‘LASER-TBM’ Linezolid, ASpirin and Enhanced dose Rifampicin in HIV-TBM

Authors
Category Primary study
Registry of TrialsPan African Clinical Trials Registry
Year 2018
INTERVENTION: Arm 1 Standard Antitubercular Therapy Arm 2 Intensified Antitubercular Therapy and LZD Arm 3 Intensified Antitubercular Therapy and LZD and ASA CONDITION: ; HIV/AIDS ; Tuberculous meningitis HIV/AIDS Tuberculous meningitis PRIMARY OUTCOME: The incidence of solicited treatment‐related AEs and death at 56 days associated with increased dose RIF plus LZD with or without adjunctive ASA, when administered alongside standard antitubercular SECONDARY OUTCOME: 1. Death (MRS 6) and disability (MRS 5) ; ; ; ; 10. MRI and CT changes 2. Death ; 3. Disability, stratified by baseline MRC grade. ; 4. Grade 3 or 4 AE. ; 5. Permanent discontinuation of experimental drugs. ; 6. Severity and frequency of haematologic and neurologic AE and hyperlactataemia related to LZD use. ; 7. Severity and frequency of major bleeding (gastrointestinal and intracerebral) related to ASA use. ; 8. M. tb culture status and time to positivity in automated liquid culture (MGIT) and Gene Xpert® Ultra cycle threshold (Ct) values ; 9. The occurrence of TBM‐IRIS assessed by the modified INSHI criteria [17]. ; INCLUSION CRITERIA: HIV‐1 seropositivity by rapid test, confirmed by enzyme‐linked immunosorbent assay (regardless of ART status); Age 18 years or older; Tuberculous Meningitis defined as ‘possible’, ‘probable’ or ‘definite’ as per the published case definition[68]
Epistemonikos ID: d32e1a11607c50c8a2b3c79e2f039c0283f79e28
First added on: Aug 24, 2024