Short-and ultra-short course treatment with medicines, Isoniazid and Rifapentine for the prevention of TB disease

A Randomized Trial Comparing Treatment Completion of Daily Rifapentine & Isoniazid For One Month (1HP) To Weekly Rifapentine & Isoniazid For 3 Months (3HP) In Persons Living With HIV and in HIV-negative Household Contacts of Recently Diagnosed Tuberculosis Patients, The â??One To Threeâ?? Trial - ONE TO THREE TRIAL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/12/048627

Enrollment

1000

Registered

2022-12-30

Start date

Unknown

Completion date

Unknown

Last updated

2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: B20- Human immunodeficiency virus [HIV]disease

Interventions

Intervention1: Isoniazid and Rifapentine: Arm A: isoniazid (300mg) and rifapentine (600mg) daily for 4 weeks (1HP) Daily rifapentine and isoniazid for 4 weeks 250 participants age â?¥13 years of age w

Eligibility

Inclusion criteria

Inclusion criteria: Age >= 13 years Weight > 30 kg HIV-seropositive HIV viral load Candidates must meet national criteria for receiving TPT

Exclusion criteria

Exclusion criteria: Confirmed or suspected TB disease Likely to move from the study area during the study period Known recent exposure to a TB case with resistance to isoniazid or rifampicin Previous treatment for active or latent TB for more than 30 days within the past 2 years On nevirapine, etravirine, rilpivirine, PI-based, or raltegravir-containing ART regimens Known sensitivity or intolerance to isoniazid or rifamycins Suspected acute hepatitis or known chronic or unstable liver disease Alanine aminotransferase (ALT) > 3 times the upper limit of normal Total bilirubin > 2.5 times the ULN Pregnancy or breastfeeding Females of childbearing potential who are unable or unwilling to use two forms of contraception On prohibited medications

Design outcomes

Primary

Measure	Time frame
1 Successful completion of TPT with 90% adherence documented by self-report, pill count, and EMD reporting 2 Safety of treatment regimens, defined as occurrence of Grade 2 or higher targeted safety events and discontinuation of study medications because of side effects Targeted safety events are hypersensitivity syndrome, rash, seizure, peripheral neuropathy, hepatotoxicity, nausea and vomiting, and drug-related fever Timepoint: from study entry at Week 0 through up to 8 weeks of 1HP (Group 1) or up to 24 weeks of 3HP (Group 2)	—

Measure

Time frame

1 Successful completion of TPT with 90% adherence documented by self-report, pill count, and EMD reporting 2 Safety of treatment regimens, defined as occurrence of Grade 2 or higher targeted safety events and discontinuation of study medications because of side effects Targeted safety events are hypersensitivity syndrome, rash, seizure, peripheral neuropathy, hepatotoxicity, nausea and vomiting, and drug-related fever Timepoint: from study entry at Week 0 through up to 8 weeks of 1HP (Group 1) or up to 24 weeks of 3HP (Group 2)

—

Secondary

Measure	Time frame
Incremental cost-effectiveness of 1HP and 3HP (compared to each other, 6H, and no treatment) using a societal perspectiveTimepoint: from study entry at Week 0 through up to 8 weeks of 1HP (Group 1) or up to 24 weeks of 3HP (Group 2)	—

Countries

India, Indonesia, Mozambique, South Africa

Contacts

Public ContactDr Nishi Suryavanshi

BJMC CTU

vidyamave@gmail.com9503646148

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026