Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-29 @ 1:55 PM
Study NCT ID:
NCT03510468
Status:
COMPLETED
Last Update Posted:
2024-08-13
First Post:
2018-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Impact of Weekly Administration of Rifapentine and Isoniazid on Steady State Pharmacokinetics of Tenofovir Alafenamide in Healthy Volunteers (YODA)
Sponsor:
National Institutes of Health Clinical Center (CC)
Organization:
Study Overview
Official Title:
Impact of Weekly Administration of Rifapentine and Isoniazid on Steady State Pharmacokinetics of Tenofovir Alafenamide in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2022-12-21
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
Rifapentine (RPT) is a long-acting rifamycin that can be used weekly with isoniazid (INH) as a first-line regimen in the treatment of latent tuberculosis infection (LTBI). Although this regimen offers several potential benefits, the use of weekly RPT plus INH is limited in adults infected with human immunodeficiency virus (HIV) on antiretroviral therapy (ART) due to lack of drug interaction data with antiretrovirals (ARVs). Tenofovir alafenamide (TAF) is a preferred backbone agent by the current Department of Health and Human Services ARV guidelines and is a part of multiple recommended first-line regimens for the treatment of HIV. However, the use of TAF with rifamycins, including RPT, is not recommended due to potential drug interactions. Thus, the purpose of this study is to determine the effects of concomitant RPT and INH administration on the steady state pharmacokinetics (PK) of plasma TAF, plasma tenofovir (TFV), and intracellular TFV diphosphate (dp).
This is an open-label, fixed sequence, intrasubject drug-drug interaction study designed to evaluate the steady state PK of TAF, TFV, and TFV-dp with coadministration of once-weekly RPT + INH administered at doses used to treat LTBI. The study will consist of two phases: (1) TAF once daily alone (days 1-14) and (2) TAF once daily + weight-based RPT + INH once weekly (days 15-31). Participants will undergo periodic serial ARV PK blood draws over 24 hours on days 14-15, 22-23, and 31-32.
TAF, TFV, and TFV-dp PK will be determined using non-compartmental methods. The following PK parameters will be compared between phases: area under the curve over the dosing interval, maximum plasma concentration, time to maximum plasma concentration, terminal half-life, apparent oral clearance, and minimum plasma concentration. Adverse events will be graded and recorded.
This is an open-label, fixed sequence, intrasubject drug-drug interaction study designed to evaluate the steady state PK of TAF, TFV, and TFV-dp with coadministration of once-weekly RPT + INH administered at doses used to treat LTBI. The study will consist of two phases: (1) TAF once daily alone (days 1-14) and (2) TAF once daily + weight-based RPT + INH once weekly (days 15-31). Participants will undergo periodic serial ARV PK blood draws over 24 hours on days 14-15, 22-23, and 31-32.
TAF, TFV, and TFV-dp PK will be determined using non-compartmental methods. The following PK parameters will be compared between phases: area under the curve over the dosing interval, maximum plasma concentration, time to maximum plasma concentration, terminal half-life, apparent oral clearance, and minimum plasma concentration. Adverse events will be graded and recorded.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 18-CC-0087 | None | None | View |