Rapid Start vs. Standard Start Antiretroviral Therapy (ART) in HIV

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Colorado, Denver
• Collaborator: Gilead Sciences
• Treatments: Anti-Retroviral Agents; Emtricitabine; Emtricitabine tenofovir alafenamide; Tenofovir

Criteria

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