🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in India / NCT05118490
Active, not recruiting Phase 4

Comparing Treatment Completion Of Daily Rifapentine & Isoniazid For One Month (1HP) To Weekly High Dose Rifapentine & Isoniazid For 3 Months (3HP) In Persons Living With HIV and in Household Contacts of Recently Diagnosed Tuberculosis Patients

NCT05118490 · tracked via the Priya Life Science India tracker
Sponsor
The Aurum Institute NPC
Phase
Phase 4
Started
2023-07-19
Last updated
2025-12-12

Condition(s) studied

HIV SeropositivityTuberculosisHousehold Contact

Investigational drug(s) / intervention(s)

Daily rifapentine and isoniazid for 4 weeksWeekly rifapentine and isoniazid for 12 weeks

Daily rifapentine and isoniazid for 4 weeks: Arm A: isoniazid (300mg) and rifapentine (600mg) daily for 4 weeks (1HP)

Weekly rifapentine and isoniazid for 12 weeks: Arm B: isoniazid (900mg) and rifapentine (900mg) weekly for 12 weeks (3HP)

Study summary

A multicenter, randomized, stratified, open-label, phase IV trial among HIV-positive persons (PLHIV) on antiretroviral therapy (ART), or HIV-negative household contacts of patients with rifampicin-sensitive pulmonary tuberculosis (TB), who do not have evidence of active TB.

Eligibility

Sex
ALL
Min age
13 Years
Max age
Healthy volunteers
No
Group 1: HIV-positive adolescents and adults in South Africa and India Inclusion criteria: 1. Age ≥ 13 years 2. Weight \> 30 kg 3. HIV-seropositive 4. HIV viral load \<400 copies/mL, defined as "virally suppressed," on an EFV or DTG-based ART regimen (see Section 3.6.2) 5. Candidates must meet WHO criteria for receiving TPT Exclusion criteria: 1. Confirmed or suspected TB disease (evidenced by symptoms and/or clinical exam findings and/or chest radiographic findings suggestive of TB, positive mycobacterial culture or molecular TB testing or currently on TB treatment for active TB disease) 2. Likely to move from the study area during the study period 3. Known recent exposure to a TB case with resistance to isoniazid or rifampicin. 4. Previous treatment for active or latent TB for more than 30 days within the past 2 years 5. On nevirapine, etravirine, rilpivirine, PI-based, or raltegravir-containing ART regimens 6. Known sensitivity or intolerance to isoniazid or rifamycins 7. Suspected acute hepatitis or known chronic or unstable liver disease\^ 8. ALT \> 3 times the upper limit of normal (ULN) 9. Total bilirubin \> 2.5 times the ULN 10. Pregnancy or breastfeeding Females of childbearing potential who are unable or unwilling to use two forms of contraception\*\* 11. On prohibited medications (see Appendix I) Group 2: HIV-negative household contacts of an adult with confirmed pulmonary TB in Mozambique and Indonesia Inclusion criteria: 1. Age ≥ 13 years 2. Weight \> 30 kg 3. HIV-negative 4. Household contact of an adult with confirmed rifampicin-sensitive pulmonary TB 5. Candidates must meet WHO criteria for receiving TPT Exclusion criteria: 1. Confirmed or suspected TB disease (evidenced by symptoms and/or clinical exam findings and/or chest radiographic findings suggestive of TB, positive mycobacterial culture or molecular TB testing or currently on TB treatment for active TB disease) 2. Likely to move from the study area during the study period 3. Known exposure to TB cases with resistance to isoniazid or rifampicin in the source case 4. Previous treatment for active or latent TB for \>30 days within the past 2 years 5. Known sensitivity or intolerance to isoniazid or rifamycins 6. Suspected acute hepatitis or known chronic or unstable liver disease\^ 7. ALT \> 3 times the upper limit of normal (ULN) 8. Total bilirubin \> 2.5 times the ULN 9. Pregnancy or breastfeeding Females of childbearing potential who are unable or unwilling to use two forms of contraception\*\* 10. On prohibited medications

Primary outcome measure(s)

Trial sites (4)

FacilityCityRegionStatus
The Byramjee Jeejeebhoy Medical Centre (BJGMC-JHU) CRS Pune Maharashtra
Yayasan KNCV - The Persahabatan Hospital, Jakarta Jakarta Jaya
Fundação Aurum (The Aurum Institute Mozambique) Chokwé Gaza Province
The Aurum Institute: Gavin J Churchyard Legacy Centre Klerksdorp North West

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05118490 on ClinicalTrials.gov ↗ ← All trials in India