Clinical Trials

MainTitle

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

This study is not yet open for participant recruitment. (see Contacts and Locations)

Verified January 2020 by University of Colorado, Denver

Sponsor
University of Colorado, Denver

Collaborator
Gilead Sciences

Information provided by (Responsible Party)
University of Colorado, Denver
ClinicalTrials.gov Identifier
NCT04249037

First received: January 28, 2020
Last updated: January 28, 2020
Last Verified: January 2020
History of Changes
Purpose

Purpose

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.

Condition Intervention
HIV/AIDS

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Pilot Study of the Efficacy, Safety and Tolerability of Bictegravir-Based HIV ART Same-Day Treatment Evaluations (B-HASTE)

Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures

  • Viral Suppression [ Time Frame: 48 weeks ]
    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.

Estimated Enrollment: 100
Study Start Date: March 1, 2020
Estimated Study Completion Date: December 1, 2022
Estimated Primary Completion Date: March 1, 2022 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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 Name: 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 Name: Standard of Care 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.

Eligibility

Eligibility

Ages Eligible for Study: 15 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT04249037

Contacts

Contact:   Hillary Dunlevy, MD 303-724-9307 hillary.dunlevy@cuanschutz.edu
Contact:   Suzanne Fiorillo, MSPH 303-724-5931 suzanne.fiorillo@cuanschutz.edu

Sponsors and Collaborators

University of Colorado, Denver
Gilead Sciences

Investigators

Principal Investigator: Hillary Dunlevy, MD University of Colorado, Denver
More Information

More Information


Responsible Party: University of Colorado, Denver  
ClinicalTrials.gov Identifier: NCT04249037   History of Changes  
Other Study ID Numbers: 19-0829  
Study First Received: January 28, 2020  
Last Updated: January 28, 2020  
Individual Participant Data    
Plan to Share IPD: No  

Studies a U.S. FDA-regulated Drug Product: No  
Studies a U.S. FDA-regulated Device Product: No  
Product Manufactured in and Exported from the U.S.: No  

Additional relevant MeSH terms:
Tenofovir
Emtricitabine
Anti-Retroviral Agents

ClinicalTrials.gov processed this data on June 01, 2020
This information is provided by ClinicalTrials.gov.