NCT04951986Active, not recruitingPhase 3
Testing New Strategies for Patients Hospitalised With HIV-associated Disseminated Tuberculosis
Source: ClinicalTrials.gov · Last updated 6 Jan 2026
Brief summary (registry, in English)
The New Strat-TB trial is a superiority Phase III randomised control clinical trial with a 2X2 factorial design. The main aim of the study is to assess the efficacy and safety of high dose rifampicin and levofloxacin for 14 days in addition to standard TB therapy with or without steroids among adults hospitalized with HIV-associated disseminated tuberculosis. The investigators hypothesize that intensified treatment with increased rifampicin doses at 35 mg/kg plus levofloxacin will more rapidly reduce the mycobacterial load. The investigators also hypothesize that steroids will have an immune-modulatory effect and dampen the activation of the innate immune system. The investigators hypothesize that these two strategies will lead to improved survival in patients hospitalized with HIV-associated disseminated tuberculosis.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 732 (estimated)
- First submitted
- 30 Jun 2021
- Start date
- Aug 2021
- Primary completion date
- Dec 2025
- Lead sponsor
- University of Cape Town
- Diseases
- Tuberculosis, HIV
- NCT number
- NCT04951986
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 732
- From Aug 2021 to the primary completion date, Dec 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receiving corticosteroids or other immunosuppressive therapy
- Patients established on ART with Protease Inhibitor based regimen who cannot be switched to a dolutegravir based regimen
Other illness
- Active or recent SARS-CoV-2 infection
- Current malignancy requiring active treatment (including any Kaposi sarcoma lesions)
- Any condition in the opinion of the investigator for which participation would increase risk to the patient
Lab values
- ALT \>120 IU/L or total bilirubin \>34 μmol/L
Other
- Pregnant or breastfeeding
- TB treatment within the last 1 month or more than 2 doses of TB treatment
- Rifampicin resistance
- Neurological TB
- Plasma CrAg positive or cryptococcal meningitis
- Diabetic ketoacidosis or Hyperosmolar Non-ketotic acidosis
Who the study is looking for
- Aged \>18
- HIV infection
- Disseminated TB confirmed by one or more of the following tests being positive
- Lysed blood Xpert Ultra positive for MTB
- Concentrated urine Xpert Ultra positive for MTB
- Urine Alere LAM positive
- Hospital clinical team made decision to initiate TB treatment
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Khayelitsha Hospital, c/o Steve Biko and Walter Sisulu Drives, Khayelitsha Coordinator of this site? Confirm its status | Cape Town | South Africa | Unknown status |
| Mitchells Plain Hospital, Mitchells PLain Coordinator of this site? Confirm its status | Cape Town | South Africa | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.