Linezolid, Aspirin and Enhanced Dose Rifampicin in HIV-TBM

PHASE2CompletedINTERVENTIONAL
Enrollment

52

Participants

Timeline

Start Date

June 12, 2019

Primary Completion Date

March 30, 2021

Study Completion Date

March 31, 2021

Conditions
Tuberculosis MeningitisHIV-1-infection
Interventions
DRUG

Linezolid

For both experimental arms: 1.2g linezolid 28 days, followed by 600mg linezolid for 28 days

DRUG

High dose rifampicin

For both experimental arms: additional 25mg/kg (making a total of 35mg/kg) rifampicin, for the first 56 days of treatment

DRUG

Aspirin

For only one of the experimental arms: 1000mg of aspirin daily for 56 days.

DRUG

Standard of Care anti-tuberculous therapy

10mg/kg oral rifampicin, 5mg/kg oral isoniazid, 15mg/kg oral ethambutol, 25mg/kg oral pyrazinamide daily for 56 days.

DRUG

Dexamethasone

Dexamethasone according to doses of Thwaites criteria for the first 8 weeks of anti-tuberculous treatment. Doses differ according to participants Medical Research Council (MRC) grade. Given orally if participant can swallow and intravenously if they cannot.

Trial Locations (4)

6020

Livingstone Hospital, Port Elizabeth

7786

Mitchells Plain Hospital, Cape Town

7925

Groote Schuur Hospital, Cape Town

8001

New Somerset Hospital, Cape Town

All Listed Sponsors
lead

University of Cape Town

OTHER

NCT03927313 - Linezolid, Aspirin and Enhanced Dose Rifampicin in HIV-TBM | Biotech Hunter | Biotech Hunter