Impact of Weekly Administration of Rifapentine and Isoniazid on Steady State Pharmacokinetics of Tenofovir Alafenamide in Healthy Volunteers (YODA)
Public ClinicalTrials.gov record NCT03510468. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
Impact of Weekly Administration of Rifapentine and Isoniazid on Steady State Pharmacokinetics of Tenofovir Alafenamide in Healthy Volunteers
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03510468
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 51 participants
Conditions and interventions
Conditions
Interventions
- Tenofovir alafenamide Drug
- Rifapentine Drug
- Isoniazid (INH) Drug
- Pyridoxine Dietary Supplement
Drug · Dietary Supplement
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 11, 2018
- Primary completion
- Nov 14, 2022
- Completion
- Dec 20, 2022
- Last update posted
- Aug 12, 2024
2018 – 2022
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03510468, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 12, 2024 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03510468 live on ClinicalTrials.gov.