Trial record 14 of 26 for:
" December 17, 2008":" January 16, 2009"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]
Early and Intermittent Antiretroviral Therapy in Naive HIV Infected Adults (TIPI)
This study has been completed.
Sponsor:
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier:
NCT00820118
First received: January 8, 2009
Last updated: May 22, 2012
Last verified: May 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Structured treatment interruption |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
Further study details as provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
- number, type and time to AIDS and non AIDS-related serious clinical events [ Time Frame: from week 0 to M24 ] [ Designated as safety issue: Yes ]
- number, type and time to clinical and biological events (whatever the grade of severity) [ Time Frame: from week 0 to M24 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- proportion of patients having followed the strategy of the trial [ Time Frame: from week 0 to M24 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Quality of life and observance (questionnaires) [ Time Frame: QL each 6 months, observance at M1, M6, M13 and M18 ] [ Designated as safety issue: No ]
| Enrollment: | 45 |
| Study Start Date: | May 2009 |
| Study Completion Date: | May 2012 |
| Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Intermittent treatment
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 :
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00820118
Locations
| France | |
| Services maladies infectieuses et tropicales CHU | |
| Dijon, France | |
Sponsors and Collaborators
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Investigators
| Principal Investigator: | Lionel PIROTH, MD, PHD | Hôpital de Dijon, France |
More Information
Additional Information:
No publications provided
| Responsible Party: | French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS) |
| ClinicalTrials.gov Identifier: | NCT00820118 History of Changes |
| Other Study ID Numbers: | ANRS 141 TIPI |
| Study First Received: | January 8, 2009 |
| Last Updated: | May 22, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):
|
ANTIRETROVIRAL THERAPY STRUCTURED TREATMENT INTERRUPTIONS treatment naive |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
ClinicalTrials.gov processed this record on May 22, 2013