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

Last updated: November 27, 2023
Sponsor: University of Colorado, Denver
Overall Status: Terminated

Phase

4

Condition

Hiv Infections

Aids And Aids Related Infections

Hiv/aids

Treatment

bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF)

Standard initiation of antiretroviral therapy (ART)

Clinical Study ID

NCT04249037
19-0829
  • Ages > 15
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Men and women 15 years and older in Colorado and 19 years and older in Nebraska. Awaiver of parental consent is planned for individuals 15-17 in accordance withColorado law which allows minors to consent for treatment for sexually transmittedinfections, including HIV.
  • Reactive HIV-1 on an approved fourth generation HIV-1 antibody/antigen test within 72hours
  • Any primary language with access to an interpreter by phone is included.

Exclusion

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 willbe terminated promptly in individuals who are found to have creatinine clearance <30mL/min)
  • Prior history of known HIV diagnosis
  • Negative confirmatory HIV differentiation assays (therapy initiated will be terminatedin 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 antiretroviraltherapy (up to the discretion of the site PI)
  • Vulnerable populations including prisoners and individuals without decision makingcapacity
  • 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 Design

Total Participants: 10
Treatment Group(s): 2
Primary Treatment: bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF)
Phase: 4
Study Start date:
December 15, 2020
Estimated Completion Date:
July 01, 2023

Study 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.

Connect with a study center

  • Children's Hospital Colorado

    Aurora, Colorado 80045
    United States

    Site Not Available

  • University of Colorado Anschutz

    Aurora, Colorado 80045
    United States

    Site Not Available

  • University of Nebraska

    Omaha, Nebraska 68198
    United States

    Site Not Available

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