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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02180438 |
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Date of registration:
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29/05/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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An Open Label Trial of Stribild for Antiretroviral (ARV)-naïve HIV-2 Infected Adults in Dakar, Senegal
Stribild HIV-2 |
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Scientific title:
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An Open Label Trial of STRIBILD™ (Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate) for ARV-naïve HIV-2 Infected Adults in Dakar, Senegal |
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Date of first enrolment:
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September 2014 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02180438 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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Senegal
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Contacts
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Name:
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Geoffrey S Gottlieb, MD PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Washington |
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Name:
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Moussa Seydi, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Clinique des Maladies Infectieuses Ibrahima DIOP Mar/CRCF, Centre Hospitalier Universitaire de Fann |
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Key inclusion & exclusion criteria
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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)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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HIV-2 Infection
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Intervention(s)
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Drug: Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF) 1 tablet daily X 48 weeks
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Primary Outcome(s)
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Virologic Failure, FDA Snapshot (HIV-2 Plasma Viral Load >50 and >400 Copies/ml)
[Time Frame: 48 weeks]
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Death
[Time Frame: 48 weeks]
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New WHO Stage 3 or 4 Event
[Time Frame: 48 weeks]
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Secondary Outcome(s)
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< 50 CD4 T-cell Increase at 48 Weeks From Baseline
[Time Frame: 48 weeks]
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CD4 T-cell Count at 48 Weeks < Baseline
[Time Frame: 48 weeks]
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Grade 3 or 4 Adverse Events
[Time Frame: 48 weeks]
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Switching Off Stribild Prior to 48 Weeks
[Time Frame: 48 Weeks]
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Development of Drug Resistance Mutations to Elvitegravir or Emtricitabine or Tenofovir DF
[Time Frame: 48 weeks]
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Secondary ID(s)
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STUDY00000757
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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