Antiretroviral

PrEP for HIV (Human Immunodeficiency Virus)

Phase 4
Recruiting
Led By Hansel Tookes
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
speak either English or Spanish
Be older than 18 years old
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upup to 12 months
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
Approved for 10 Other Conditions
No Placebo-Only Group
All Individual Drugs Already Approved

Study Summary

This trial will test if providing HIV-negative participants with PrEP medicine at the IDEA Exchange will help them stay negative.

Eligible Conditions
  • HIV (Human Immunodeficiency Virus)
  • Substance Use Disorder

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
Select...
You must be able to speak either English or Spanish.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Intracellular level of tenofovir diphosphate
Secondary outcome measures
time to PrEP initiation post negative HIV rapid test

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Rapid PrEP groupExperimental Treatment2 Interventions
Participants will receive PrEP i.e. Descovy for 12 months at the syringe services program.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PrEP
2018
Completed Phase 4
~9130

Find a site

Who is running the clinical trial?

University of MiamiLead Sponsor
856 Previous Clinical Trials
383,837 Total Patients Enrolled
Hansel TookesPrincipal Investigator
University of Miami

Media Library

Descovy (Antiretroviral) Clinical Trial Eligibility Overview. Trial Name: NCT04782180 — Phase 4
HIV (Human Immunodeficiency Virus) Research Study Groups: Rapid PrEP group
HIV (Human Immunodeficiency Virus) Clinical Trial 2023: Descovy Highlights & Side Effects. Trial Name: NCT04782180 — Phase 4
Descovy (Antiretroviral) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04782180 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current size of the cohort taking part in this research?

"Affirmative. According to information published on clinicaltrials.gov, this medical research has been actively searching for participants since February 1st 2022 and was most recently updated in March 4th 2022. The trial needs 100 individuals at a single site."

Answered by AI

Are there still openings available for participants in this research?

"The details posted on clinicaltrials.gov demonstrate that this medical investigation is enrolling participants, with the initial announcement made on February 1st 2022 followed by a recent update on March 4th."

Answered by AI

What research has been conducted related to PrEP?

"Currently, 98 clinical trials are underway to investigate the efficacy of PrEP with 22 in its final phase. The epicentre of these trials is Boylston, Massachusetts but there are 1610 global locations carrying out research."

Answered by AI

What potential risks come with taking PrEP?

"PrEP has already been approved, making it a safe and viable option. Our team at Power gave this treatment an assessment score of 3 to reflect its efficacy in the medical community."

Answered by AI

What pathologies is PrEP typically employed to combat?

"The antiretroviral drug PrEP can be utilized to treat HIV-1, address existing infections caused by the virus, and reduce transmission."

Answered by AI

Who else is applying?

What state do they live in?
Florida
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
PrEP at a Syringe Services Program
Hansel Tookes 2022. "PrEP at a Syringe Services Program". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04782180.
~30 spots leftby May 2024
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