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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04249037
Recruitment Status : Not yet recruiting
First Posted : January 30, 2020
Last Update Posted : January 30, 2020
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
University of Colorado, Denver

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.

Condition or disease Intervention/treatment Phase
HIV/AIDS Drug: bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF) Drug: Standard initiation of antiretroviral therapy (ART) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
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)
Estimated Study Start Date : March 1, 2020
Estimated Primary Completion Date : March 1, 2022
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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 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




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04249037


Contacts
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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
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Principal Investigator: Hillary Dunlevy, MD University of Colorado, Denver
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT04249037    
Other Study ID Numbers: 19-0829
First Posted: January 30, 2020    Key Record Dates
Last Update Posted: January 30, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Tenofovir
Emtricitabine
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents