Could a weekly pill prevent TB in kids with HIV?
NCT ID NCT05122767
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether a once-weekly combination of two drugs (rifapentine and isoniazid) can safely prevent tuberculosis in children and teens with HIV who are already taking the antiretroviral dolutegravir. About 92 participants aged 3 months to 17 years will receive the TB prevention for 12 weeks. Researchers will check for drug interactions and side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- rifapentine and isoniazid (3HP) plus dolutegravir
- What this could lead to
- If successful, this could provide a safe, short-course option to prevent tuberculosis in children with HIV who are on modern antiretroviral therapy.
- What could go wrong
- This is an early-phase (1/2) trial with only 92 participants, so results may not apply broadly. Drug interactions or side effects could still arise.
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 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
About 92 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
May 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
-
3 months to 17 years
- 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 Hide 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.
Inclusion criteria include: * Age 3 months through 17 years * Weight \> 3 kg * Documented HIV infection by DNA polymerase chain reaction (PCR) or plasma RNA-PCR if \<18 months and by HIV-ELISA if 18 months and confirmed with a DNA PCR or RNA-PCR from an independent sample * Undetectable HIV-1 viral load Exclusion criteria * 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) * Likely to move from the study area during the study period * Known exposure to TB cases with known or suspected resistance to isoniazid or rifampicin in the source case * TB treatment within the past year * Prior completion of a TPT course without re-exposure to persons with infectious TB since TPT completion * Receipt of once-daily INH for \>30 days that was given for at least 14 consecutive days in the 30 days prior to enrolment. * Sensitivity or intolerance to dolutegravir, isoniazid, or rifamycins * Suspected acute hepatitis or known chronic or unstable liver disease\^; HBsAg positivity or anti-hepatitis A virus (HAV) Immunoglobulin M (IgM) antibody; any infant born to a Hepatitis C positive mother in whom in utero infection in the infant is unknown or under evaluation * alanine aminotransferase (ALT) \> 3 times the upper limit of normal (ULN) * Total bilirubin \> 2 .5 times the ULN * Absolute neutrophil count (ANC) ≤ 750 cells/mm3 * Estimated creatinine clearance \< 60 ml/min (Bedside Schwartz formula)\* * Pregnancy or breastfeeding (infant of a breastfeeding mother is allowed) * Women of childbearing potential who are unable or unwilling to use two forms of contraception\*\* * Weight for age Z score below 2 or severe clinical malnutrition * On prohibited medications e.g. dofetilide (see Appendix 1) * Known porphyria
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for HIV are added.
Genom att skicka in godkänner du våra Användarvillkor
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
-
Peri Natal HIV Research Unit - Klerksdorp Tshepong Hospital
Klerksdorp, North West, 2571, South Africa
-
The Aurum Institute: Pretoria Clinical Research Centre
Pretoria, Gauteng, 0087, South Africa
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can 'Queen Mothers' bring HIV testing to the doorstep?
- Can a Once-Daily HIV pill with food match Twice-Daily dosing during TB treatment?
- Scientists map HIV's hiding spots in early infection
- Can simple sputum and urine tests catch tuberculosis earlier?
- Can a common virus be turned into a TB vaccine? scientists test VIR-1778
- Can local clinics keep more people with HIV in care?