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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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HIV/AIDS

Intervention / Treatment
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* Drug: bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF)
* Drug: Standard initiation of antiretroviral therapy (ART)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm A: Rapid Start Group<br>Same day antiretroviral therapy (ART) with bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF) + new diagnosis package with laboratory evaluations and social work referral. | Drug: bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF)<br>* A 30 day supply of Bictegravir 50mg/Emtricitabine 200mg/Tenofovir Alafenamide 25mg will be provided to the rapid start arm.<br>* Other names: Biktarvy;|
| Placebo Comparator: Arm B: Standard Group<br>Standard initiation of ART at the discretion of provider + new diagnosis package with laboratory evaluations and social work referral. | Drug: Standard initiation of antiretroviral therapy (ART)<br>* Standard initiation of ART at the discretion of provider + new diagnosis package with laboratory evaluations and social work referral.<br>* Other names: Standard of Care ART;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viral Suppression | Proportion of participants with viral suppression to <50 copies/mL at 48 weeks by FDA snapshot in the rapid-start ART arm compared to the standard of care arm. | 48 weeks |