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

University of Colorado Denver (CU Denver)

Status and phase: Terminated; Phase 4

Conditions: HIV/AIDS

Treatments: Drug: bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF); Drug: Standard initiation of antiretroviral therapy (ART)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04249037

19-0829

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups, including a placebo group

Arm A: Rapid Start Group

Active Comparator group

Description:

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

Treatment:

Drug: bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF)

Arm B: Standard Group

Placebo Comparator group

Description:

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

Treatment:

Drug: Standard initiation of antiretroviral therapy (ART)