Clinical Trials

MainTitle

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

This study has been completed
Sponsor
University of Washington

Collaborator
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: May 25, 2017
Last Verified: May 2017
History of Changes
Purpose

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: 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

Further study details as provided by Geoffrey S. Gottlieb, University of Washington:

Primary Outcome Measures

  • Death [ Time Frame: 48 weeks ]
  • New WHO stage 3 or 4 event [ Time Frame: 48 weeks ]
  • Virologic failure, FDA Snapshot (HIV-2 plasma viral load >50 and >400 copies/ml) [ Time Frame: 48 weeks ]
Secondary Outcome Measures:
  • Grade 3 or 4 adverse events [ Time Frame: 48 weeks ]
  • CD4 T-cell count at 48 weeks < baseline [ Time Frame: 48 weeks ]
  • < 50 CD4 T-cell increase at 48 weeks from baseline [ Time Frame: 48 weeks ]
  • Switching off Stribild prior to 48 weeks [ Time Frame: 48 Weeks ]
  • Development of Drug Resistance Mutations to TDF, FTC or EVG [ Time Frame: 48 weeks ]
Other Outcome Measures:
  • Interim 24 weeks analysis of death [ Time Frame: 24 weeks ]
  • Interim analysis at 24 weeks of New WHO stage 3 or 4 event [ Time Frame: 24 weeks ]
  • 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)
  • Interim analysis at 24 weeks of Grade 3 and 4 adverse events [ Time Frame: 24 weeks ]

Enrollment: 30
Study Start Date: September 2014
Study Completion Date: January 2017
Primary Completion Date: January 2017 (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

Eligibility

Ages Eligible for Study: 18 Years and older  
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

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

Locations

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

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

More Information


Responsible Party: Geoffrey S. Gottlieb, Associate Professor, Medicine, University of Washington  
ClinicalTrials.gov Identifier: NCT02180438   History of Changes  
Other Study ID Numbers: STUDY00000757  
Study First Received: May 29, 2014  
Last Updated: May 25, 2017  

Keywords provided by Geoffrey S. Gottlieb, University of Washington:

HIV-2

Additional relevant MeSH terms:
Tenofovir
Emtricitabine
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Cobicistat
Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

ClinicalTrials.gov processed this data on December 11, 2017
This information is provided by ClinicalTrials.gov.