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NCT03510468 · ClinicalTrials.gov registry record · Phase 1
Impact of Weekly Administration of Rifapentine and Isoniazid on Steady State Pharmacokinetics of Tenofovir Alafenamide in Healthy Volunteers (YODA)
A Phase 1 study, sponsored by National Institutes of Health Clinical Center (CC).
- Completed
- Registry status
- Phase 1
- Development phase
- 51
- Enrollment target
NCT03510468: Completed Phase 1 study, sponsored by National Institutes of Health Clinical Center (CC).
NCT03510468 is a Phase 1 study that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 51 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03510468, a Phase 1 study, has completed, sponsored by National Institutes of Health Clinical Center (CC).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 51 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Plasma area under the curve (AUC) during the dosing interval of 0 to 24 hours (AUC0-24hr) on day 14, 22, and 31 of TAF was calculated using the linear-up/log-down trapezoidal rule using noncompartmental methods on Phoenix WinNonlin ®
Interventions
- DRUG Tenofovir alafenamide
- DRUG Isoniazid (INH)
- DIETARY_SUPPLEMENT Pyridoxine
- DRUG Rifapentine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2018-06-12 |
| Est. Completion | 2022-12-21 |
| Phase | Phase 1 |
What the finished NCT03510468 record still lists
NCT03510468 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% lower).
The record links to 0 conditions, and to 4 interventions - of which Tenofovir alafenamide is the first listed.
NCT03510468 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03510468 about?
NCT03510468 is a clinical study titled "Impact of Weekly Administration of Rifapentine and Isoniazid on Steady State Pharmacokinetics of Tenofovir Alafenamide in Healthy Volunteers (YODA)". 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 dr...
What is the current status of trial NCT03510468?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 51 participants. The study started on 2018-06-12. Estimated completion is 2022-12-21.
What interventions are being tested in trial NCT03510468?
The interventions under investigation include: Tenofovir alafenamide (DRUG), Isoniazid (INH) (DRUG), Pyridoxine (DIETARY_SUPPLEMENT), Rifapentine (DRUG).
Who is sponsoring clinical trial NCT03510468?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03510468's enrollment target sits among peer trials
51 969th of 2000 higher than 1,028 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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