Actively Recruiting
Pharmacokinetic Evaluation of Single Dosing With Two F/TAF Tablets for HIV Prevention Among Healthy Volunteers
Led by Johns Hopkins University · Updated on 2026-02-13
24
Participants Needed
1
Research Sites
52 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
Researchers are studying how a single dose of two F/TAF tablets behaves in the body over a 14-day period to better understand HIV prevention using oral pre-exposure prophylaxis (PrEP). This study focuses on measuring the levels of the drugs tenofovir alafenamide (TAF), tenofovir (TFV), and emtricitabine (FTC), as well as their active forms inside cells, to explore if less frequent dosing could be effective for preventing HIV. Participants will receive a one-time double dose consisting of two tablets of Descovy, which contains tenofovir alafenamide 25 mg and emtricitabine 200 mg each. After taking the dose, they will be followed closely with intensive blood sampling initially, which becomes less frequent over the next 14 days to analyze the drugs' behavior in the body. This study is a phase 1 trial focused on healthy volunteers. During the 14-day follow-up, participants will undergo pharmacokinetic assessments to measure intracellular tenofovir-diphosphate concentrations at various time points. The study includes medical history reviews, physical exams, vital signs, laboratory tests including HIV and hepatitis B screening, and monitoring for safety. The goal is to collect detailed data on how the drugs are processed and maintained in the body to inform future dosing strategies for HIV prevention.
CONDITIONS
Brief 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 screening
- Provides written informed consent
- Good general health based on medical history, physical exam, vital signs, and lab tests
- Non-reactive HIV test within 4 weeks before enrollment
- 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 oral PrEP outside study products during the trial
You will not qualify if you...
- Use of oral PrEP (F/TDF or F/TAF) in the last 2 months
- Positive or reactive HIV test at screening
- Positive hepatitis B surface antigen test
- History of gastrectomy, colostomy, ileostomy, or other procedures altering the gastrointestinal tract or drug absorption
- Recent high-risk behaviors for HIV (e.g., needle sharing, unprotected sex with one or more partners in prior 2 weeks)
- Use of medications that affect TAF absorption via P-gp induction or inhibition
- Pregnancy or breastfeeding
- Any condition or therapy that makes participation unsafe or unsuitable, including recent severe or uncontrolled substance abuse or serious organ diseases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 14 days
Participants receive a one-time dose of two F/TAF tablets and undergo intensive pharmacokinetic monitoring.
Multiple visits for pharmacokinetic sampling over 14 days
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
P
Pooja Akoijam, MD
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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