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Clinical trial Recruiting at 1 site Phase 1 Interventional Ages 18 and up

One-time double dose of Descovy (F/TAF) in healthy adults

Official title: DD-PrEP: Pharmacokinetic Evaluation of Single Dosing With Two F/TAF Tablets Among Healthy Volunteers

Run by Johns Hopkins University · NCT07349758 · Data updated 2026-11-12

We will test a one-time double dose of two F/TAF (Descovy) tablets in healthy adults to see how long drug levels remain over 14 days for HIV PrEP.

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Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment24 (estimated)
SponsorJohns Hopkins University
Academic / other
Locations1 site (Baltimore, Maryland)
StatusRecruiting
StartedJanuary 6, 2026
Main results expectedJanuary 1, 2027
Study endsJanuary 1, 2028
Registry record updatedFebruary 13, 2026
Trial IDNCT07349758 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Healthy adults aged 18 or older who are HIV-negative, have adequate kidney function (eGFR ≥70 mL/min/1.73 m2), have not used oral PrEP in the prior two months, and can attend frequent blood-draw visits and use condoms during the study.

Probably not a fit

People living with HIV, those with positive hepatitis B surface antigen, significant renal impairment, recent oral PrEP use, or prior gastrointestinal surgeries that alter absorption are unlikely to benefit or be eligible.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 trial gives a single double dose (two tablets) of F/TAF (tenofovir alafenamide 50 mg/emtricitabine 400 mg) to healthy, HIV-negative adults and follows them for 14 days. Intensive pharmacokinetic sampling occurs immediately after dosing and becomes less frequent over the two-week follow-up to measure plasma and intracellular levels of TAF, tenofovir, FTC and their metabolites. The pharmacokinetic profiles will be used to inform the plausibility of alternate, less-frequent dosing regimens for oral PrEP. Enrollment requires good general health, adequate renal function, and agreement to use condoms and avoid other oral PrEP during the study.

Why it matters

Potential benefit: If successful, the results could support less-frequent dosing options for oral PrEP, potentially improving convenience and adherence.

How similar studies have gone: Daily tenofovir-containing regimens (including Descovy) are effective for PrEP, but single-dose or intermittent double-dose approaches are largely untested and remain exploratory.

Who can join: the full rules

Show full inclusion / exclusion criteria 
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

Where it's running

  • Johns Hopkins University School of Medicine
    Baltimore, Maryland, United States     Recruiting

Study contacts

  • Principal investigator: Sunil Solomon, MD — Johns Hopkins University
  • Study coordinator: Jennifer Hoffmann, CRNP
  • Email: jhoffm45@jh.edu
  • Phone: 410-955-1318

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.