Could a One-Month TB pill be as good as three? new trial tests shorter prevention
NCT ID NCT05118490
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether taking two TB prevention drugs daily for one month works as well as taking them weekly for three months. It includes 1,000 people with HIV or those living with someone recently diagnosed with TB. The goal is to see which schedule more people complete and how safe and cost-effective each option is.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 1,000 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2023
- Expected to finish
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Dec 2025
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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13 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Fundação Aurum (The Aurum Institute Mozambique)
Chokwé, Gaza Province, Mozambique
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The Aurum Institute: Gavin J Churchyard Legacy Centre
Klerksdorp, North West, 2571, South Africa
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The Byramjee Jeejeebhoy Medical Centre (BJGMC-JHU) CRS
Pune, Maharashtra, 411001, India
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Yayasan KNCV - The Persahabatan Hospital, Jakarta
Jakarta, Jaya, 14350, Indonesia
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Once-Daily HIV pill with food match Twice-Daily dosing during TB treatment?
- Can simple sputum and urine tests catch tuberculosis earlier?
- Can a common virus be turned into a TB vaccine? scientists test VIR-1778
- Fish oil meets TB drugs: can Omega-3 help clear infection faster?
- Can starting TB treatment immediately save lives in HIV sepsis?
- Can a 4-Drug combo cut TB treatment time in half?