Early and Intermittent Antiretroviral Therapy in Naive HIV Infected Adults (TIPI)

This study has been completed.
Sponsor:
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

January 8, 2009
May 22, 2012
May 2009
May 2012   (final data collection date for primary outcome 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. [ Time Frame: M21 and M24 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00820118 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Early and Intermittent Antiretroviral Therapy in Naive HIV Infected Adults
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

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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
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 :

  • 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
Other Names:
  • Reyataz
  • Truvada
  • Kivexa
  • Treatment interruption
  • STI
Experimental: Intermittent treatment
6 months on antiretroviral treatment and 6 months off treatment
Intervention: Drug: Structured treatment interruption
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
May 2012
May 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00820118
ANRS 141 TIPI
Yes
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Not Provided
Principal Investigator: Lionel PIROTH, MD, PHD Hôpital de Dijon, France
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP