Study of immediate versus deferred antiretroviral therapy in human immunodeficiency virus-associated tuberculous meningitis

Conditions

HIV-associated tuberculous meningitis Infections and Infestations Tuberculous meningitis

Török ME, Yen NT, Chau TT, Mai NT, Phu NH, Mai PP, Dung NT, Chau NV, Bang ND, Tien NA, Minh NH, Hien NQ, Thai PV, Dong DT, Anh DT, Thoa NT, Hai NN, Lan NN, Lan NT, Quy HT, Dung NH, Hien TT, Chinh NT, Simmons CP, de Jong M, Wolbers M, Farrar JJ.

2011-06-01218 citations

10.1093/cid/cir230

Interventions

Randomised double-blind placebo-controlled trial with two parallel arms: immediate Highly Active Anti-Retroviral Therapy (HAART) and deferred HAART (two months). Patients will also receive standard tr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients aged 15 or over 2. HIV seropositive 3. Anti-retroviral naive 4. Presenting with tuberculous meningitis

Exclusion criteria

Exclusion criteria: 1. Positive Cerebrospinal Fluid (CSF) Gram or India ink stain 2. Known or suspected pregnancy 3. Anti-tuberculous treatment eight to 30 days immediately prior to recruitment 4. Previous antiretroviral therapy 5. Laboratory contraindications to anti-retroviral or anti-tuberculous therapy 6. Lack of consent

Design outcomes

Primary

Measure	Time frame
Mortality at 9 months	—

Secondary

Measure	Time frame
1. Mortality at 12 months 2. Fever clearance time 3. Coma clearance time 4. Neurological relapse 5. Progression to new or recurrent Acquired Immuno-Deficiency Syndrome (AIDS) defining illness 6. Any grade three or four adverse event 7. CD4 count response 8. Plasma HIV-1 RiboNucleic Acid (RNA) response 9. Neurological disability: neurological disability will be assessed using the 'simple questions' and Rankin score	—

Measure

Time frame

1. Mortality at 12 months 2. Fever clearance time 3. Coma clearance time 4. Neurological relapse 5. Progression to new or recurrent Acquired Immuno-Deficiency Syndrome (AIDS) defining illness 6. Any grade three or four adverse event 7. CD4 count response 8. Plasma HIV-1 RiboNucleic Acid (RNA) response 9. Neurological disability: neurological disability will be assessed using the 'simple questions' and Rankin score

—

Countries

Viet Nam

Outcome results

None listed