Testing New Strategies for Patients Hospitalised With HIV-associated Disseminated Tuberculosis

• Status: Not yet recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Cape Town
• Treatments: Ethambutol; Isoniazid; Levofloxacin; Ofloxacin; Prednisone; Pyrazinamide; Rifampin

Criteria

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