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

Primary Purpose

HIV/AIDS

Status
Active
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF)
Standard initiation of antiretroviral therapy (ART)
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV/AIDS

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Children's Hospital Colorado
  • University of Colorado Anschutz
  • University of Nebraska

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm A: Rapid Start Group

Arm B: Standard Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 28, 2020
Last Updated
April 18, 2023
Sponsor
University of Colorado, Denver
Collaborators
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04249037
Brief Title
Rapid Start vs. Standard Start Antiretroviral Therapy (ART) in HIV
Acronym
B-HASTE
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 15, 2020 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
Gilead Sciences

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A: Rapid Start Group
Arm Type
Active Comparator
Arm Description
Same day antiretroviral therapy (ART) with bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF) + new diagnosis package with laboratory evaluations and social work referral.
Arm Title
Arm B: Standard Group
Arm Type
Placebo Comparator
Arm Description
Standard initiation of ART at the discretion of provider + new diagnosis package with laboratory evaluations and social work referral.
Intervention Type
Drug
Intervention Name(s)
bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF)
Other Intervention Name(s)
Biktarvy
Intervention Description
A 30 day supply of Bictegravir 50mg/Emtricitabine 200mg/Tenofovir Alafenamide 25mg will be provided to the rapid start arm.
Intervention Type
Drug
Intervention Name(s)
Standard initiation of antiretroviral therapy (ART)
Other Intervention Name(s)
Standard of Care ART
Intervention Description
Standard initiation of ART at the discretion of provider + new diagnosis package with laboratory evaluations and social work referral.
Primary Outcome Measure Information:
Title
Viral Suppression
Description
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.
Time Frame
48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hillary Dunlevy, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Colorado Anschutz
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Nebraska
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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