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- Title
Timing of Initiation of Antiretroviral Therapy in Human Immunodeficiency Virus (HIV)--Associated Tuberculous Meningitis.
- Authors
Török, M. Estee; Nguyen Thi Bich Yen; Tran Thi Hong Chau; Nguyen Thi Hoang Mai; Nguyen Hoan Phu; Pham Phuong Mai; Nguyen Thi Dung; Nguyen Van Vinh Chau; Nguyen Duc Bang; Nguyen Anh Tien; Minh, N.H.; Nguyen Quang Hien; Phan Vuong Khac Thai; Doan The Dong; Do Thi Tuong Anh; Nguyen Thi Cam Thoa; Nguyen Ngoc. Hai; Nguyen Ngoc Lan; Nguyen Thi Ngoc Lan; Hoang Thi Quy
- 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, perprotocol, 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.
- Subjects
HIV; ANTIRETROVIRAL agents; MENINGITIS; TUBERCULOSIS patients; CENTRAL nervous system diseases; CO-trimoxazole
- Publication
Clinical Infectious Diseases, 2011, Vol 52, Issue 11, p1374
- ISSN
1058-4838
- Publication type
Article
- DOI
10.1093/cid/cir230