期刊
CLINICAL INFECTIOUS DISEASES
卷 56, 期 8, 页码 1165-1173出版社
OXFORD UNIV PRESS INC
DOI: 10.1093/cid/cit019
关键词
HIV-1; cryptococcal meningitis; randomized controlled trial; Africa; highly active antiretroviral therapy (HAART)
资金
- Doris Duke Charitable Foundation via a Doris Duke Clinical Scientist Development Award
- Penn Center for AIDS Research International Core
Background. The burden of Cryptococcus neoformans in cerebrospinal fluid (CSF) predicts clinical outcomes in human immunodeficiency virus (HIV)-associated cryptococcal meningitis (CM) and is lower in patients on antiretroviral therapy (ART). This study tested the hypothesis that initiation of ART during initial treatment of HIV/CM would improve CSF clearance of C. neoformans. Methods. A randomized treatment-strategy trial was conducted in Botswana. HIV-infected, ART-naive adults aged >= 21 years initiating amphotericin B treatment for CM were randomized to ART initiation within 7 (intervention) vs after 28 days (control) of randomization, and the primary outcome of the rate of CSF clearance of C. neoformans over the subsequent 4 weeks was compared. Adverse events, including CM immune reconstitution inflammatory syndrome (CM-IRIS), and immunologic and virologic responses were compared over 24 weeks. Results. Among 27 subjects enrolled (14 control and 13 intervention), the median times to ART initiation were 7 (interquartile range [IQR], 5-10) and 32 days (IQR, 28-36), respectively. The estimated rate of CSF clearance did not differ significantly by treatment strategy (-0.32 log(10) colony-forming units [CFU]/mL/day +/- 0.20 intervention and -0.52 log(10) CFUs/mL/day (+/- 0.48) control, P = .4). Two of 13 (15%) and 5 of 14 (36%) subjects died in the intervention and control arms, respectively (P = 0.39). Seven of 13 subjects (54%) in the intervention arm vs 0 of 14 in the control arm experienced CM-IRIS (P = .002). Conclusions. Early ART was not associated with improved CSF fungal clearance, but resulted in a high risk of CM-IRIS. Further research on optimal incorporation of ART into CM care is needed.
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