Evaluation of Single Dosing With Two F/TAF Tablets Among Healthy Volunteers (DD-PrEP:)

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

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.

Study Overview

• Status: Recruiting
• Conditions: HIV Prevention; Healthy Volunteer
• Intervention / Treatment: Drug: tenofovir alafenamide [TAF] 50 mg/emtricitabine [FTC] 400mg

Detailed Description

HIV prevention using oral pre-exposure prophylaxis (PrEP) with tenofovir-containing regimens is a promising strategy to reduce the incidence of HIV infection. The study participants will receive a double dose [2 tablets] of Descovy (tenofovir alafenamide [TAF] 25 mg/emtricitabine [FTC] 200mg; F/TAF) and be followed over the course of 14 days. Intensive pharmacokinetic (PK) will occur right after dose administration, and become sparser over the next 14 days. Understanding the PK of TAF, tenofovir (TFV), and FTC and the intracellular metabolites could be used to assess the protective and therapeutic plausibility of alternate, less frequent dosing regimens for PrEP.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Jennifer Hoffmann, CRNP; Phone Number: 410-955-1318; Email: jhoffm45@jh.edu
• Study Contact Backup: Name: Pooja Akoijam, MD; Phone Number: 410-955-1201; Email: pakoija1@jh.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Recruiting
      • Johns Hopkins University School of Medicine
      • Contact: Jennifer Hoffmann, CRNP; Phone Number: 410-955-1318; Email: jhoffm45@jh.edu
      • Contact: Pooja Akoijam, MD; Phone Number: 410-955-1201; Email: pakoija1@jh.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: F/TAF dosing; Received one-time dosing of two F/TAF tablets	Drug: tenofovir alafenamide [TAF] 50 mg/emtricitabine [FTC] 400mg; One-time dose of two F/TAF tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Intracellular tenofovir-diphosphate concentrations (fmol/10^6)	168 hours

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Sunil Solomon, MD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: January 15, 2026
• First Submitted That Met QC Criteria: January 15, 2026
• First Posted (Actual): January 20, 2026

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: healthy volunteer; HIV PrEP
• Additional Relevant MeSH Terms: Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleic Acids, Nucleotides, and Nucleosides; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Nucleosides; Deoxyribonucleosides; Emtricitabine; tenofovir alafenamide; Racivir
• Other Study ID Numbers: IRB00488588; DP1DA060602 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No