Comparing two treatment regimens for tuberculosis prevention in people living with HIV
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 "One To Three" Trial
This study is testing two different ways to prevent tuberculosis in people living with HIV and their family members to see which treatment works better.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 13 Years and up |
| Sex | All |
| Sponsor | The Aurum Institute NPC Academic / other |
| Locations | 4 sites (Pune, Maharashtra and 3 other locations) |
| Trial ID | NCT05118490 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a multicenter, randomized, open-label phase IV trial that compares two different regimens of tuberculosis preventive treatment in HIV-positive individuals and HIV-negative household contacts of tuberculosis patients. Participants will be stratified based on their HIV status and will receive either daily rifapentine and isoniazid for one month or weekly high-dose rifapentine and isoniazid for three months. The study will monitor participants for adherence, adverse events, and overall health through regular clinic visits and lab tests. The goal is to determine which regimen is more effective in completing treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are HIV-positive adolescents and adults aged 13 years and older who are on antiretroviral therapy and do not have active tuberculosis.
Not a fit: Patients with confirmed or suspected active tuberculosis or those with certain contraindications to the study medications will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective and convenient tuberculosis preventive treatment option for individuals living with HIV.
How similar studies have performed: Other studies have shown success with similar tuberculosis preventive treatment approaches, indicating potential for positive outcomes in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Pune, Maharashtra and 3 other locations
- The Byramjee Jeejeebhoy Medical Centre (BJGMC-JHU) CRS — Pune, Maharashtra, India (Recruiting)
- Yayasan KNCV - The Persahabatan Hospital, Jakarta — Jakarta, Jaya, Indonesia (Recruiting)
- Fundação Aurum (The Aurum Institute Mozambique) — Chokwé, Gaza, Mozambique (Recruiting)
- The Aurum Institute: Gavin J Churchyard Legacy Centre — Klerksdorp, North West Province, South Africa (Recruiting)
Study contacts
- Study coordinator: Jayajothi Moodley
- Email: JMoodley@auruminstitute.org
- Phone: +27826593766
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.