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New combo therapy aims to cut deaths in HIV patients with widespread TB

NCT ID NCT04951986

Disease control Sponsor: University of Cape Town 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether giving higher doses of a TB drug (rifampicin) plus an extra antibiotic (levofloxacin) for 14 days, with or without steroids, can help more people survive. It includes 732 adults with HIV who are hospitalized for TB that has spread beyond the lungs. The goal is to find a better way to control the disease and reduce deaths.

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

About 732 people

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

Started

Aug 2021

Expected to finish

Mar 2026

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

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: * Aged \>18 * HIV infection * Disseminated TB confirmed by one or more of the following tests being positive 1. Lysed blood Xpert Ultra positive for MTB 2. Concentrated urine Xpert Ultra positive for MTB 3. Urine Alere LAM positive * Hospital clinical team made decision to initiate TB treatment Exclusion Criteria: * Pregnant or breastfeeding * Active or recent SARS-CoV-2 infection * TB treatment within the last 1 month or more than 2 doses of TB treatment * Rifampicin resistance * Neurological TB * Receiving corticosteroids or other immunosuppressive therapy * ALT \>120 IU/L or total bilirubin \>34 μmol/L * Plasma CrAg positive or cryptococcal meningitis * Current malignancy requiring active treatment (including any Kaposi sarcoma lesions) * Patients established on ART with Protease Inhibitor based regimen who cannot be switched to a dolutegravir based regimen * Diabetic ketoacidosis or Hyperosmolar Non-ketotic acidosis * Any condition in the opinion of the investigator for which participation would increase risk to the patient

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Conditions

The condition(s) this trial relates to.

HIV infectious disease miliary tuberculosis

As listed by the trial registrant

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

Disseminated tuberculosis HIV

Contacts and locations

Locations

  • Khayelitsha Hospital, c/o Steve Biko and Walter Sisulu Drives, Khayelitsha

    Cape Town, Western Cape, 7784, South Africa

  • Mitchells Plain Hospital, Mitchells PLain

    Cape Town, Western Cape, 7785, South Africa

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