Last updated: November 27, 2023
Sponsor: University of Colorado, Denver
Overall Status: Terminated
Phase
4
Condition
Hiv Infections
Aids And Aids Related Infections
Hiv/aids
Treatment
bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF)
Standard initiation of antiretroviral therapy (ART)
Clinical Study ID
NCT04249037
19-0829
Ages > 15 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Men and women 15 years and older in Colorado and 19 years and older in Nebraska. Awaiver of parental consent is planned for individuals 15-17 in accordance withColorado law which allows minors to consent for treatment for sexually transmittedinfections, including HIV.
- Reactive HIV-1 on an approved fourth generation HIV-1 antibody/antigen test within 72hours
- Any primary language with access to an interpreter by phone is included.
Exclusion
Exclusion Criteria:
- Pregnancy or intention to become pregnant in the next two years after enrollment
- Symptomatic acute HIV (with fever, rash, influenza-like symptoms)
- Creatinine clearance <30 mL/min by Cockcroft-Gault equation. (Therapy initiated willbe terminated promptly in individuals who are found to have creatinine clearance <30mL/min)
- Prior history of known HIV diagnosis
- Negative confirmatory HIV differentiation assays (therapy initiated will be terminatedin individuals with negative tests and excluded from the primary analysis)
- Allergy to bictegravir, emtricitabine or tenofovir alafenamide
- Signs or symptoms of opportunistic infection with cryptococcal meningitis,tuberculosis or other infection that requires delay of initiation of antiretroviraltherapy (up to the discretion of the site PI)
- Vulnerable populations including prisoners and individuals without decision makingcapacity
- Concommitant use of medications that are contraindicated with bictegravir,emtricitabine and tenofovir alafenamide including adefovir, carbamazepine, cladribine,dofetilide, fosphenytoin-phenytoin, oxcarbazepine, phenobarbital, primidone, rifampin,rifabutin, rifapentine, St. John's Wort, tipranavir
Study Design
Total Participants: 10
Treatment Group(s): 2
Primary Treatment: bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF)
Phase: 4
Study Start date:
December 15, 2020
Estimated Completion Date:
July 01, 2023
Study Description
Connect with a study center
Children's Hospital Colorado
Aurora, Colorado 80045
United StatesSite Not Available
University of Colorado Anschutz
Aurora, Colorado 80045
United StatesSite Not Available
University of Nebraska
Omaha, Nebraska 68198
United StatesSite Not Available
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