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

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ClinicalTrials.gov Identifier: NCT00820118
Recruitment Status : Completed
First Posted : January 9, 2009
Last Update Posted : May 23, 2012
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)

Study Description
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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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Structured treatment interruption Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : May 2009
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  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. [ Time Frame: M21 and M24 ]

Secondary Outcome Measures :
  1. 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 ]
  2. number, type and time to AIDS and non AIDS-related serious clinical events [ Time Frame: from week 0 to M24 ]
  3. number, type and time to clinical and biological events (whatever the grade of severity) [ Time Frame: from week 0 to M24 ]
  4. 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 ]
  5. proportion of patients having followed the strategy of the trial [ Time Frame: from week 0 to M24 ]
  6. 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 ]
  7. Quality of life and observance (questionnaires) [ Time Frame: QL each 6 months, observance at M1, M6, M13 and M18 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00820118


Locations
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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
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Principal Investigator: Lionel PIROTH, MD, PHD Hôpital de Dijon, France
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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    
Other Study ID Numbers: ANRS 141 TIPI
First Posted: January 9, 2009    Key Record Dates
Last Update Posted: May 23, 2012
Last Verified: May 2012
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:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Atazanavir Sulfate
 Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
HIV Protease Inhibitors
Protease Inhibitors