This study aims to find the proposed dose of Rifapentine (RPT) taken once daily with Isoniazid (INH) for 28 days to prevent tuberculosis (TB). The study will take place at multiple locations and children under 13 years old will be divided into two groups: one group will include children without HIV, and the other group will include children with HIV who are on antiretroviral treatment. Up to 144 children will participate, and participants in each group will be followed for 24 weeks.
Who can participate
Age range
13 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. A parent or legal guardian must be willing and able to give written permission for the child to participate in the study. If required by local policies, the child must also be willing and able to give written assent to participate. All sites must follow local policies and procedures.
. Age requirements at entry:
. For Cohort 1 participants under 28 days old: The child must have been born at or after 37 weeks of pregnancy, as determined by the site investigator using parent/guardian report or medical records.
. Weight requirements at entry:
. HIV status:
. At risk of TB disease, defined as meeting at least one of the following:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Plasma concentration of Rifapentine (RPT) at specified time points among children with and without HIV
Timeframe: Through Day 28
2
Area Under the Curve (AUC)(0-inf) of RPT
Timeframe: Through Day 28
3
Maximum serum concentration (C(max)) of RPT
Timeframe: Through Day 28
4
Half-life (t1/2) of RPT
Timeframe: Through Day 28
5
Apparent oral clearance (CL/F) of RPT
Timeframe: Through Day 28
6
Apparent oral volume of distribution (V/F) of RPT
Timeframe: Through Day 28
7
Absorption rate (ka) of RPT
Timeframe: Through Day 28
8
Trough serum concentration (C(trough)) of DTG (Cohort 2 only)
Trial details
NCT IDNCT07124559
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
. Normal or mild (grade 1 or 2) test results for the following at screening (within 21 days before entry):
. For Cohort 2 participants:
Exclusion criteria
. The child has active TB, confirmed by medical records, parent/guardian report, or tests during screening, indicated by:
. The child has been exposed to an adult with drug-resistant TB (resistant to Rifampicin or Isoniazid) within the past six months.
. The child has taken the following medications:
. The child has any of the following conditions:
. The child has severe acute malnutrition (weight-for-height/length less than -3 z-scores of WHO standards). Note: Children who are stunted (height-for-age more than two standard deviations below WHO standards) are eligible.
. For Cohort 2: The child has an active AIDS-defining opportunistic infection.
. The child has started menstruation.
. The child has taken NVP, EFV, lopinavir/ritonavir, and/or raltegravir within 14 days before entry.
Timeframe: At study entry, Day 28 and Day 42
9
CL/F of DTG (Cohort 2 only)
Timeframe: At study entry, Day 28 and Day 42
10
Proportion of participants experiencing Adverse Events (AEs)
Timeframe: Through Day 28
11
Proportion of participants experiencing Grade 3 or higher AEs
Timeframe: Through Day 28
12
Proportion of participants experiencing Grade 2 or higher AEs assessed as related to 1HP
Timeframe: Through Day 28
13
Proportion of participants experiencing Serious Adverse Events (SAEs) assessed as related to 1HP
Timeframe: Through Day 28
14
Proportion of participants experiencing AEs assessed as related to 1HP that led to permanent discontinuation of the regimen