HIV Infections
Conditions
Keywords
ANTIRETROVIRAL THERAPY, STRUCTURED TREATMENT INTERRUPTIONS, treatment naive
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.
Interventions
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
Sponsors
ANRS, Emerging Infectious Diseases
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| 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 |
| proportion of patients having followed the strategy of the trial | from week 0 to M24 |
Countries
France
Outcome results
None listed