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

NCT02180438 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: STUDY00000757
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

HIV-2 Infection

Keywords

HIV-2

Outcome Measures

Primary Outcomes (3)

• Death

  Number of Participants Experiencing Death within the study period

  48 weeks

• New WHO Stage 3 or 4 Event

  New AIDS defining event per WHO criteria

  48 weeks

• Virologic Failure, FDA Snapshot (HIV-2 Plasma Viral Load >50 and >400 Copies/ml)

  48 weeks

Secondary Outcomes (5)

• Grade 3 or 4 Adverse Events

  48 weeks

• CD4 T-cell Count at 48 Weeks < Baseline

  48 weeks

• < 50 CD4 T-cell Increase at 48 Weeks From Baseline

  48 weeks

• Switching Off Stribild Prior to 48 Weeks

  48 Weeks

• Development of Drug Resistance Mutations to Elvitegravir or Emtricitabine or Tenofovir DF

  48 weeks

Other Outcomes (4)

• Interim 24 Weeks Analysis of Death

  24 weeks

• Interim Analysis at 24 Weeks of New WHO Stage 3 or 4 Event

  24 weeks

• Interim Analysis at 24 Weeks of HIV-2 Virologic Failure

  24 weeks

Study Arms (1)

Open label prospective single arm study of Stribild

EXPERIMENTAL

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

Interventions

Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF) 1 tablet daily X 48 weeks DRUG

Open label prospective single arm study of Stribild

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Washington: lead
• Clinique des Maladies Infectieuses Ibrahima DIOP Mar/CRCF, Centre Hospitalier Universitaire de Fann: collaborator
• Gilead Sciences: collaborator

Study Sites (1)

Clinique des Maladies Infectieuses Ibrahima DIOP Mar/CRCF, Centre Hospitalier Universitaire de Fann

Dakar, Senegal

Location

Related Publications (1)

• Ba S, Raugi DN, Smith RA, Sall F, Faye K, Hawes SE, Sow PS, Seydi M, Gottlieb GS; University of Washington-Dakar HIV-2 Study Group. 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. Clin Infect Dis. 2018 Oct 30;67(10):1588-1594. doi: 10.1093/cid/ciy324.

  PMID: 29672676 DERIVED

MeSH Terms

Interventions

Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; elvitegravir; Cobicistat

Intervention Hierarchy (Ancestors)

Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Tenofovir; Organophosphonates; Organophosphorus Compounds; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Emtricitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Geoffrey S Gottlieb. MD PhD (PI)
• Organization: University of Washington

gottlieb@uw.edu

1-206-616-2631

Study Officials

• Geoffrey S Gottlieb, MD PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

• Moussa Seydi, MD

  Clinique des Maladies Infectieuses Ibrahima DIOP Mar/CRCF, Centre Hospitalier Universitaire de Fann

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Medicine

Study Record Dates

• First Submitted: May 29, 2014
• First Posted: July 2, 2014
• Study Start: September 1, 2014
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: July 26, 2018
• Results First Posted: May 8, 2018

Record last verified: 2018-06

Locations

SE (1)