Phase 4
Completed N=30
An Open Label Trial of Stribild for Antiretroviral (ARV)-naïve HIV-2 Infected Adults in Dakar, Senegal
Source: ClinicalTrials.gov NCT02180438 ↗Enrolled (actual)
30
Serious AEs
3.3%
Results posted
May 2018
Primary outcomePrimary: Death — 0 Participants
◆ Published Evidence
Established
36citations · ~5 / year
A Trial of a Single-tablet Regimen of Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir Disoproxil Fumarate for the Initial Treatment of Human Immunodeficiency Virus Type 2 Infection in a Resource-limited Setting: 48-Week Results From Senegal, West Africa.
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
Linked Publications
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A Trial of a Single-tablet Regimen of Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir Disoproxil Fumarate for the Initial Treatment of Human Immunodeficiency Virus Type 2 Infection in a Resource-limited Setting: 48-Week Results From Senegal, West Africa.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Death |
— | — |
| PRIMARY New WHO Stage 3 or 4 Event |
— | — |
| PRIMARY Virologic Failure, FDA Snapshot (HIV-2 Plasma Viral Load >50 and >400 Copies/ml) |
1; 0 | — |
| SECONDARY Grade 3 or 4 Adverse Events |
7; 1 | — |
| SECONDARY CD4 T-cell Count at 48 Weeks < Baseline |
— | — |
| SECONDARY < 50 CD4 T-cell Increase at 48 Weeks From Baseline |
2 | — |
| SECONDARY Switching Off Stribild Prior to 48 Weeks |
— | — |
| SECONDARY Development of Drug Resistance Mutations to Elvitegravir or Emtricitabine or Tenofovir DF |
1 | — |
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT02180438) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.