Healthy Volunteer study: Tenofovir alafenamide [TAF]
Official title Evaluation of Single Dosing With Two F/TAF Tablets Among Healthy Volunteers
ClinicalTrials.gov ID: NCT07349758
What this study is testing
What is tenofovir alafenamide [TAF] 50 mg/emtricitabine [FTC] 400mg?
tenofovir alafenamide [TAF] 50 mg/emtricitabine [FTC] 400mg is an investigational medicine, taken by mouth, being studied as a potential treatment for healthy volunteer.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- ≥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
You likely can't join if
- 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...
- 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...
- Taking concomitant medications that that are known inducers/inhibitors of P-gp that would effect TAF absorption
See the full eligibility 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
- 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...
The study team makes the final eligibility decision.
Where it is enrolling
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Baltimore, Maryland, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.