Publication:
Timing of Initiation of Antiretroviral Therapy in Human Immunodeficiency Virus (HIV)-Associated Tuberculous Meningitis

dc.contributor.author Simmons, Cameron
dc.date.accessioned 2018-09-14T11:14:59Z
dc.date.available 2017-07-12T04:47:43Z
dc.date.available 2018-09-14T11:14:59Z
dc.date.issued 2011-06-01 en_US
dc.description.abstract BACKGROUND: The optimal time to initiate antiretroviral therapy (ART) in human immunodeficiency virus (HIV)-associated tuberculous meningitis is unknown. METHODS: We conducted a randomized, double-blind, placebo-controlled trial of immediate versus deferred ART in patients with HIV-associated tuberculous meningitis to determine whether immediate ART reduced the risk of death. Antiretroviral drugs (zidovudine, lamivudine, and efavirenz) were started either at study entry or 2 months after randomization. All patients were treated with standard antituberculosis treatment, adjunctive dexamethasone, and prophylactic co-trimoxazole and were followed up for 12 months. We conducted intention-to-treat, per-protocol, and prespecified subgroup analyses. RESULTS: A total of 253 patients were randomized, 127 in the immediate ART group and 126 in the deferred ART group; 76 and 70 patients died within 9 months in the immediate and deferred ART groups, respectively. Immediate ART was not significantly associated with 9-month mortality (hazard ratio [HR], 1.12; 95% confidence interval [CI], .81-1.55; P = .50) or the time to new AIDS events or death (HR, 1.16; 95% CI, .87-1.55; P = .31). The percentage of patients with severe (grade 3 or 4) adverse events was high in both arms (90% in the immediate ART group and 89% in the deferred ART group; P = .84), but there were significantly more grade 4 adverse events in the immediate ART arm (102 in the immediate ART group vs 87 in the deferred ART group; P = .04). CONCLUSIONS: Immediate ART initiation does not improve outcome in patients presenting with HIV-associated tuberculous meningitis. There were significantly more grade 4 adverse events in the immediate ART arm, supporting delayed initiation of ART in HIV-associated tuberculous meningitis. Clinical Trials Registration. ISRCTN63659091.
dc.identifier.uri https://demo7.dspace.org/handle/123456789/147
dc.language English en_US
dc.title Timing of Initiation of Antiretroviral Therapy in Human Immunodeficiency Virus (HIV)-Associated Tuberculous Meningitis en_US
dc.type Journal Article
dspace.entity.type Publication
relation.isAuthorOfPublication b1b2c768-bda1-448a-a073-fc541e8b24d9
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