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Can starting TB treatment immediately save lives in HIV sepsis?

NCT ID NCT04618198

Disease control Sponsor: University of Virginia Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 09, 2026 · Last updated Sep 10, 2026 · Updated 1 time

Summary

In sub-Saharan Africa, tuberculosis often causes sepsis in people living with HIV, and many die within days. This phase 3 trial tests two changes to standard care: starting anti-TB therapy right away instead of waiting for test results, and using a higher, sepsis-specific dose instead of the standard weight-based dose. The study enrolls 437 adults with HIV admitted to hospitals in Uganda and Tanzania with signs of infection and sepsis. Researchers compare 28-day survival between the different treatment approaches.

What this could mean

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

Active substance
anti-tuberculosis therapy, given immediately at a higher sepsis-specific dose
What this could lead to
If it works, this could give doctors in sub-Saharan Africa a clear reason to start TB treatment immediately in HIV patients with sepsis, before lab tests confirm TB, and to use higher doses. That could save lives in a condition where many patients die within days.
What could go wrong
The trial may show that immediate or higher-dose TB therapy does not improve survival, or that side effects outweigh benefits. Sepsis patients are very sick, and adding strong antibiotics early could cause liver or kidney problems. Results from Uganda and Tanzania may not apply everywhere.

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

437 people

The number who actually took part.

Started

Jan 2022

Finished

May 2025

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: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female aged ≥18 years living with HIV 4. Admitted to hospital with 1) clinical concern for infection; 2) ≥2 qSOFA score criteria (Glasgow Coma Scale score \<15, a respiratory rate ≥22, or a systolic blood pressure ≤90 mmHg or a mean arterial pressure of ≤65 mmHg) 5. Resident within a pre-defined geographic area to ensure TB clinic follow-up 6. For females of reproductive potential: use of highly effective contraception through 28 days Exclusion Criteria: 1. Known active TB or receiving anti-TB therapy 2. Pregnancy or lactation. Women will undergo urine pregnancy screening. Pregnant women will be excluded due to the possible toxicity and teratogenicity of high dose rifampin and isoniazid included in anti-TB therapy as well as possible teratogenicity of dolutegravir which is recommended as first-line antiretroviral therapy in this study. 3. Known allergic reactions to the components of the anti-TB therapy 4. Treatment with another investigational drug or other intervention within one month 5. Known liver disease 6. Alcohol use \> 14 standardized drinks per week and/or \> 4 drinks per day for men and \>7 standardized drinks per week and/or \>3 drinks per day for women, defined as 14 grams of ethanol, as found in example 5 ounces of wine, 12 ounces of beer, or 1.5 ounces of 80 proof spirits 7. Positive serum cryptococcal antigen test 8. Current treatment with a drug known to have significant interaction with anti-TB therapy

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Conditions

The condition(s) this trial relates to.

HIV infectious disease infectious disease with sepsis Sepsis tuberculosis

As listed by the trial registrant

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

HIV I infection Sepsis Tuberculosis

Contacts and locations

Locations

  • Kibong'oto Infectious Diseases Hospital

    Sanya Juu, Tanzania

  • Mbarara University Science Technology

    Mbarara, Uganda

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