Health Trials

A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV

ConditionTuberculosis
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
AgeUp to 13
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

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.

Disqualifiers

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).

Trial design

Design model

Sequential

Treatments tested in this trial

  • Rifapentine

    Drug

    Dispersible Tablet administered orally

  • Isoniazid

    Drug

    Dispersible Tablet administered orally

  • Dolutegravir

    Drug

    Tablets and Tablets for oral suspension administered orally

Treatment groups

144 Participants
are divided into 2 treatment groups
Group A: Cohort 1: Children living without HIVExperimental treatment 2 interventions
Group B: Cohort 2: Children living with HIVExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Plasma concentration of Rifapentine (RPT) at specified time points among children with and without HIV

Time frame
Through Day 28
2

Area Under the Curve (AUC)(0-inf) of RPT

Time frame
Through Day 28
3

Maximum serum concentration (C(max)) of RPT

Time frame
Through Day 28
4

Half-life (t1/2) of RPT

Time frame
Through Day 28

Secondary outcomes

1

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
2

Proportion of participants experiencing AEs

Time frame
Through Day 168
3

Proportion of participants experiencing Grade 3 or higher AEs

Time frame
Through Day 168
4

Proportion of participants experiencing Grade 2 or higher AEs assessed as related to 1HP

Time frame
Through Day 168

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Institute of Allergy and Infectious Diseases (NIAID)

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

National Institute of Mental Health (NIMH)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: