TuberculosisPhase 1/2NCT07124559
A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV
A Phase 1/2 study testing Rifapentine, Isoniazid and Dolutegravir in people with Tuberculosis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 11 sites in 6 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages Up to 13 years
- Conditions the study is for
- Tuberculosis
- What is being tested?
- Rifapentine, Isoniazid and Dolutegravir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 11 sitesin 6 countries
- Study dates
- 28 Sep 2026to 31 May 2028
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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:
- Cohort 1: Children under 13 years old.
- Cohort 2: Children aged 12 weeks to under 13 years old.
- 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:
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- Cohort 1: 3 kg to under 45 kg.
- Cohort 2: 6 kg to under 45 kg.
- HIV status:
- Cohort 1: Must be living without HIV.
- Cohort 2: Must be living with HIV.
- At risk of TB disease, defined as meeting at least one of the following:
- Having close contact with someone with infectious pulmonary TB within the past six months.
- A positive tuberculin skin test (TST) or, for those over two years old, a positive interferon gamma release assay (IGRA) if TST is not available.
- For Cohort 2 only: Living in a high TB burden area (≥ 60 TB cases per 100,000 people per year).
- Normal or mild (grade 1 or 2) test results for the following at screening (within 21 days before entry):
- ALT (liver enzyme)
- Estimated glomerular filtration rate (kidney function)
- Absolute neutrophil count (white blood cells)
- Hemoglobin (red blood cells)
- For Cohort 2 participants:
- Must have been on antiretroviral therapy (ART) for at least 12 weeks before entry.
- Must have been on a specific ART regimen (once-daily DTG and two NRTIs) for at least 14 days before entry.
- Must have used the same formulation of DTG (tablet or dispersible tablet) for at least three days before entry.
- Must agree to continue the same formulation of DTG for the study duration.
- Must have an HIV-1 RNA level below 200 copies/mL at screening.
- Must intend to stay in the same area for the study duration.
- Must have access to at least one meal per day during the 28-day treatment period.
Who cannot join
- The child has active TB, confirmed by medical records, parent/guardian report, or tests during screening, indicated by:
- Currently being treated for active TB.
- Symptoms like poor growth, poor weight gain, weight loss, cough for at least 11 days, or fever for at least eight days.
- X-ray or CT scan showing TB.
- Positive TB test results (e.g., culture, Xpert MTB/RIF Ultra, Truenat M.tb, other nucleic acid tests, urine tests).
- The child has been exposed to an adult with drug-resistant TB (resistant to Rifampicin or Isoniazid) within the past six months.
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- The child has taken the following medications:
- Daily Isoniazid in the 28 days before entry.
- Any prohibited medications listed in the study within three days before entry.
- The child has any of the following conditions:
- Acute or chronic hepatitis.
- Allergy to Isoniazid or rifamycins.
- Porphyria.
- Severe peripheral neuropathy.
- 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.
- The child has received long-term immunosuppressive therapy (more than eight days) within 30 days before entry. Note: Short courses of steroids (seven days or less) may be allowed with approval.
- The child is a result of a multiple birth (e.g., twins, triplets).
- The child has any other significant medical condition that would make participation unsafe, complicate data interpretation, or interfere with study objectives, as determined by the site investigator.
Trial locations and contacts
11 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
11 sites in 6 countries
Zimbabwe3 sites, 3 recruiting
- Not yet recruiting
St Mary's CRS (Site ID: 30303)
Chitungwiza
- Not yet recruiting
Harare Family Care CRS (Site ID: 31890)
Harare
- Not yet recruiting
Seke North CRS (Site ID: 30306)
Seke North, Chitungwiza
Botswana2 sites, 2 recruiting
- Recruiting
Gaborone (Site ID: 12701)
Gaborone
Gaerolwe Masheto, 267-3902671, gmasheto@bhp.org.bw
- Recruiting
Molepolole CRS (Site ID: 12702)
Molepolole
Gaerolwe Masheto, 267-3902671, gmasheto@bhp.org.bw
Thailand2 sites, 2 recruiting
- Not yet recruiting
Siriraj Hospital, Mahidol University NICHD CRS (Site ID: 5115)
Bangkok, Bangkoknoi, 10700
- Recruiting
Chiangrai Prachanukroh Hospital (Site ID: 5116)
Chiang Rai, 57000
Pra-ornsuda Sukrakanchana, 66-81-7468858, Pra-ornsuda.Sukrakanchana@phpt.org
Uganda2 sites, 2 recruiting
- Not yet recruiting
Baylor-Uganda CRS (Site ID: 31798)
Kampala
- Not yet recruiting
MU-JHU Research Collaboration (MUJHU CARE LTD) CRS (Site ID: 30293)
Kampala
Haiti1 site, 1 recruiting
- Not yet recruiting
Les Centres GHESKIO (Site ID: 30022)
Port-au-Prince, HT-6110
Kenya1 site, 1 recruiting
- Not yet recruiting
Kenya Medical Research Institute/Walter Reed Project Clinical Research Center, Kericho CRS (Site ID: 5121)
Kericho, 20200
About this study
Official title: Phase I/II Dose Finding, Safety and Tolerability Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV
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.
