Overview

This trial is active, not recruiting.

Condition hiv-2 infection
Treatment stribild (elvitegravir/cobicistat/emtricitabine/tenofovir df) 1 tablet daily x 48 weeks
Phase phase 4
Sponsor University of Washington
Collaborator Clinique des Maladies Infectieuses Ibrahima DIOP Mar/CRCF, Centre Hospitalier Universitaire de Fann
Start date September 2014
End date January 2017
Trial size 30 participants
Trial identifier NCT02180438, 46565-A

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
stribild (elvitegravir/cobicistat/emtricitabine/tenofovir df) 1 tablet daily x 48 weeks

Primary Outcomes

Measure
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 Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

Official title An Open Label Trial of STRIBILD™ (Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate) for ARV-naïve HIV-2 Infected Adults in Dakar, Senegal
Principal investigator Geoffrey S Gottlieb, MD PhD
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by University of Washington.