Linezolid, Aspirin and Enhanced Dose Rifampicin in HIV-TBM (NCT03927313) | Clinical Trial Compass
CompletedPhase 2
Linezolid, Aspirin and Enhanced Dose Rifampicin in HIV-TBM
South Africa52 participantsStarted 2019-06-12
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* HIV-1 seropositivity by rapid test, confirmed by enzyme-linked immunosorbent assay (regardless of Antiretroviral Therapy (ART) status);
* Age 18 years or older;
* Tuberculous meningitis defined as 'possible', 'probable' or 'definite' as per published case definitions
Exclusion Criteria:
* Rifampicin-resistant M. tb detected in any microbiological specimen;
* History of allergy or hypersensitivity to H, E, R and Z, LZD or ASA;
* Received more than 5 days of antitubercular therapy in the 30 days prior to screening;
* Received a dose of ASA or any other NSAID within 2 weeks of screening;
* CSF unobtainable by lumbar puncture or another procedure;
* Evidence of bacterial or cryptococcal meningitis;
* Severe concurrent uncontrolled opportunistic infection including but not limited to active cytomegalovirus-associated disease, Kaposi sarcoma, Pneumocystis jirovecii pneumonia, HIV related or unrelated malignancy or gastrointestinal bleeding;
* Any other form of immunosuppressive therapy including antineoplastic and biologic agents apart from corticosteroids;
* Is pregnant in the third trimester;
* Peripheral neuropathy scoring Grade 3 or above on Brief Peripheral Neuropathy Score
* Any disease or condition in which the use of the standard TB drugs or any of their components is contraindicated, including but not limited to allergy to any TB drug or their components;
* The presence of one or more of the following:
* Estimated glomerular filtration rate (eGF…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants in each arm who develop treatment related adverse events (AEs).