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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02180438
Recruitment Status : Completed
First Posted : July 2, 2014
Results First Posted : May 8, 2018
Last Update Posted : July 26, 2018
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

Study Description
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Brief 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

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : September 2014
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Arm Intervention/treatment
Experimental: Open label prospective single arm study of Stribild Drug: Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF) 1 tablet daily X 48 weeks


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 < 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)
Contacts and Locations
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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): NCT02180438


Locations
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Senegal
Clinique des Maladies Infectieuses Ibrahima DIOP Mar/CRCF, Centre Hospitalier Universitaire de Fann
Dakar, Senegal
Sponsors and Collaborators
University of Washington
Clinique des Maladies Infectieuses Ibrahima DIOP Mar/CRCF, Centre Hospitalier Universitaire de Fann
Gilead Sciences
Investigators
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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
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Geoffrey S. Gottlieb, Associate Professor, Medicine, University of Washington
ClinicalTrials.gov Identifier: NCT02180438    
Other Study ID Numbers: STUDY00000757
First Posted: July 2, 2014    Key Record Dates
Results First Posted: May 8, 2018
Last Update Posted: July 26, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Geoffrey S. Gottlieb, University of Washington:
HIV-2
Additional relevant MeSH terms:
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Tenofovir
Emtricitabine
Cobicistat
Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Elvitegravir
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
 Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Integrase Inhibitors