title: Minocycline treatment for HIV-associated cognitive impairment: results from a randomized trial.
abstract: 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.
  
  
  CONCLUSIONS
  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.
authors: Department of Neurology, Johns Hopkins Bayview Medical Center, 4940 Eastern Ave., 301 Building, Suite 2100, Baltimore, MD 21224, USA. sacktor@jhmi.edu
authors: N
authors: N
authors: Sacktor
authors: S
authors: S
authors: Miyahara
authors: L
authors: L
authors: Deng
authors: S
authors: S
authors: Evans
authors: G
authors: G
authors: Schifitto
authors: B A
authors: BA
authors: Cohen
authors: R
authors: R
authors: Paul
authors: K
authors: K
authors: Robertson
authors: B
authors: B
authors: Jarocki
authors: K
authors: K
authors: Scarsi
authors: R W
authors: RW
authors: Coombs
authors: M C
authors: MC
authors: Zink
authors: A
authors: A
authors: Nath
authors: E
authors: E
authors: Smith
authors: R J
authors: RJ
authors: Ellis
authors: E
authors: E
authors: Singer
authors: J
authors: J
authors: Weihe
authors: S
authors: S
authors: McCarthy
authors: L
authors: L
authors: Hosey
authors: D B
authors: DB
authors: Clifford
mesh_terms: D000328:Adult; D003072:Cognition Disorders / Q000150:complications / Q000188:drug therapy* / Q000523:psychology*; D015331:Cohort Studies; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D015658:HIV Infections / Q000150:complications / Q000188:drug therapy* / Q000523:psychology*; D015497:HIV-1; D006801:Humans; D008297:Male; D008875:Middle Aged; D008911:Minocycline / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D008911:Minocycline