Trial record 19 of 31 for:    " December 31, 2008":" January 30, 2009"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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
  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:


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 :

  • 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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014