week 0 to M24 for RNA and each 6 months for DNA Quality of life and observance (questionnaires) QL each 6 months, observance at M1, M6, M13 and M18
Trial Locations
- Locations (1)
Services maladies infectieuses et tropicales CHU
🇫🇷Dijon, France