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Trial Evaluating a First Line Combination Therapy With Raltegravir, Emtricitabine and Tenofovir in HIV-2 Infected Patients (VIH-2)

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ClinicalTrials.gov Identifier: NCT01605890
Recruitment Status : Completed
First Posted : May 25, 2012
Last Update Posted : July 12, 2016
Sponsor:
Collaborators:
Gilead Sciences
Merck Sharp & Dohme Corp.
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 HIV-2 is less common ie 1-2 million people in West Africa. HIV-2 does have the same sensibility to antiretroviral treatment (ART) compared to HIV-1. The ART strategies that are appropriate for the HIV-1 infection are not as effective for HIV-2. Classical triple therapy including PI is less effective for HIV-2. Also, the choice of ARTs in a second line treatment is limited. The first line optimal treatment has to be defined by a prospective and randomized evaluation of other strategies. The primary endpoint will be adapted to the specificity of the HIV-2 infection. The 1st step is to define, with a phase II clinical trial, whether a strategy including 2 NRTIs and raltegravir, as an alternative strategy to the classical triple therapy, shows an immunovirological response, at least, as good as the one obtained with the triple therapy. The hypothesis is that the low ART response observed in HIV-2 infection is due to a low virological strength of the ARTs used and that the combination of 2 NRTIs and raltegravir should show a therapeutic success of at least 50% at week 48.

Condition or disease Intervention/treatment Phase
HIV-2 Infection Drug: emtricitabine / tenofovir disoproxil fumarate / raltegravir . Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ANRS 159 VIH-2 : Trial Evaluating a First Line Combination Therapy With Raltegravir, Emtricitabine and Tenofovir in HIV-2 Infected Patients
Study Start Date : July 2012
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: raltegravir / emtricitabine / tenofovir disoproxil fumarate Drug: emtricitabine / tenofovir disoproxil fumarate / raltegravir .

emtricitabine : 200 mg/day and tenofovir disoproxil fumarate : 300 mg/day, included in one pill of Truvada® QD.

raltegravir : 400 mg x 2/day, 400 mg in one pill of Isentress® BID.


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of participants in therapeutic success [ Time Frame: at Week 48 ]

    The participants will be considered in therapeutic success at Week 48 if they did not present any of the following events:

    • Plasma HIV-2 RNA load over or equal to 100 copies/mL, starting from Week 24 and confirmed within the next 4 weeks,
    • CD4 lymphocytes gain below 100/mm3 at Week 48 compared to the CD4 lymphocytes counts average between Week-4 and Week 0,
    • Raltegravir permanent discontinuation,
    • Death from any cause,
    • New B or C events confirmed by an endpoint review committee


Secondary Outcome Measures :
  1. Gain in CD4 lymphocytes count [ Time Frame: between Week 0 and Week 12 ]
  2. Tolerance of the treatment [ Time Frame: from Week 0 to Week 48 ]
    • number, nature, severity and time to adverse event.
    • evolution of the metabolic disorders, clinical and biological measurement

  3. Evolution of the number and percentage of CD4 lymphocytes [ Time Frame: between Week 0 and Week 48 ]
  4. Evolution of plasma HIV-2 RNA load [ Time Frame: between Week 0 and Week 48 ]
  5. The rate of clinical progression will be defined as the switch [ Time Frame: from Week 0 to Week 48 ]
    • from category A to B, C or death.
    • from category B to C or death.

  6. Adherence evaluated with ANRS self-administered questionnaire of adherence and plasma measurements of residual concentrations of antiretroviral drugs in viral failure cases [ Time Frame: from Week 0 to Week 48 ]
  7. Description of the resistance mutations'profile in virological failure cases [ Time Frame: from Week 0 to Week 48 ]

    Description of the resistance mutations'profile in virological failure cases (plasma HIV-2 RNA load over or equal to 100 copies/mL after plasma HIV-2 RNA load below 100copies/mL, confirmed with a retest within the 4 following weeks) with:

    • the number and type of mutations in the RT and integrase genes compared to Week 0.
    • the evolution of the phenotypic sensitivity of raltegravir and NRTIs compared to Week 0

  8. Frequency of treatment switch or discontinuation [ Time Frame: from Week 0 to Week 48 ]
    • overall (regardless of the molecule).
    • for each study drug (raltegravir and emtricitabine/tenofovir disoproxil fumarate combination).

  9. Evolution of plasma HIV-2 DNA load in PBMC [ Time Frame: at Week 24 and Week 48 and compared to those performed at Week 0 ]
  10. Evolution of the quality of life [ Time Frame: from Week 0 to Week 48 ]
    through PROQOL questionnaire


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age ≥18 years
  • HIV-2 mono infection, confirmed by ELISA and Western Blot test or Immunoblot,
  • antiretroviral treatment-naive, whatever the duration and indication of prior treatments,
  • indication to treatment, with at least one of the following criteria : type B or C events, CD4 lymphocytes count below 500/mm3 at screening-visit or CD4 lymphocytes count decrease of at least 50 cell/µL/year over the last 3 years with the last CD4 lymphocytes count within -/+ 10 % of the nadir, plasma HIV-2 RNA load over or equal to 100 copies/mL at screening-visit,
  • Pneumocystis prophylaxis if CD4 lymphocytes count below 200/mm3, combined to a toxoplasmosis prophylaxis in case of a positive toxoplasmosis serology,
  • French residency for at least one year,
  • Written informed consent, signed by the participant and the investigator (at the latest on the screening-visit and prior any study related intervention)
  • Affiliate or beneficiary of a social security system (State Medical Assistance is not a social security scheme).

Exclusion Criteria:

  • Absence of effective contraception method(women),
  • Pregnancy, breastfeeding or wish for pregnancy during the trial,
  • Curative treatment of a progressive opportunistic infection not compatible with those evaluated in the present study,
  • Malignant or tumorous affection requiring chemotherapy or radiotherapy,
  • Decompensated cirrhosis,
  • Viral hepatitis C with a Metavir score over F2,
  • Hemoglobinemia below 7g/dL, polynuclear neutrophils below 500/mm3, platelets below 50 000/mm3, creatinine clearance below 50 mL/mn, transaminase, alkaline phosphatase or bilirubin over 2.5N,
  • Contraindication to one of the excipients of study treatments,
  • Insuline-dependent diabetes mellitus not well controlled (with glycated haemoglobin (HbA1C) over 7%),
  • Long-term corticosteroid treatment (more than 3 weeks of treatment),
  • Judicial protection, legal guardianship,
  • Participation in other therapeutic trial or comprising an exclusion period ongoing at the time of the screening-visit.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT01605890


Locations
France
Hôpital Bichat-Claude Bernard
Paris, France, 75018
Sponsors and Collaborators
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Gilead Sciences
Merck Sharp & Dohme Corp.
Investigators
Study Chair: Sophie Matheron, Pr Hopital Bichat-Claude Bernard
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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: NCT01605890     History of Changes
Other Study ID Numbers: 2011-005038-20
ANRS 159 VIH-2
First Posted: May 25, 2012    Key Record Dates
Last Update Posted: July 12, 2016
Last Verified: July 2016

Keywords provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):
HIV-2

Additional relevant MeSH terms:
Tenofovir
Raltegravir Potassium
Emtricitabine
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
 Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents
HIV Integrase Inhibitors
Integrase Inhibitors