A Phase 1/2 interventional study of Rifapentine and Isoniazid in Tuberculosis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Recruiting at 11 sites in 6 countries. Open to participants aged Up to 13 Years. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 1/2, Interventional, and Prevention
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.
1,170 studies on the registry are indexed under Tuberculosis; 175 are open to participants now.
This study's planned enrollment of 144 is close to the median of 150 across 820 interventional studies indexed under Tuberculosis.
Browse Tuberculosis studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.
Of its 405 completed or terminated interventional studies of FDA-regulated products, 302 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Age requirements at entry:
Weight requirements at entry:
status:
At risk of TB disease, defined as meeting at least one of the following:
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 taken the following medications:
The child has any of the following conditions:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will be enrolled by weight bands across five weight groups.
Drug: Rifapentine · Drug: Isoniazid
Participants will be enrolled by weight bands across five weight groups.
Drug: Rifapentine · Drug: Isoniazid · Drug: Dolutegravir
Dispersible Tablet administered orally
Also known as: RPT
Dispersible Tablet administered orally
Also known as: INH
Tablets and Tablets for oral suspension administered orally
Plasma concentration of Rifapentine (RPT) at specified time points among children with and without HIV
Time frame: Through Day 28
Area Under the Curve (AUC)(0-inf) of RPT
Time frame: Through Day 28
Maximum serum concentration (C(max)) of RPT
Time frame: Through Day 28
Half-life (t1/2) of RPT
Time frame: Through Day 28
Apparent oral clearance (CL/F) of RPT
Time frame: Through Day 28
Apparent oral volume of distribution (V/F) of RPT
Time frame: Through Day 28
Absorption rate (ka) of RPT
Time frame: Through Day 28
Trough serum concentration (C(trough)) of DTG (Cohort 2 only)
Time frame: At study entry, Day 28 and Day 42
CL/F of DTG (Cohort 2 only)
Time frame: At study entry, Day 28 and Day 42
Proportion of participants experiencing Adverse Events (AEs)
Time frame: Through Day 28
Proportion of participants experiencing Grade 3 or higher AEs
Time frame: Through Day 28
Proportion of participants experiencing Grade 2 or higher AEs assessed as related to 1HP
Time frame: Through Day 28
Proportion of participants experiencing Serious Adverse Events (SAEs) assessed as related to 1HP
Time frame: Through Day 28
Proportion of participants experiencing AEs assessed as related to 1HP that led to permanent discontinuation of the regimen
Time frame: Through Day 28
Relative effects of significant covariates on RPT PK
Significant covariates include age, weight, sex, ethnicity, nutritional status, and HIV-1 status
Time frame: Through Day 28
Proportion of participants experiencing AEs
Time frame: Through Day 168
Proportion of participants experiencing Grade 3 or higher AEs
Time frame: Through Day 168
Proportion of participants experiencing Grade 2 or higher AEs assessed as related to 1HP
Time frame: Through Day 168
Proportion of participants experiencing SAEs assessed as related to 1HP
Time frame: Through Day 168
Participant and/or parent/guardian reported palatability and acceptability of 1HP regimen
Time frame: 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
Time frame: 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.
Time frame: Through Day 28
Proportion of participants experiencing Grade 2 or higher AEs assessed as related to DTG (Cohort 2 only)
Time frame: Through Day 42
Proportion of participants experiencing SAEs assessed as related to DTG (Cohort 2 only)
Time frame: Through Day 42
Proportion of participants experiencing AEs assessed as related to DTG that led to permanent discontinuation of the regimen (Cohort 2 only)
Time frame: Through Day 42
Number of participants with HIV-1 RNA less than 200 copies/mL (Cohort 2 only)
Time frame: At Day 42
Plan to share: Yes — Individual participant data that underlie results in the publication, after deidentification.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning 3 months following publication and available throughout period of funding of the International Maternal Pediatric Adolescent AIDS Clinical Trial (IMPAACT) Network by NIH.
Access criteria: With whom? Researchers who provide a methodologically sound proposal for use of the data that is approved by the IMPAACT Network. For what types of analyses? To achieve aims in the proposal approved by the IMPAACT Network. By what mechanism will data be made available? Researchers may submit a request for access to data using the IMPAACT "Data Request" form at: https://www.impaactnetwork.org/resources/study-proposals.htm. Researchers of approved proposals will need to sign an IMPAACT Data Use Agreement before receiving the data
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drugs tested here: Rifapentine · Isoniazid
National Institute of Allergy and Infectious Diseases (NIAID) →