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Clinical trialNCT03510468CompletedPhase 1Interventional

Impact of Weekly Administration of Rifapentine and Isoniazid on Steady State Pharmacokinetics of Tenofovir Alafenamide in Healthy Volunteers (YODA)

SponsorNational Institutes of Health Clinical Center (CC)Enrollment51Healthy Volunteers
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

Background: Human immunodeficiency virus (HIV) is treated with antiretroviral drugs. Many people with HIV also have the lung infection tuberculosis (TB). Most TB treatments are complicated. A simpler treatment of two TB drugs can be taken once a week. Researchers want to study how the HIV and TB drugs affect each other so people who take both can be treated safely. Objective: To study if rifapentine and isoniazid affect blood levels of the common antiretroviral TAF. Eligibility: Healthy adults ages 18-65 without HIV, TB, or hepatitis Design: Participants will fast before the screening visit. They will have a medical history, physical exam, and blood tests. Women may have a pregnancy test. During the study, participants must: Use effective birth control Not take most medicine Not drink alcohol At the baseline visit, participants will repeat screening tests and get TAF tablets. Participants will take TAF once a day for 31 days. They will keep track of doses and side effects. Over 32 days, participants will have 4 long visits and 4 short. At all visits, participants will: Fast the night before Get food Take that day's TAF Review their TAF supply Have pregnancy and blood tests Report side effects At 3 visits, participants will also take the 2 TB drugs and vitamin B6. At 3 long visits, participants will also have blood collected 8 times over 8 hours by plastic tube in an arm vein. Around Day 46, participants will fast and have blood and pregnancy tests. Two weeks later, they will get a call to see how they are feeling.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

  • Joseph A Kovacs, M.D.

    National Institutes of Health Clinical Center (CC)

    Principal Investigator

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • National Institutes of Health Clinical Center

    Bethesda, Maryland, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
12 Jun 2018
Primary completion
15 Nov 2022
Completion
21 Dec 2022
Last update posted
13 Aug 2024
Registered enrollment
51
Registry id
NCT03510468

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.