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New study aims to safely prevent TB in pregnant women with HIV

NCT ID NCT05122026

Disease control Sponsor: The Aurum Institute NPC Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing two tuberculosis (TB) prevention treatments in pregnant women who also have HIV. The goal is to see if these treatments are safe and how they interact with the HIV medication dolutegravir. About 252 pregnant women will take either a daily TB drug for one month or a weekly dose for three months. The study will monitor for side effects and check drug levels in the blood.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
isoniazid and rifapentine
What this could lead to
If successful, this could provide a safe way to prevent tuberculosis in pregnant women with HIV without compromising their HIV treatment.
What could go wrong
This is an early-phase study with only 252 participants, so results may not apply to all pregnant women. There is a risk of side effects like liver problems or drug interactions.

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 252 people

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

Started

Jan 2024

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

18 years and older

Sex

Female participants only

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.

Inclusion Criteria: 1. Age \> 18 years 2. Weight \> 50 kg 3. Documented HIV infection 4. At least 4 weeks of ART and virally suppressed on dolutegravir plus two NRTIs 5. Undetectable HIV-1 viral load 6. Pregnancy at 20-34 weeks as confirmed by ultrasound 7. Singleton pregnancy Exclusion Criteria: 1. Confirmed or suspected TB disease 2. Likely to move from the study area during the study period 3. Known exposure to pulmonary TB cases with known or suspected resistance to isoniazid or rifampicin in the source case 4. TB treatment within the past year 5. TB preventive therapy within the last year 6. Sensitivity or intolerance to isoniazid or rifamycins 7. On nevirapine, etravirine, rilpivirine, PI-based, or raltegravir-containing ART regimens 8. Suspected acute hepatitis or known chronic liver disease; HBsAg positivity; severe hepatic impairment 9. Alanine aminotransferase (ALT) ≥ 3 times the upper limit of normal (ULN) 10. Total bilirubin ≥ 2.5 times the ULN 11. Absolute neutrophil count (ANC) \< 750 cells/mm3 12. Creatinine clearance \< 50 ml/min 13. Self-reported alcohol use exceeding 21 units per week 14. Karnofsky status \< 80 15. On prohibited medications e.g. dofetilide

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Conditions

The condition(s) this trial relates to.

HIV infectious disease HIV Seropositivity latent tuberculosis infection tuberculosis prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV seropositivity Pregnancy Tuberculosis infection

Contacts and locations

Locations

  • FAMily Centre for Research with Ubuntu (FAMCRU)

    Cape Town, Cape Town, 7505, South Africa

  • Peri Natal HIV Research Unit - Klerksdorp Tshepong Hospital

    Klerksdorp, North West, 2571, South Africa

  • The Aurum Institute: Tembisa Clinical Research Centre

    Tembisa, Gauteng, 1632, South Africa

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