Clinical trial NCT04249037: Rapid Start vs. Standard Start Antiretroviral Therapy (ART) in HIV
Official title: Prospective Pilot Study of the Efficacy, Safety and Tolerability of Bictegravir-Based HIV ART Same-Day Treatment Evaluations (B-HASTE)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: HIV/AIDS
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2020-01-30
Enrollment: 10
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Randomized two arm, multi-site (three sites), open label pilot study conducted with laboratory evaluation and visits at entry, 4 weeks, 12 weeks, 24 weeks, 48 weeks and 96 weeks with laboratory evaluations and assessment if participants remain engaged in care.

Participants will be randomly assigned with equal probability to one of two arms:

Arm A: Same day antiretroviral therapy (ART) with bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF) + new diagnosis package with laboratory evaluations and social work referral.

Arm B: Standard initiation of ART at the discretion of provider + new diagnosis package with laboratory evaluations and social work referral.

Eligibility 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

Primary outcomes:
measure: Viral Suppression
timeFrame: 48 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Anschutz
state: Colorado
city: Omaha
country: United States
facility: University of Nebraska
state: Nebraska
Study officials:
affiliation: University of Colorado, Denver
name: Hillary Dunlevy, MD
role: PRINCIPAL_INVESTIGATOR
References: