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Details

Autor(en) / Beteiligte
Titel
Timing of Initiation of Antiretroviral Therapy in Human Immunodeficiency Virus (HIV)—Associated Tuberculous Meningitis
Ist Teil von
  • Clinical infectious diseases, 2011-06, Vol.52 (11), p.1374-1383
Ort / Verlag
Oxford: Oxford University Press
Erscheinungsjahr
2011
Link zum Volltext
Quelle
Oxford Journals 2020 Medicine
Beschreibungen/Notizen
  • 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.
Sprache
Englisch
Identifikatoren
ISSN: 1058-4838
eISSN: 1537-6591
DOI: 10.1093/cid/cir230
Titel-ID: cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_4340579
Format
Schlagworte
Adult, AIDS, Anti-HIV Agents - administration & dosage, Anti-HIV Agents - adverse effects, Anti-Inflammatory Agents - administration & dosage, Antibiotics. Antiinfectious agents. Antiparasitic agents, Antiretroviral drugs, Antiretroviral Therapy, Highly Active - adverse effects, Antiretroviral Therapy, Highly Active - methods, Antiretrovirals, Antitubercular Agents - administration & dosage, Antiviral agents, Art therapy, Arts, Bacterial diseases, Bacterial diseases of the nervous system. Bacterial myositis, Benzoxazines - administration & dosage, Biological and medical sciences, Clinical trials, Dexamethasone - administration & dosage, Double-Blind Method, Female, HIV, HIV 1, HIV Infections - complications, HIV Infections - drug therapy, HIV Infections - mortality, HIV/AIDS, Human bacterial diseases, Human immunodeficiency virus, Human viral diseases, Humans, Infectious diseases, Lamivudine - administration & dosage, Male, Medical sciences, Medical treatment, Meningeal tuberculosis, Meningitis, Mortality, Pharmacology. Drug treatments, Placebos - administration & dosage, Random allocation, Risk assessment, Statistical median, Time Factors, Treatment Outcome, Trimethoprim, Sulfamethoxazole Drug Combination - administration & dosage, Tuberculosis, Meningeal - complications, Tuberculosis, Meningeal - drug therapy, Tuberculosis, Meningeal - mortality, Viral diseases, Viral diseases of the lymphoid tissue and the blood. Aids, Zidovudine - administration & dosage

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