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 range13 Years
SexALL
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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:
✓. 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:
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)
Timeframe: At study entry, Day 28 and Day 42
9
Trial details
NCT IDNCT07124559
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
✕. 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.
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