Actively Recruiting
Evaluation of Single Dosing With Two F/TAF Tablets Among Healthy Volunteers
Led by Johns Hopkins University · Updated on 2026-02-13
24
Participants Needed
1
Research Sites
103 weeks
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
N
National Institute on Drug Abuse (NIDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this study is to evaluate the pharmacokinetics of a one-time dosing of two F/TAF tablets over a 14-day period.
CONDITIONS
Official Title
Evaluation of Single Dosing With Two F/TAF Tablets Among Healthy Volunteers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older at the time of screening
- Provides written informed consent to participate
- In good general health based on medical history, physical exam, vital signs, and lab tests
- Has a non-reactive HIV test result within 4 weeks before enrollment
- Has an estimated glomerular filtration rate (eGFR) of 70 mL/min/1.73 m2 or higher
- Agrees to use condoms for all sexual activity during the study
- Willing to avoid using oral PrEP outside of study treatment during the study period
You will not qualify if you...
- History of oral PrEP use (F/TDF or F/TAF) within the past 2 months
- Positive or reactive HIV test at screening
- Positive test for hepatitis B surface antigen
- History of surgeries altering gastrointestinal tract or drug absorption (e.g., gastrectomy, colostomy, ileostomy)
- History of high-risk behaviors for HIV acquisition in the prior 2 weeks (e.g., needle sharing, unprotected sex with 1 or more partners)
- Taking medications that affect TAF absorption through P-gp induction or inhibition
- Pregnant or breastfeeding
- Any condition or prior therapy that would make participation unsafe, unsuitable, or prevent informed consent, including severe or uncontrolled substance abuse or serious organ diseases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21287
Actively Recruiting
Research Team
J
Jennifer Hoffmann, CRNP
CONTACT
P
Pooja Akoijam, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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