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

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

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.

Study Overview

• Status: Terminated
• Conditions: HIV/AIDS
• Intervention / Treatment: Drug: bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF); Drug: Standard initiation of antiretroviral therapy (ART)

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Hillary Dunlevy, MD; Phone Number: 303-724-9307; Email: hillary.dunlevy@cuanschutz.edu
• Study Contact Backup: Name: Suzanne Fiorillo, MSPH; Phone Number: 303-724-5931; Email: suzanne.fiorillo@cuanschutz.edu

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Children's Hospital Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Anschutz
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm A: Rapid Start Group; 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); A 30 day supply of Bictegravir 50mg/Emtricitabine 200mg/Tenofovir Alafenamide 25mg will be provided to the rapid start arm.; Other Names: Biktarvy
Placebo Comparator: Arm B: Standard Group; 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); Standard initiation of ART at the discretion of provider + new diagnosis package with laboratory evaluations and social work referral.; Other Names: Standard of Care ART

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: Gilead Sciences
• Investigators: Principal Investigator: Hillary Dunlevy, MD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2020
• Primary Completion (Actual): July 1, 2023
• Study Completion (Actual): July 1, 2023

Study Registration Dates

• First Submitted: January 28, 2020
• First Submitted That Met QC Criteria: January 28, 2020
• First Posted (Actual): January 30, 2020

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; Urogenital Diseases; Genital Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Tenofovir; Emtricitabine; Emtricitabine tenofovir alafenamide; Anti-Retroviral Agents
• Other Study ID Numbers: 19-0829

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No