Clinical Trials Logo

Clinical Trial 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


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT02180438
Study type Interventional
Source University of Washington
Contact
Status Completed
Phase Phase 4
Start date September 2014
Completion date January 2017

See also
  Status Clinical Trial Phase
Active, not recruiting NCT04888754 - A Prospective Cohort for ex Vivo Cure Studies With Chronic HIV Infected Patients in the Netherlands
Terminated NCT03394196 - RESIST-2: 2nd-line ART for HIV-2 Infection N/A
Completed NCT01605890 - Trial Evaluating a First Line Combination Therapy With Raltegravir, Emtricitabine and Tenofovir in HIV-2 Infected Patients Phase 2
Completed NCT02150993 - First-Line Treatment for HIV-2 Phase 2/Phase 3
Recruiting NCT05215704 - Ex Vivo Characterization and Targeting of the Latent HIV Infected Reservoir to Cure HIV
Recruiting NCT04658329 - Cohorte Nationale VIH-2
Completed NCT04971343 - Access HIV Ag/Ab Combo Assay - European Union (EU) Clinical Trial Protocol