An Open Label Trial of Stribild for Antiretroviral (ARV)-naïve HIV-2 Infected Adults in Dakar, Senegal
Condition: HIV-2 Infection
Intervention: Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF) 1 tablet daily X 48 weeks
Intervention MeSH terms: Tenofovir; Emtricitabine; Cobicistat; Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Elvitegravir
Phase: Phase 4
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:

      There is a critical need for safe and effective antiretroviral treatment (ART) regimens for
      HIV-2 infection. This is especially true in West Africa, where the vast majority of the 1-2
      million individuals infected with HIV-2 live and were access to effective ART for HIV-2 is
      limited. HIV-2 is intrinsically resistant to non-nucleoside reverse transcriptase inhibitors
      (NNRTI) and the fusion inhibitor enfuvirtide (T-20) and mutations conferring broad resistance
      to nucleoside/nucleotide reverse transcriptase inhibitors (NRTI) are frequently observed in
      HIV-2 from patients receiving ART. Although antiretroviral protease inhibitors (PI) can be
      used effectively to treat HIV- 2, HIV-1 and HIV-2 also exhibit important differences in their
      susceptibilities with studies indicating that saquinavir (SQV), lopinavir (LPV), and
      darunavir (DRV) are the only potent PI's against HIV-2 replication and cross-resistance is
      frequent. Although an increasing body of evidence supports the potential utility of integrase
      inhibitors (INI) against HIV-2, there have been no clinical trials to assess their
      effectiveness and they are not routinely available in resource-limited settings. These
      limitations present major challenges to HIV-2 treatment, particularly in the areas in which
      it is most prevalent. This study is the 1st use of STRIBILD (elvitegravir (EVG), cobicistat
      (COBI), emtricitabine (FTC), tenofovir disoproxil fumarate (TDF)), an INI-based single tablet
      regimen, in HIV-2 infected adults in West Africa. The investigators hypothesize STRIBILD will
      be safe and effective as ART for HIV-2 infection. The Specific Aims of this study are: AIM 1:
      A pilot, open label, 48 week trial of STRIBILD (elvitegravir, cobicistat, emtricitabine,
      tenofovir disoproxil fumarate) in 30 ARV-naïve HIV-2 Infected Adults in Dakar, Senegal. AIM
      2: Determination of genotypic and phenotypic HIV-2 antiretroviral resistance in individuals
      with virologic failure (HIV-2 plasma RNA >250 copies/ml) participating in the 48 week trial
      of STRIBILD
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent

          -  Age > 18 years old

          -  HIV-2 Infection (confirmed by DetermineTM & Immunocomb II)

          -  ARV-naïve

          -  CD4 count < 750 cells/mm3 and/or WHO Stage 3 or 4 disease

          -  Anticipate residing in Dakar area for duration of study

        Exclusion Criteria:

          -  Pregnancy or Breast feeding

          -  HIV-1 or HIV-1/HIV-2 dual infection

          -  Known allergy or contraindication to Elvitegravir, Cobicistat, Emtricitabine, or
             Tenofovir DF

          -  Active Tuberculosis (STRIBILD contraindicated with rifampin)