Trial Evaluating a First Line Combination Therapy With Raltegravir, Emtricitabine and Tenofovir in HIV-2 Infected Patients
Condition: HIV-2 Infection
Intervention: emtricitabine / tenofovir disoproxil fumarate / raltegravir .
Intervention description: 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.
Intervention MeSH terms: Tenofovir; Emtricitabine; Raltegravir Potassium; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV-2

Summary:

      The HIV-2 is less common ie 1-2 million people in West Africa. HIV-2 does have the same
      sensitivity 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.
    

Eligibility 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.