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

Phase 4

Completed

Conditions: HIV-2 Infection

Interventions: Drug: Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF) 1 tablet daily X 48 weeks

Registration Number: NCT02180438

Lead Sponsor: University of Washington

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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 30

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open label prospective single arm study of Stribild	Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF) 1 tablet daily X 48 weeks	-

Primary Outcome Measures

Name	Time	Method
Virologic Failure, FDA Snapshot (HIV-2 Plasma Viral Load >50 and >400 Copies/ml)	48 weeks
Death	48 weeks	Number of Participants Experiencing Death within the study period
New WHO Stage 3 or 4 Event	48 weeks	New AIDS defining event per WHO criteria

Secondary Outcome Measures

Name	Time	Method
Development of Drug Resistance Mutations to Elvitegravir or Emtricitabine or Tenofovir DF	48 weeks
Grade 3 or 4 Adverse Events	48 weeks	Adverse event per NIH/DAIDS criteria
< 50 CD4 T-cell Increase at 48 Weeks From Baseline	48 weeks
CD4 T-cell Count at 48 Weeks < Baseline	48 weeks
Switching Off Stribild Prior to 48 Weeks	48 Weeks