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Recruiting NCT07349758

Evaluation of Single Dosing With Two F/TAF Tablets Among Healthy Volunteers

Phase I Interventional Healthy Volunteer HIV Prevention

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: tenofovir alafenamide [TAF] 50 mg/emtricitabine [FTC] 400mg.
Who it may be relevant to
Registry conditions: Healthy Volunteer, HIV Prevention. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

Interventions

  • Drug tenofovir alafenamide [TAF] 50 mg/emtricitabine [FTC] 400mg
    One-time dose of two F/TAF tablets

Primary outcome measures

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

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • Johns Hopkins University School of Medicine — Baltimore

Identifiers

NCT: NCT07349758 · IRB00488588 · DP1DA060602

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