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

Johns Hopkins University

Status and phase

Enrolling

Phase 1

Conditions

HIV Prevention

Healthy Volunteer

Treatments

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

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT07349758

DP1DA060602 (U.S. NIH Grant/Contract)

IRB00488588

Details and patient eligibility

About

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.

Full 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.

Enrollment

24 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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