Tuberculosis
Conditions
Interventions
Rifapentine
Sponsors
National Institute of Allergy and Infectious Diseases
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age: Cohort 1: Less than 13 years Cohort 2: 12 weeks to less than 13 years For Cohort 1 participants less than 28 days of age: At entry, gestational age at birth greater than or equal to 37 weeks Weight at entry: Cohort 1: 3 kg to less than 45 kg, Cohort 2: 6 kg to less than 45 kg HIV status determined At risk of TB disease Has normal, grade 1, or grade 2 test results for all of the following at screening: ALT, Estimated glomerular filtration rate (eGFR), Absolute neutrophil count, Hemoglobin For Cohort 2 potential participants: Has taken ART for at least 12 consecutive weeks immediately prior to entry Took the same formulation of DTG (tablet or dispersible tablet) for at least three days immediately prior to entry At entry, participant agrees to take the same formulation of DTG for the duration of the twice-daily DTG regimen. Has an HIV-1 RNA result less than 200 copies/mL at screening (i.e., from a specimen collected within 21 days prior to entry).
Exclusion criteria
Exclusion criteria: Active TB (bacteriologically confirmed or clinically diagnosed) Exposure to an adult with known infectious RIF-resistant or INH-resistant TB within six months prior to entry based Receipt of INH or prohibited medications Has any of the following:Clinical evidence of acute or chronic hepatitis, Known allergy or hypersensitivity to INH or rifamycins, Known porphyria, Known peripheral neuropathy (grade 2 or higher). Severe acute malnutrition, Active AIDS-defining opportunistic infection (WHO Clinical Stage 4) for Cohort 2 participants
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety-The primary safety analyses will focus on the 28-day time period during which 1HP is administered for Cohorts 1 and 2 participants. The primary safety analysis population is defined as participants who were exposed to at least one dose of the confirmed dosing regimen (see Section 3.1). Occurrence of any of the following (during the 28-day time period since 1HP is initiated) may be considered an intercurrent event, depending on reason for the event and also the primary safety outcome measure being analyzed: (1) permanent discontinuation of 1HP (2) death (3) or receipt of incorrect dosing regimen.The proportions of participants experiencing outcome measures including All AEs through Day 28, Grade 3 or higher AEs occurring through Day 28, Grade 2 or higher AEs assessed as related to 1HP through Day 28 and SAEs assessed as related to 1HP through Day 28 AEs assessed as related to 1HP that led to permanent discontinuation of the regimen* through Day 28 will be presented in aggregate with both cohorts combined, by cohort (by HIV status), by weight group (across both cohorts), and broken down by weight group within each cohort, with these proportions bounded by 95% CIs using Wilson’s score method. | — |
Secondary
| Measure | Time frame |
|---|---|
| All AEs through Day 168 Grade 3 or higher AEs occurring through Day 168 Grade 2 or higher AEs assessed as related to 1HP through Day 168 SAEs assessed as related to 1HP through Day 168 | — |
Countries
Kenya
Contacts
Public ContactCHARLES KILEL
Kenya Medical Research Institute Walter Reed Project Clinical Research Center
Outcome results
None listed