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

NCT ID: NCT04249037

Last Updated: 2023-11-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-15
• Study Completion Date: 2023-07-01

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.

Conditions

HIV/AIDS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

A 30 day supply of Bictegravir 50mg/Emtricitabine 200mg/Tenofovir Alafenamide 25mg will be provided to the rapid start arm.

Arm B: Standard Group

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

Group Type: PLACEBO_COMPARATOR

Standard initiation of antiretroviral therapy (ART)

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Biktarvy; Standard of Care ART

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

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hillary Dunlevy, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

Children's Hospital Colorado

Aurora, Colorado, United States

University of Colorado Anschutz

Aurora, Colorado, United States

University of Nebraska

Omaha, Nebraska, United States

Countries

United States

Other Identifiers

19-0829

Identifier Type: -

Identifier Source: org_study_id