Prospective Pilot Study of the Efficacy, Safety and Tolerability of Bictegravir-Based HIV ART Same-Day Treatment Evaluations (B-HASTE)

19-0829

This study plans to learn about whether starting HIV treatment very soon after diagnosis is more beneficial than waiting until entering routine clinical care after diagnosis.

2020-12-15

2023-07-01

2023-07-01

Terminated

Early phase I

10

Inclusion Criteria: * Men and women 15 years and older in Colorado and 19 years and older in Nebraska. A waiver of parental consent is planned for individuals 15-17 in accordance with Colorado law which allows minors to consent for treatment for sexually transmitted infections, including HIV. * Reactive HIV-1 on an approved fourth generation HIV-1 antibody/antigen test within 72 hours * Any primary language with access to an interpreter by phone is included. 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 will be terminated promptly in individuals who are found to have creatinine clearance \<30 mL/min) * Prior history of known HIV diagnosis * Negative confirmatory HIV differentiation assays (therapy initiated will be terminated in 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 antiretroviral therapy (up to the discretion of the site PI) * Vulnerable populations including prisoners and individuals without decision making capacity * 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 10, 'type': 'ACTUAL'}}

2023-11-30