Clinical trial NCT00820118: Early and Intermittent Antiretroviral Therapy in Naive HIV Infected Adults
Official title: ARNS 141 TIPI : A Pilot Trial to Assess the Ability of an Intermittent Antiretroviral Therapy in Maintaining an Immunological Stability in Antiretroviral naïve HIV Infected Adults, With CD4 Count Above 500/mm3
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Keywords: ANTIRETROVIRAL THERAPY
STRUCTURED TREATMENT INTERRUPTIONS
treatment naive
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
First posted: 2009-01-09
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: M21 and M24
Secondary outcomes:
measure: 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
timeFrame: M12 and M24
measure: number, type and time to AIDS and non AIDS-related serious clinical events
timeFrame: from week 0 to M24
measure: number, type and time to clinical and biological events (whatever the grade of severity)
timeFrame: from week 0 to M24
measure: existence and nature of HIV genotypic mutations associated with antiretroviral resistance
timeFrame: M9 and M24 and at any time visit in case of failure
measure: proportion of patients having followed the strategy of the trial
timeFrame: from week 0 to M24
measure: evolution of HIV RNA and HIV DNA throughout the study
timeFrame: from week 0 to M24 for RNA and each 6 months for DNA
measure: Quality of life and observance (questionnaires)
timeFrame: QL each 6 months, observance at M1, M6, M13 and M18
Other outcomes:
Locations:
city: Dijon
country: France
facility: Services maladies infectieuses et tropicales CHU
Study officials:
affiliation: Hôpital de Dijon, France
name: Lionel PIROTH, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Piroth L, Moinot L, Yeni P, Avettand-Fenoel V, Reynes J, Girard PM, Marchou B, Georget A, Rouzioux C, Autran B, Duvillard L, Chene G, Fagard C; ANRS 141 TIPI Trial Study Group. Immunity, inflammation and reservoir in patients at an early stage of HIV infection on intermittent ART (ANRS 141 TIPI Trial). J Antimicrob Chemother. 2016 Feb;71(2):490-6. doi: 10.1093/jac/dkv369. Epub 2015 Nov 14.