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Could a One-Month TB pill be as good as three? new trial tests shorter prevention

NCT ID NCT05118490

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 1,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2023

Expected to finish

Dec 2025

An estimate. End dates often move.

Lead sponsor

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

13 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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

  • Fundação Aurum (The Aurum Institute Mozambique)

    Chokwé, Gaza Province, Mozambique

  • The Aurum Institute: Gavin J Churchyard Legacy Centre

    Klerksdorp, North West, 2571, South Africa

  • The Byramjee Jeejeebhoy Medical Centre (BJGMC-JHU) CRS

    Pune, Maharashtra, 411001, India

  • Yayasan KNCV - The Persahabatan Hospital, Jakarta

    Jakarta, Jaya, 14350, Indonesia

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Other studies related to the condition(s) this trial covers.