Early and Intermittent Antiretroviral Therapy in Naive HIV Infected Adults
TIPI
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
1 other identifier
interventional
45
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 hiv-infections
Started May 2009
Typical duration for phase_2 hiv-infections
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 8, 2009
CompletedFirst Posted
Study publicly available on registry
January 9, 2009
CompletedStudy Start
First participant enrolled
May 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedMay 23, 2012
May 1, 2012
3 years
January 8, 2009
May 22, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
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
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 having followed the strategy of the trial
from week 0 to M24
- +2 more secondary outcomes
Study Arms (1)
Intermittent treatment
EXPERIMENTAL6 months on antiretroviral treatment and 6 months off treatment
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Services maladies infectieuses et tropicales CHU
Dijon, France
Related Publications (1)
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.
PMID: 26568566DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lionel PIROTH, MD, PHD
Hôpital de Dijon, France
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 8, 2009
First Posted
January 9, 2009
Study Start
May 1, 2009
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
May 23, 2012
Record last verified: 2012-05