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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2014 by University of Washington
Sponsor:
Collaborators:
Clinique des Maladies Infectieuses Ibrahima DIOP Mar/CRCF, Centre Hospitalier Universitaire de Fann
Gilead Sciences
Information provided by (Responsible Party):
Geoffrey S. Gottlieb, University of Washington
ClinicalTrials.gov Identifier:
NCT02180438
First received: May 29, 2014
Last updated: July 1, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention Phase
HIV-2 Infection
Drug: Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF) 1 tablet daily X 48 weeks
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Trial of STRIBILD™ (Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate) for ARV-naïve HIV-2 Infected Adults in Dakar, Senegal

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Death [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • New WHO stage 3 or 4 event [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Virologic failure, FDA Snapshot (HIV-2 plasma viral load >50 and >400 copies/ml) [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Grade 3 or 4 adverse events [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • CD4 T-cell count at 48 weeks < baseline [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • < 50 CD4 T-cell increase at 48 weeks from baseline [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Switching off Stribild prior to 48 weeks [ Time Frame: 48 Weeks ] [ Designated as safety issue: Yes ]
  • Development of Drug Resistance Mutations to TDF, FTC or EVG [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Interim 24 weeks analysis of death [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Interim analysis at 24 weeks of New WHO stage 3 or 4 event [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Interim analysis at 24 weeks of HIV-2 Virologic Failure [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Virologic failure, FDA Snapshot (HIV-2 plasma viral load >50 and >400 copies/ml)

  • Interim analysis at 24 weeks of Grade 3 and 4 adverse events [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Open label prospective single arm study of Stribild Drug: Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF) 1 tablet daily X 48 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent
  • Age > 18 years old
  • HIV-2 Infection (confirmed by DetermineTM & Immunocomb II)
  • ARV-naïve
  • CD4 count < 500 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02180438

Contacts
Contact: Geoffrey S Gottlieb, MD PhD 206 616-2631 gottlieb@uw.edu
Contact: Moussa Seydi, MD seydi.moussa@gmail.com

Locations
Senegal
Clinique des Maladies Infectieuses Ibrahima DIOP Mar/CRCF, Centre Hospitalier Universitaire de Fann Not yet recruiting
Dakar, Senegal
Contact: Moussa Seydi, MD    221 33 869 18 88    seydi.moussa@gmail.com   
Principal Investigator: Moussa Seydi, MD         
Sponsors and Collaborators
University of Washington
Clinique des Maladies Infectieuses Ibrahima DIOP Mar/CRCF, Centre Hospitalier Universitaire de Fann
Gilead Sciences
Investigators
Principal Investigator: Geoffrey S Gottlieb, MD PhD University of Washington
Principal Investigator: Moussa Seydi, MD Clinique des Maladies Infectieuses Ibrahima DIOP Mar/CRCF, Centre Hospitalier Universitaire de Fann
  More Information

No publications provided

Responsible Party: Geoffrey S. Gottlieb, Associate Professor, Medicine, University of Washington
ClinicalTrials.gov Identifier: NCT02180438     History of Changes
Other Study ID Numbers: 46565-A
Study First Received: May 29, 2014
Last Updated: July 1, 2014
Health Authority: United States: Institutional Review Board
Senegal: Ministere de la sante

Keywords provided by University of Washington:
HIV-2

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Tenofovir
Tenofovir disoproxil
Emtricitabine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on September 11, 2014