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Antiretroviral Therapy
Rapid ART Initiation for HIV at Syringe Services Programs
Phase 4
Waitlist Available
Led By Hansel Tookes, MD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adult (age>18 years);
no allergy to bictegravir/emtricitabine/tenofovir alafenamide (BFTAF) as indicated by patient history and self-reported allergies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study Summary
This trial will test if providing HIV medicine immediately at an IDEA Syringe Services Program will help people with HIV get and stay in care, including having no detectable HIV in their blood.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Biktarvy may cause side effects like headache, diarrhea, nausea, fatigue and can sometimes affect liver enzymes or kidney function. Rarely it might lead to severe allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am over 18 years old.
Select...
I am not allergic to bictegravir/emtricitabine/tenofovir alafenamide.
Select...
I am over 18 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Percentage of participants with HIV viral load suppression
Trial Design
1Treatment groups
Experimental Treatment
Group I: Rapid ART groupExperimental Treatment2 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biktarvy 50Mg-200Mg-25Mg Tablet
2021
Completed Phase 4
~30
Find a Location
Who is running the clinical trial?
University of MiamiLead Sponsor
899 Previous Clinical Trials
409,705 Total Patients Enrolled
Hansel Tookes, MD5.01 ReviewsPrincipal Investigator - University of Miami
University of Miami
1 Previous Clinical Trials
350 Total Patients Enrolled
5Patient Review
This doctor is amazing — they really make sure you stay healthy and care a lot for their patients.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am over 18 years old.I am not allergic to bictegravir/emtricitabine/tenofovir alafenamide.I am over 18 years old.The doctor may exclude you from the study if you have any other serious health conditions.
Research Study Groups:
This trial has the following groups:- Group 1: Rapid ART group
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Human Immunodeficiency Virus Infection Patient Testimony for trial: Trial Name: NCT04650269 — Phase 4
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research initiative currently recruiting participants?
"Affirmative. Perusal of the information available on clinicaltrials.gov reveals that this experiment is presently recruiting candidates, beginning from March 4th 2021 and concluding on May 4th 2022. 50 participants are sought after in a single medical centre."
Answered by AI
Are there any past studies that have focused on HIV treatment?
"Currently, 98 medical trials for HIV care are ongoing with the majority of Phase 3 studies located in Boylston, MA. Across 1610 sites worldwide these clinical experiments are being conducted."
Answered by AI
What medical issues are typically treated with HIV care?
"Anti-retroviral agents are a major component of HIV care, and this type of treatment has been demonstrated to be effective for patients who have yet to receive medication, lack resistance to darunavir, or suffer from HIV-1."
Answered by AI
How many participants have voluntarily joined this trial?
"Indeed, information hosted on clinicaltrials.gov indicates that this research trial is actively enrolling participants and was first posted on March 4th 2021. The study aims to recruit 50 patients from a single medical site."
Answered by AI
To what extent does providing HIV care pose risks to individuals?
"The safety of HIV care has been verified in Phase 4 trials and thus earned a rating of 3."
Answered by AI
Who else is applying?
What state do they live in?
Nevada
Florida
What site did they apply to?
University of Miami
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
1
Why did patients apply to this trial?
Quiero mejorar mi condicion fisica. Because I want to help the study of this virus as much as I can so that people just as young as me do not go through the same thing and the contagion of this virus can be eliminated as much as possible.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
How long is it going to take? Will I ever have to be hospitalized? I work in the morning during the week, can I study in the afternoon?
PatientReceived 1 prior treatment
How responsive is this trial?
Typically responds via
Phone Call
Most responsive sites:
- University of Miami: < 24 hours
Average response time
- < 1 Day
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