Rapid ART Initiation for HIV at Syringe Services Programs

Overseen by Hansel Tookes, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: University of Miami

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of this study is to see if providing HIV medicine right away at the IDEA Syringe Services Program will help the participant start and remain in HIV care, including having no detectable HIV in the participant's blood.

Research Team

Hansel Tookes, MD

Principal Investigator

University of Miami

Eligibility Criteria

This trial is for adults over 18 who inject drugs, are living with HIV, and have a viral load above 200 copies/ml. They must be able to consent, have no allergies to Biktarvy's components, and sufficient kidney function (creatinine clearance >30 mg/dl). People with other serious health issues may not qualify.

Inclusion Criteria

HIV RNA > 200 copies/ml

I am over 18 years old.

I am not allergic to bictegravir/emtricitabine/tenofovir alafenamide.

Exclusion Criteria

The doctor may exclude you from the study if you have any other serious health conditions.

Treatment Details

Interventions

• Biktarvy 50Mg-200Mg-25Mg Tablet (Antiretroviral Therapy)

Trial Overview The study tests if starting HIV treatment immediately at the IDEA Syringe Services Program improves care engagement and reduces HIV levels in blood. Participants will receive Biktarvy tablets and integrated HIV care services.

Participant Groups

Group I: Rapid ART group Experimental Treatment 2 Interventions

Patients will receive HIV care including Biktarvy for 6 months at the syringe services program followed by 6 months of standard of care at a traditional clinic.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Sylvia Daunert

University of Miami

Chief Executive Officer since 2011

PhD in Biochemistry and Molecular Biology, University of Kentucky

Bahar Motlagh

University of Miami

Chief Medical Officer since 2021

PhD in Biomedical Engineering, Ecole Polytechnique Montreal

Gilead Sciences

Industry Sponsor

Trials

1,150

Recruited

878,000+

Daniel O'Day

Gilead Sciences

Chief Executive Officer since 2019

MBA from Columbia University

Dietmar Berger

Gilead Sciences

Chief Medical Officer

MD and PhD from Albert-Ludwigs University School of Medicine