NCT01442428 - Paradoxical Tuberculosis Immune Reconstitution Inflammatory Syndrome (TB-IRIS) Treatment Trial | Biotech Hunter

Timeline

Start Date

January 31, 2014

Primary Completion Date

March 31, 2016

Study Completion Date

June 30, 2016

Conditions

Immune Reconstitution Inflammatory SyndromeImmune Reconstitution SyndromeTuberculosisHIV-infection/Aids

Interventions

DRUG

Dexamethasone

Dexamethasone: 4 mg 3x daily for 2 weeks, then 2x daily for 1 week, then once daily for 1 week

DRUG

Atorvastatin

Atorvastatin: 80 mg once daily (equivalent to 30mg ± 10mg with rifamycin co-administration in this TB population)

DRUG

Naproxen

Naproxen: 250 mg 3x daily for 2 weeks, then 2x daily for 1 week, then once daily for 1 week

DRUG

Placebo

Atorvastatin placebo

Trial Locations (3)

Ramathibodi Hospital, Bangkok

Chiang Mai University, Chiang Mai

Bamrasnaradura Infectious Diseases Institute, Nonthaburi