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New combo treatment aims to slash sepsis deaths in HIV patients

NCT ID NCT07332325

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether adding a steroid (hydrocortisone) and a stronger mix of antibiotics to standard care can improve survival in HIV patients with sepsis in sub-Saharan Africa. The study will enroll 344 adults and measure how many are alive after 28 days. It aims to address the high death rate from sepsis in this region, often driven by tuberculosis and drug-resistant bacteria.

What this could mean

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

Active substance
Hydrocortisone and a combination of antibiotics (rifampin, isoniazid, linezolid, levofloxacin)
What this could lead to
If successful, this could establish a new standard treatment for sepsis in HIV-endemic regions, potentially saving many lives.
What could go wrong
This is a single trial in a specific region and population. Results may not apply elsewhere, and the added drugs carry risks like side effects 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 3

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

Participants

About 344 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Sep 2029

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: 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 people will be excluded due to lack of pharmacokinetic data for the expanded antibiotic regimen in pregnancy. 3. Known allergic reactions to the components of the interventional 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, non-correctable interaction with anti-TB therapy 9. Already receiving corticosteroids at the time of presentation to the hospital

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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.

Sepsis Tuberculosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Fort Portal Regional Referral Hospital

    Fort Portal, Uganda

  • Kibong'oto Infectious Diseases Hospital

    Sanya Juu, Tanzania

  • Mbarara Regional Referral Hospital

    Mbarara, Uganda

  • Sekou Toure Regional Referral Hospital

    Mwanza, Tanzania

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