HIV/AIDS Tuberculosis
Conditions
Interventions
BPaLMZ
Sponsors
David Boulware
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria: 1. First episode of definite or probable TBM with physician intention to treat 2. Age =18 years 3. Provision of Informed Consent 4. Living with HIV 5. Weight >35 kg, estimated or measured
Exclusion criteria
Exclusion criteria: 1. Additional active CNS infection 2. Known rifampicin-resistant TB 3. Allergy/contraindication to study medicine 4. More than 5 doses of any TB therapy received within the previous 14 days. 5. Presence of jaundice, known liver cirrhosis, elevated ALT or AST >3x upper limit normal, or total bilirubin >2x upper limit of normal* 6. Chronic Kidney Disease (stage 4) with estimated glomerular filtration rate 450ms* 8. Pregnancy* or breastfeeding 9. Cryptococcal antigen positivity in blood 10. Condition which makes participation in the trial not in their best interest. 11. Early Withdrawal Criteria*
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A hierarchical composite endpoint consists of time-to-death within 24 weeks, functional status at 24-weeks as assessed by a modified Rankin score (0-6 scale), and number of days of GCS = 15 within first 7 days of randomization. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Serious adverse events (SAE) ;Clinical Adverse Events by grade associated with TB drug discontinuation, dose reduction, or interruption >3 days.;Laboratory abnormalities grade 3-4;Neuropathy ;Drug induced liver injury (Grade >3 with ALT >5x upper limit or normal or total bilirubin >2.5x upper limit of normal) | — |
Countries
Uganda
Contacts
Public ContactMable Kabahubya
Clinical Trial Coordinator
Outcome results
None listed