Randomized trial of minocycline in the treatment of HIV-associated cognitive impairment
Open accessAbstract
OBJECTIVE: To evaluate the efficacy and safety of minocycline in the management of HIV-associated cognitive impairment. METHODS: We enrolled HIV-positive participants with a CD4 count of 250 to 500 cells/μL in a randomized, double-blind, placebo-controlled study. They received 100 mg of minocycline or matching placebo orally every 12 hours for 24 weeks. Cognitive function was measured using the Uganda neuropsychological test battery summary measure (U NP Sum) and the Memorial Sloan-Kettering (MSK) scale. The primary efficacy measure was the 24-week change in an average of 9 standardized U NP Sum z scores. RESULTS: Seventy-three participants were enrolled. Of these, 90% were female, 49% were between the ages 30 and 39 years, and 74% had 6 or more years of education. One participant had MSK score of stage 1 (i.e., mild HIV dementia), and 72 participants had MSK stage 0.5 (i.e., equivocal or subclinical dementia) at the baseline evaluation. The minocycline effect on the 24-week change of the U NP Sum compared with placebo was 0.03 (95% confidence interval -0.51, 0.46; p = 0.37). CONCLUSION: Minocycline was safe and well tolerated in HIV-positive individuals. However, it did not improve HIV-associated cognitive impairment. CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that 100 mg of minocycline given orally every 12 hours for 24 weeks had no significant effect compared with placebo in the improvement of cognitive function in antiretroviral therapy-naive, HIV-positive patients.
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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 [105]
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HIV-Associated Neurocognitive Disorders
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From Envelope to Encephalopathy: How HIV-1 gp120 Drives Neurocognitive Decline
Santerre, M., Shrestha, J., Allen, C. N. S., Shcherbik, N., & Sawaya, B. (2026) · Viruses · doi:10.3390/v18050495
New horizons in HIV neuropathogenesis: thinking beyond the brain
Angelovich, T. A., Busman‐Sahay, K., Eddine, J. J., Churchill, M. J., Okoye, A. A., & Estes, J. D. (2026) · Current Opinion in HIV and AIDS · doi:10.1097/coh.0000000000001052
- Authors
- Nakasujja, N., Miyahara, S., Evans, S., Lee, A., Musisi, S., Katabira, E., Robertson, K., Ronald, A., Clifford, D. B., & Sacktor, N.
- Affiliations
- University of North Carolina at Chapel Hill (US)
- ORCID
- Venue
- Neurology
- Published
- 2013-01-08
- Volume
- 80
- Issue
- 2
- Pages
- 196-202
- ISSN
- 0028-3878 (ISSN-L)
- 1526-632X
- PMC
- PMC3589188
- OpenAlex
- W2100154777
- Cited by
- 67
- References
- 31
- Citations by year
- 2026: 2 · 2025: 1 · 2024: 1 · 2023: 3 · 2022: 3 · 2021: 5 · 2020: 7 · 2019: 4 · 2018: 4 · 2017: 5 · 2016: 7 · 2015: 9 · 2014: 9 · 2013: 7
- FWCI
- 3.58
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Neurology (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Carolina Digital Repository (University of North Carolina at Chapel Hill) (submittedVersion)
- UNC Libraries
- Funders
- Pfizer
- Biogen
- National Institutes of Health
- National Institute on Aging
- National Institute of Mental Health
- National Institute of Allergy and Infectious Diseases
- National Institute of Neurological Disorders and Stroke (NS32228)
- 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 › Emergency Medicine › HIV-related health complications and treatments
- Keywords
- minocycline, HIV-associated cognitive impairment, HIV-associated dementia, cognitive function, drug safety and efficacy
- MeSH terms
- Activities of Daily Living, Adult, Anti-Bacterial Agents, Cognition Disorders, Depression, Double-Blind Method, Female, Humans, Male, Middle Aged, Minocycline, Neuropsychological Tests, Uganda, AIDS Dementia Complex, Treatment Outcome, Hyperpigmentation, Sample Size, Antiretroviral Therapy, Highly Active, Young Adult
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