Linezolid, Aspirin and Enhanced Dose Rifampicin in HIV-TBM
Status:
Completed
Trial end date:
2021-03-31
Target enrollment:
Participant gender:
Summary
LASER-TBM is a parallel group, randomized, multi-arm phase IIa trial evaluating the safety of
increased dose rifampicin (RIF) plus linezolid (LZD), with or without aspirin (ASA), for the
treatment of HIV-infected adults with tuberculous meningitis (TBM). The study will recruit
100 HIV-infected adults with TBM across four sites in South Africa.
The primary endpoint is the occurrence of solicited treatment-related adverse events.
Secondary endpoints include death and disability (including neurocognitive impairment),
radiological outcomes, and the occurrence of immune reconstitution inflammatory syndrome
(IRIS).
A nested pharmacokinetic (PK) substudy aims to:
1. Describe the plasma and cerebrospinal fluid (CSF) PK of LZD and high dose RIF.
2. Evaluate the relationship between drug exposures, toxicity and efficacy.
3. Compare exposures between intravenous and oral RIF administration.
4. Investigate the impact of high dose RIF on LZD and dolutegravir (DTG).