期刊
NEUROLOGY
卷 77, 期 12, 页码 1135-1142出版社
LIPPINCOTT WILLIAMS & WILKINS
DOI: 10.1212/WNL.0b013e31822f0412
关键词
-
资金
- AIDS Clinical Trials Group (ACTG)
- NIAID [AI38858, AI38855, AI27670, AI27668, AI27658, AI34853, AI127660, AI27664, AI27659, AI25903, AI25915, AI046376, AI46370, AI46381, AI50410, AI25868, AI46386, CFAR AI 127757]
- Neurologic AIDS Research Consortium [NS32228]
- National Institute of Mental Health [MH71150, MH64409, AI 068634]
- National Center for Research Resources (NCRR) [RR00052, RR00044, RR00046]
- University of California, San Diego Antiviral Research [AI069432]
- Johns Hopkins University [AI069465]
- CTSA [UL1 RR025005]
- UCLA School of Medicine [AI069424]
- Washington University (St. Louis) [AI069495]
- The Research & Education Group-Portland CRS [AI069503]
- Henry Ford Hospital CRS [AI069503]
- Massachusetts General Hospital [AI069472]
- NYU/NYC HHC at Bellevue [AI069532]
- University of Colorado Hospital [AI069450]
- Northwestern University [AI069471]
- Virginia Commonwealth University Medical Center CRS [AI069503]
- University of Washington (Seattle) [AI069434]
- University of North Carolina [AI069423]
- University of Rochester Medical Center [AI069511]
- Emory University
- The Ponce de Leon Center [AI069452]
- University of Pennsylvania, Philadelphia [AI069467-04]
- National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services [N01-AI-05414]
- National Institute of Allergy and Infectious Diseases [AI068636]
- National Institute of Mental Health (NIMH)
- National Institute of Dental and Craniofacial Research (NIDCR)
- Neurologic AIDS Research Consortium
- Statistical and Data Management Center of the Adult AIDS Clinical Trials Group
- Oral HIV/AIDS Research Alliance
- Biogen Idec
- Bristol-Myers Squibb
- EMD Serono, Inc.
- Novartis
- sanofi-aventis
- GlaxoSmithKline
- Abbott
- Tibotec Therapeutics
- NIH (NIAID and Fogarty International Center)
- Department of Health and Human Services
- Ralph and Marion Falk
- Society of Infectious Diseases Pharmacists
- NIH (NIAID/DAIDS)
- NIH (NINDS, NIMH)
- Pfizer Inc
- Millennium Pharmaceuticals, Inc.
- Genentech Inc.
- Schering-Plough Corp.
- Bavarian Nordic
- NeurogesX
- Boehringer Ingelheim
- Gilead Sciences, Inc.
Objective: We conducted a study of minocycline to assess its safety, tolerability, and efficacy for the treatment of HIV-associated cognitive impairment. Methods: HIV-1-infected individuals with progressive neurocognitive decline were enrolled in a double-blind, placebo-controlled study of minocycline. Participants were randomized to receive minocycline 100 mg or matching placebo orally every 12 hours. The primary efficacy measure was change in a neuropsychological test composite z score (NPZ-8) from baseline to week 24. Measures of safety included the frequency of adverse events and changes over time in laboratory tests. After 50% of participants completed the double-blind phase, an interim analysis of futility for the primary outcome measure was performed, and our Data and Safety Monitoring Board recommended early study termination. Results: A total of 107 HIV-1-infected individuals with cognitive impairment were enrolled. The minocycline group did not show improvement in the primary outcome measure (NPZ-8) (mean 24-week change = 0.12) compared to placebo (mean 24-week change = 0.17) (95% confidence interval = [-0.26, 0.39], p = 0.70). There were few severe adverse events or laboratory abnormalities in either treatment group. Conclusion: Minocycline was safe and well-tolerated in individuals with HIV-associated cognitive impairment, but cognitive improvement was not observed. Classification of evidence. This interventional study provides Class II evidence for the safety, tolerability, and efficacy of minocycline for the treatment of HIV-associated cognitive impairment. Neurology (R) 2011;77:1135-1142
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据