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

HIV-2 Infection Clinical Trial

— Stribild HIV-2  

Official title:

An Open Label Trial of STRIBILD™ (Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate) for ARV-naïve HIV-2 Infected Adults in Dakar, Senegal

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02180438
• Other study ID #: STUDY00000757
• Status: Completed
• Phase: Phase 4
• Start date: September 2014
• Est. completion date: January 2017

Study information

• Verified date: June 2018
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• HIV-2 Infection

Intervention

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

Locations

Country	Name	City	State
Senegal	Clinique des Maladies Infectieuses Ibrahima DIOP Mar/CRCF, Centre Hospitalier Universitaire de Fann	Dakar

Sponsors (3)

Lead Sponsor	Collaborator
University of Washington	Clinique des Maladies Infectieuses Ibrahima DIOP Mar/CRCF, Centre Hospitalier Universitaire de Fann, Gilead Sciences

Country where clinical trial is conducted

Senegal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Interim 24 Weeks Analysis of Death		24 weeks
Other	Interim Analysis at 24 Weeks of New WHO Stage 3 or 4 Event		24 weeks
Other	Interim Analysis at 24 Weeks of HIV-2 Virologic Failure	Virologic failure, FDA Snapshot (HIV-2 plasma viral load >50 and >400 copies/ml)	24 weeks
Other	Interim Analysis at 24 Weeks of Grade 3 and 4 Adverse Events		24 weeks
Primary	Death	Number of Participants Experiencing Death within the study period	48 weeks
Primary	New WHO Stage 3 or 4 Event	New AIDS defining event per WHO criteria	48 weeks
Primary	Virologic Failure, FDA Snapshot (HIV-2 Plasma Viral Load >50 and >400 Copies/ml)		48 weeks
Secondary	Grade 3 or 4 Adverse Events	Adverse event per NIH/DAIDS criteria	48 weeks
Secondary	CD4 T-cell Count at 48 Weeks < Baseline		48 weeks
Secondary	< 50 CD4 T-cell Increase at 48 Weeks From Baseline		48 weeks
Secondary	Switching Off Stribild Prior to 48 Weeks		48 Weeks
Secondary	Development of Drug Resistance Mutations to Elvitegravir or Emtricitabine or Tenofovir DF		48 weeks