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Can higher doses and steroids beat TB in HIV patients?

NCT ID NCT04738812

Disease control Sponsor: ANRS, Emerging Infectious Diseases 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether a stronger tuberculosis (TB) treatment could save more lives in people with HIV and very weak immune systems. Over 1,300 hospitalized patients received either the standard TB drugs or an intensified version with higher doses of two key medicines, plus a steroid and a deworming pill. The goal was to see if the stronger regimen reduced deaths over 48 weeks.

What this could mean

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

Active substance
higher doses of rifampicin and isoniazid, plus prednisone and albendazole
What this could lead to
If successful, this could lead to a more effective TB treatment for people with advanced HIV, potentially reducing deaths.
What could go wrong
The trial is completed but results are not yet widely confirmed. Higher drug doses may increase side effects, and the approach may not work for all patients.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

1,330 people

The number who actually took part.

Started

Apr 2022

Finished

Nov 2025

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

15 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.

INCLUSION CRITERIA * Patient (and legally designed representative of minor patient) able to correctly understand the trial and to sign the informed consent * Aged ≥ 15 years * Confirmed HIV-1 infection as documented at any time prior to trial entry per national HIV testing procedures * CD4 count ≤ 100 cells/μL * Hospitalized for a newly diagnosed TB, defined by: * Any positive Xpert® MTB/RIF specimen (sputum, urine, pus, other), * Or a positive urine lipoarabinomannan (LAM) test, * Or an abnormal chest X-ray compatible with active TB EXCLUSION CRITERA * Initiation of TB drugs for more than 7 days * History of TB treatment during the last 6 months * Central neurological symptoms, including but not restrictive to TB meningitis * Suspected TB pericarditis * Documented Mycobacterium tuberculosis strain resistant to rifampicin using rapid molecular testing (Xpert® MTB/RIF) * Any concomitant medication or known hypersensitivity contraindicating any component of the TB treatment * HIV-2 co-infection * Current treatment with ART containing protease inhibitors * Any contraindication to efavirenz and dolutegravir * Severe associated diseases requiring corticosteroids or for which corticosteroids are contra-indicated * Impaired hepatic function with ALT (SGPT) \> 5 times the upper limit of normal (ULN) value * Creatinine clearance \< 30 mL/min/1.73m2 (according to either the MDRD or the CKD-EPI formula) * Pregnancy or breastfeeding

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Conditions

The condition(s) this trial relates to.

HIV infectious disease immunodeficiency disease tuberculosis

As listed by the trial registrant

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

HIV-1-infection Immuno-deficiency Tuberculosis

Contacts and locations

Locations

  • Ignace Deen Hospital

    Conakry, Guinea

  • Jamot Hospital

    Yaoundé, Cameroon

  • MACHAVA Hospital

    Maputo, Mozambique

  • Mbarara Regional Referral hospital

    Mbarara, Uganda

  • National Center for HIV/AIDS, Dermatology and STD (NCHADS)

    Phnom Penh, Cambodia

  • University Teaching Hospital

    Lusaka, Zambia

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