NIH-funded research U01 cooperative agreement

Steroids and better antibiotics for sepsis in people with AIDS in Africa

Official title: STeroids and enhanced Antibiotics for the treatment of patients in Africa with Refractory Sepsis: STARS trial

Funded at University of Virginia · NIH-11617035 · Data updated 2026-11-12

This study tests whether adding hydrocortisone and stronger antibiotics can improve survival for adults with sepsis who also have AIDS or advanced immune suppression in regions with high TB.

Quick facts

Grant typeU01 cooperative agreement
Study typeNIH-funded research
Funding institutionUniversity of Virginia
NIH-funded
Lab location1 site (Charlottesville, United States)
Project startSeptember 20, 2025
Project endAugust 31, 2030
Funding year2026
Award (this year)$162,000
NIH project number3U01AI192033-02S1
Project IDNIH-11617035 on NIH RePORTER

Who could benefit from this research

Could help

Adults with HIV/AIDS and sepsis, treated at study sites in TB-endemic regions, who consent to participate.

Less likely to help

Patients without sepsis or without HIV/AIDS or not meeting the trial criteria may not benefit from this specific intervention.

What this research studies

If you or a loved one has AIDS and develops sepsis, this trial explores a treatment strategy that combines a 7-day hydrocortisone course with a 7-day taper along with enhanced antibiotic therapy. The goal is to reduce death within 28 days by addressing both the inflammatory response and drug-resistant infections that are common in TB-endemic areas. Participants would be adults enrolled at study sites, with careful monitoring for responses and potential side effects. The study builds on observational findings suggesting corticosteroids may help septic shock patients in this population, aiming to provide clearer, actionable guidance.

Why it matters

Potential benefit: If successful, the approach could improve survival for people with AIDS who develop sepsis when treated with a corticosteroid-supported antibiotic regimen.

How similar studies have gone: Preliminary observational data suggest potential survival benefits from corticosteroids in similar settings, but results are not yet definitive.

Where this research is happening

  • University of Virginia
    Charlottesville, United States
    Active

Researchers

  • Principal investigator: Heysell, Scott K — University of Virginia
  • Study coordinator: Heysell, Scott K

Related research

Other NIH-funded projects on the same topics.

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.