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NCT Number: NCT02180438

An Open Label Trial of Stribild for Antiretroviral (ARV)-naïve HIV-2 Infected Adults in Dakar, Senegal

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

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Key information

Conditions

HIV-2 Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Clinique des Maladies Infectieuses Ibrahima DIOP Mar/CRCF, Centre Hospitalier Universitaire de Fann

Dakar, Senegal

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF) 1 tablet daily X 48 weeks

Drug

Primary outcomes

  1. Death

    Time frame: 48 weeks

    Number of Participants Experiencing Death within the study period

  2. New WHO Stage 3 or 4 Event

    Time frame: 48 weeks

    New AIDS defining event per WHO criteria

  3. Virologic Failure, FDA Snapshot (HIV-2 Plasma Viral Load >50 and >400 Copies/ml)

    Time frame: 48 weeks

Secondary outcomes

  1. Grade 3 or 4 Adverse Events

    Time frame: 48 weeks

    Adverse event per NIH/DAIDS criteria

  2. CD4 T-cell Count at 48 Weeks < Baseline

    Time frame: 48 weeks

  3. < 50 CD4 T-cell Increase at 48 Weeks From Baseline

    Time frame: 48 weeks

  4. Switching Off Stribild Prior to 48 Weeks

    Time frame: 48 Weeks

  5. Development of Drug Resistance Mutations to Elvitegravir or Emtricitabine or Tenofovir DF

    Time frame: 48 weeks

Other outcomes

  1. Interim 24 Weeks Analysis of Death

    Time frame: 24 weeks

  2. Interim Analysis at 24 Weeks of New WHO Stage 3 or 4 Event

    Time frame: 24 weeks

  3. Interim Analysis at 24 Weeks of HIV-2 Virologic Failure

    Time frame: 24 weeks

    Virologic failure, FDA Snapshot (HIV-2 plasma viral load >50 and >400 copies/ml)

  4. Interim Analysis at 24 Weeks of Grade 3 and 4 Adverse Events

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • Clinique des Maladies Infectieuses Ibrahima DIOP Mar/CRCF, Centre Hospitalier Universitaire de Fann
  • Gilead Sciences

Registry information

Official study title

An Open Label Trial of STRIBILD™ (Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate) for ARV-naïve HIV-2 Infected Adults in Dakar, Senegal

Acronym: Stribild HIV-2

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jul 2, 2014
Registry last updated
Jul 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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