NCT05118490Active, not recruitingPhase 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
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
Source: ClinicalTrials.gov · Last updated 12 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 1000 (estimated)
- First submitted
- 26 Oct 2021
- Start date
- 19 Jul 2023
- Primary completion date
- 11 Jul 2025
- Lead sponsor
- The Aurum Institute NPC
- Diseases
- Tuberculosis, HIV
- NCT number
- NCT05118490
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 1000
- From 19 Jul 2023 to the primary completion date, 11 Jul 2025
- 4 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
- Previous treatment for active or latent TB for more than 30 days within the past 2 years
- 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)
- Previous treatment for active or latent TB for \>30 days within the past 2 years
- On prohibited medications
Other illness
- Suspected acute hepatitis or known chronic or unstable liver disease\^
- On prohibited medications (see Appendix I)
- Group 2: HIV-negative household contacts of an adult with confirmed pulmonary TB in Mozambique and Indonesia
- Suspected acute hepatitis or known chronic or unstable liver disease\^
Lab values
- ALT \> 3 times the upper limit of normal (ULN)
- Total bilirubin \> 2.5 times the ULN
- ALT \> 3 times the upper limit of normal (ULN)
- Total bilirubin \> 2.5 times the ULN
Other
- Likely to move from the study area during the study period
- Known recent exposure to a TB case with resistance to isoniazid or rifampicin.
- On nevirapine, etravirine, rilpivirine, PI-based, or raltegravir-containing ART regimens
- Known sensitivity or intolerance to isoniazid or rifamycins
- Pregnancy or breastfeeding Females of childbearing potential who are unable or unwilling to use two forms of contraception\*\*
- Likely to move from the study area during the study period
- Known exposure to TB cases with resistance to isoniazid or rifampicin in the source case
- Known sensitivity or intolerance to isoniazid or rifamycins
- Pregnancy or breastfeeding Females of childbearing potential who are unable or unwilling to use two forms of contraception\*\*
Who the study is looking for
- Age ≥ 13 years
- Weight \> 30 kg
- HIV-seropositive
- HIV viral load \<400 copies/mL, defined as "virally suppressed," on an EFV or DTG-based ART regimen (see Section 3.6.2)
- Candidates must meet WHO criteria for receiving TPT
- Age ≥ 13 years
- Weight \> 30 kg
- HIV-negative
- Household contact of an adult with confirmed rifampicin-sensitive pulmonary TB
- Candidates must meet WHO criteria for receiving TPT
Criteria the registry did not label
- Group 1: HIV-positive adolescents and adults in South Africa and India
Age in the registry: 13 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Yayasan KNCV - The Persahabatan Hospital, Jakarta Coordinator of this site? Confirm its status | Jakarta | Indonesia | Unknown status |
| The Byramjee Jeejeebhoy Medical Centre (BJGMC-JHU) CRS Coordinator of this site? Confirm its status | Pune | India | Unknown status |
| Fundação Aurum (The Aurum Institute Mozambique) Coordinator of this site? Confirm its status | Chokwé | Mozambique | Unknown status |
| The Aurum Institute: Gavin J Churchyard Legacy Centre Coordinator of this site? Confirm its status | Klerksdorp | South Africa | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.