NCT04249037

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

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV/AIDS

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2020-12-15
• Primary completion: 2023-07-01
• Completion: 2023-07-01
• First posted: 2020-01-30
• Last updated: 2023-11-30

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study