- Conditions
- Tuberculosis
- Being tested
- Rifapentine, Isoniazid, Dolutegravir
- Keywords
- HIV, Tuberculosis, Latent Tuberculosis
- Medical subject headings
- Tuberculosis, Latent Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RifapentineDrug
Also called RPT
Dispersible Tablet administered orally
IsoniazidDrug
Also called INH
Dispersible Tablet administered orally
DolutegravirDrug
Tablets and Tablets for oral suspension administered orally
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Children living without HIV | Experimental | Participants will be enrolled by weight bands across five weight groups. Receives: Drug: Rifapentine; Drug: Isoniazid |
| Cohort 2: Children living with HIV | Experimental | Participants will be enrolled by weight bands across five weight groups. Receives: Drug: Rifapentine; Drug: Isoniazid; Drug: Dolutegravir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration of Rifapentine (RPT) at specified time points among children with and without HIV
Measured: Through Day 28
Area Under the Curve (AUC)(0-inf) of RPT
Measured: Through Day 28
Maximum serum concentration (C(max)) of RPT
Measured: Through Day 28
Half-life (t1/2) of RPT
Measured: Through Day 28
Apparent oral clearance (CL/F) of RPT
Measured: Through Day 28
Apparent oral volume of distribution (V/F) of RPT
Measured: Through Day 28
Absorption rate (ka) of RPT
Measured: Through Day 28
Trough serum concentration (C(trough)) of DTG (Cohort 2 only)
Measured: At study entry, Day 28 and Day 42
CL/F of DTG (Cohort 2 only)
Measured: At study entry, Day 28 and Day 42
Proportion of participants experiencing Adverse Events (AEs)
Measured: Through Day 28
Proportion of participants experiencing Grade 3 or higher AEs
Measured: Through Day 28
Proportion of participants experiencing Grade 2 or higher AEs assessed as related to 1HP
Measured: Through Day 28
Proportion of participants experiencing Serious Adverse Events (SAEs) assessed as related to 1HP
Measured: Through Day 28
Proportion of participants experiencing AEs assessed as related to 1HP that led to permanent discontinuation of the regimen
Measured: Through Day 28
Secondary outcomes (12)
Relative effects of significant covariates on RPT PK
Significant covariates include age, weight, sex, ethnicity, nutritional status, and HIV-1 status
Measured: Through Day 28
Proportion of participants experiencing AEs
Measured: Through Day 168
Proportion of participants experiencing Grade 3 or higher AEs
Measured: Through Day 168
Proportion of participants experiencing Grade 2 or higher AEs assessed as related to 1HP
Measured: Through Day 168
Proportion of participants experiencing SAEs assessed as related to 1HP
Measured: Through Day 168
Participant and/or parent/guardian reported palatability and acceptability of 1HP regimen
Measured: At Day 1, Day 14, and Day 28
Number of occurrences of permanent discontinuation of 1HP regimen due to participant refusal to take 1HP or participant's parent/guardian decision to prematurely discontinue 1HP regimen
Measured: Through Day 168
Participant adherence to the 1HP regimen
Defined as having maintained at least 85% adherence to the 1HP regimen (24 doses) measured by observed and confirmed dosing and participant/parent/guardian report.
Measured: Through Day 28
Proportion of participants experiencing Grade 2 or higher AEs assessed as related to DTG (Cohort 2 only)
Measured: Through Day 42
Proportion of participants experiencing SAEs assessed as related to DTG (Cohort 2 only)
Measured: Through Day 42
Proportion of participants experiencing AEs assessed as related to DTG that led to permanent discontinuation of the regimen (Cohort 2 only)
Measured: Through Day 42
Number of participants with HIV-1 RNA less than 200 copies/mL (Cohort 2 only)
Measured: At Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start28 Sep 2026
- Primary completion31 Jan 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Cohort 1 will open to enrollment first and Cohort 2 will open following RPT dose confirmation in Cohort 1. Within each cohort, participants in all weight bands will be enrolled concurrently.
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07124559
- Sponsor's protocol ID
- IMPAACT 2024
- Other IDs
- 38747
- Status last verified
- Oct 2026
- First submitted
- 8 Aug 2025
- Last updated
- 19 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie results in the publication, after deidentification.