NCT04650269

Implementation of Onsite, Rapid ART Initiation Among People Who Inject Drugs Living With HIV at Syringe Services Program

Completed Phase 4 Results posted Last updated 8 January 2025

What this trial tests

Phase 4 trial testing Biktarvy 50Mg-200Mg-25Mg Tablet in Harm Reduction in 27 participants. Completed in 31 December 2023.

Timeline

4 March 2021

Primary endpoint
31 December 2023

31 December 2023

Quick facts

Lead sponsor	University of Miami
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	27
Start date	4 March 2021
Primary completion	31 December 2023
Estimated completion	31 December 2023
Sites	1 location across United States

Drugs / interventions tested

• Biktarvy 50Mg-200Mg-25Mg Tablet — full drug profile →
• HIV care

Conditions studied

• Harm Reduction — all drugs for Harm Reduction →
• HIV Infections — all drugs for HIV Infections →
• Drug Use — all drugs for Drug Use →

Sponsor

University of Miami

Who can join

18 and older, any sex, with Harm Reduction or HIV Infections. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants With HIV Viral Load Suppression Primary · 6 months

HIV viral load suppression is defined as \<200 copies/ml in participants' blood

Group	Value	95% CI
Rapid ART Group	11

Percentage of Participants With HIV Viral Load Suppression Secondary · 1 month

HIV viral load suppression is defined as \<200 copies/ml in participants' blood

Group	Value	95% CI
Rapid ART Group	11

Percentage of Participants With HIV Viral Load Suppression Secondary · 12 months

HIV viral load suppression is defined as \<200 copies/ml in participants' blood

Group	Value	95% CI
Rapid ART Group	15

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 year. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Rapid ART Group

Serious: 3/27 (11%)

Deaths: 3/27

Serious adverse events (1 terms)

Reaction	System	Rapid ART Group
death	Respiratory, thoracic and mediastinal disorders	—

Most-reported serious reactions: death.

Data from ClinicalTrials.gov NCT04650269 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.