Recruiting
Phase 1

F/TAF Tablets

Sponsor:

Johns Hopkins University

Code:

NCT07349758

Conditions

Healthy Volunteer

HIV Prevention

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

tenofovir alafenamide [TAF] 50 mg/emtricitabine [FTC] 400mg

Study Details

Brief summary:

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

Healthy Volunteer

HIV Prevention

Study ID

NCT07349758

Start date

Jan 6, 2026

Status verified date

Feb, 2026

Completion date

Jan 1, 2028

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • ≥18 years of age, inclusive on the date of screening
  • Provides written informed consent for the study
  • Good general health, as determined by medical history, physical examination, vital signs, screening laboratory tests
  • Non-reactive HIV test results within four weeks of enrollment
  • An estimated glomerular filtration rate (eGFR) of ≥ 70 mL/min/1.73 m2 via the CKD-EPI 2021 eGFRCr equation
  • Agrees to use condoms for all sexual events during study participation
  • Willing to abstain from oral PrEP use outside of study products for the duration of the study

Exclusion Criteria:

  • History of oral PrEP (F/TDF or F/TAF) use in the preceding two months
  • Persons who have a reactive or positive HIV result from screening visit.
  • Positive hepatitis B surface antigen (HBsAg) test
  • Participants with a history of having a gastrectomy, colostomy, ileostomy, or any other procedure altering the gastrointestinal tract or drug absorption
  • History of any behaviors that place the participant at high-risk for HIV acquisition (e.g., needle sharing, unprotected sex with ≥1 partner in the prior 2 weeks)
  • Taking concomitant medications that that are known inducers/inhibitors of P-gp that would effect TAF absorption
  • Pregnancy or lactation
  • Any other condition or prior therapy that, in the opinion of the investigator, would preclude informed consent, make study participation unsafe, make the individual unsuitable for the study or unable to comply with the study requirements. Such conditions may include, but are not limited to, current or recent history of severe, progressive, or uncontrolled substance abuse, or renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, or cerebral disease

Study Design

Enrollment

24 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: F/TAF dosing

Received one-time dosing of two F/TAF tablets

Interventions

tenofovir alafenamide [TAF] 50 mg/emtricitabine [FTC] 400mg

One-time dose of two F/TAF tablets

Primary outcome measure

  • Intracellular tenofovir-diphosphate concentrations (fmol/10^6) [ Time Frame: 168 hours ]

Central Contacts and Locations

Central contacts

Jennifer Hoffmann, CRNP

410-955-1318jhoffm45@jh.edu

Pooja Akoijam, MD

410-955-1201pakoija1@jh.edu

Locations

Johns Hopkins University School of Medicine

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Jennifer Hoffmann, CRNP

410-955-1318jhoffm45@jh.edu

Pooja Akoijam, MD

410-955-1201pakoija1@jh.edu

More Information

Sponsor

Johns Hopkins University

Last update posted

Feb 13, 2026

Last verified

Feb, 2026

Keywords

  • HIV PrEP
  • healthy volunteer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-09. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-02-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.