Minocycline treatment for HIV-associated cognitive impairment: Results from a randomized trial
Open accessAbstract
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. ACTG= : AIDS Clinical Trials Group; ADC= : AIDS Dementia Complex; ALS= : amyotrophic lateral sclerosis; CALCAP= : California Computerized Assessment Package; CES-D= : Center for Epidemiologic Studies Depression Scale; HAART= : highly active antiretroviral therapy; HAND= : HIV-associated neurocognitive disorder; HVLT-R= : Hopkins Verbal Learning Test Revised; MS= : multiple sclerosis; NPZ-8= : neuropsychological z score; WAIS-R= : Wechsler Adult Intelligence Scale–Revised.
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Two separate RCTs on HIV-1-infected individuals with progressive neurocognitive decline reported that adjunctive minocycline for 24 weeks was not associated with significant improvements in cognitive performance.
“Two separate RCTs on HIV-1-infected individuals with progressive neurocognitive decline reported that treatment with adjunctive minocycline for 24 weeks was not associated with significant improvements in cognitive performance [105, 106].”
From Cognitive remission: a novel objective for the treatment of major depression? (2016) · cites this paper as [106]
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Minocycline differentially modulates human spatial memory systemsPreprint
Bird, C. M., Harrison, N. A., & Berens, S. C. (2020) · OSF Preprints (OSF Preprints)
- Authors
- Sacktor, N., Miyahara, S., Deng, L., Evans, S., Schifitto, G., Cohen, B. A., Paul, R., Robertson, K., Jarocki, B., Scarsi, K., Coombs, R. W., Zink, M. C., Nath, A., Smith, E., Ellis, R. J., Singer, E., Weihe, J., McCarthy, S., Hosey, L., & Clifford, D. B.
- Affiliations
- Northwestern University (US)
- ORCID
- Venue
- Neurology
- Published
- 2011-09-20
- Volume
- 77
- Issue
- 12
- Pages
- 1135-1142
- ISSN
- 0028-3878 (ISSN-L)
- 1526-632X
- PMC
- PMC3174065
- OpenAlex
- W1985096210
- Cited by
- 87
- References
- 41
- Citations by year
- 2026: 3 · 2025: 4 · 2024: 6 · 2023: 3 · 2021: 6 · 2020: 10 · 2019: 5 · 2018: 3 · 2017: 4 · 2016: 7 · 2015: 7 · 2014: 10 · 2013: 11 · 2012: 7
- FWCI
- 3.67
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Neurology (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- U.S. Department of Health and Human Services
- Bristol-Myers Squibb
- Pfizer
- GlaxoSmithKline
- Sanofi
- Massachusetts General Hospital
- Gilead Sciences
- Biogen
- Teva Pharmaceutical Industries
- University of Pennsylvania
- Emory University
- Northwestern University
- University of Washington
- Johns Hopkins University (RR025005)
- University of Rochester (AI069511)
- Virginia Commonwealth University
- Acorda Therapeutics
- Georgia Clinical and Translational Science Alliance
- Elan
- Astellas Pharma
- Astellas Foundation for Research on Metabolic Disorders
- Bavarian Nordic
- National Institutes of Health (n01ai005414-001, AI069503, AI 068636, AI069465, AI069450, AI069423, RR025005, AI069424, AI069467, AI069511, AI069434, AI069452, AI069432, AI069471, AI069495, AI069472, AI069532)
- Genentech
- EMD Serono
- Forest Laboratories
- Medical Center, University of Rochester
- Takeda Oncology
- National Institute on Aging
- National Institute of Mental Health (MH 71150, R01MH064409, R01MH071150, MH-64409)
- National Institute on Drug Abuse
- National Cancer Institute
- National Institute of Allergy and Infectious Diseases (U01AI027658, AI38858, U01AI046386, AI 27668, AI-069511, AI 069423, AI46386, AI 069432, U01AI046376, AI068634, AI069503, AI50410, AI-069434, AI-27664, AI 46370, AI-069495, AI38855, AI-069450, AI069472, AI-069532, AI2-7659, AI46381, U01AI025903, AI 069471, AI 069452, U01AI038855, AI069465, AI-068636, U01AI025868, AI 27658, AI 046376, U01AI046370, AI069467-04, AI25915-, AI127660, U01AI038858, AI-25903, AI-34853, U01AI027670, AI2-7670, AI 069424, U01AI034853, U01AI025915, AI 25868, U01AI027659, U01AI027668, N01-AI-05414, U01AI046381, P30AI050410, U01AI027664)
- Fogarty International Center
- National Institute of Neurological Disorders and Stroke (NS32228)
- National Institute of Dental and Craniofacial Research (AI069432)
- National Center for Research Resources (RR-00044, UL1RR025005, RR00046, RR 000 52, M01RR000046, M01RR000044)
- Topics
- Life Sciences › Immunology and Microbiology › Virology › HIV Research and Treatment
- Health Sciences › Medicine › Infectious Diseases › HIV/AIDS drug development and treatment
- Health Sciences › Medicine › Surgery › Infectious Diseases and Tuberculosis
- Keywords
- minocycline, HIV-associated cognitive impairment, HIV-associated neurocognitive disorders, HIV-associated dementia, neurocognitive decline, drug safety and tolerability, treatment efficacy
- MeSH terms
- Adult, Cognition Disorders, Double-Blind Method, Female, Follow-Up Studies, Humans, Male, Middle Aged, Minocycline, Cohort Studies, HIV-1, HIV Infections, Treatment Outcome
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