title: Randomized trial of minocycline in the treatment of HIV-associated cognitive impairment.
abstract: 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).
  
  
  CONCLUSIONS
  Minocycline was safe and well tolerated in HIV-positive individuals. However, it did not improve HIV-associated cognitive impairment.
  
  
  METHODS
  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.
authors.affiliation: College of Health Sciences, Makerere University, Kampala, Uganda. drnoeline@yahoo.com
authors.forename: Noeline
authors.initials: N
authors.lastname: Nakasujja
authors.forename: Sachiko
authors.initials: S
authors.lastname: Miyahara
authors.forename: Scott
authors.initials: S
authors.lastname: Evans
authors.forename: Anthony
authors.initials: A
authors.lastname: Lee
authors.forename: Seggane
authors.initials: S
authors.lastname: Musisi
authors.forename: Elly
authors.initials: E
authors.lastname: Katabira
authors.forename: Kevin
authors.initials: K
authors.lastname: Robertson
authors.forename: Allan
authors.initials: A
authors.lastname: Ronald
authors.forename: David B
authors.initials: DB
authors.lastname: Clifford
authors.forename: Ned
authors.initials: N
authors.lastname: Sacktor
mesh_terms: D015526:AIDS Dementia Complex / Q000188:drug therapy* / Q000523:psychology; D000203:Activities of Daily Living; D000328:Adult; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active; D003072:Cognition Disorders / Q000188:drug therapy* / Q000209:etiology / Q000523:psychology; D003863:Depression / Q000209:etiology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D017495:Hyperpigmentation / Q000139:chemically induced; D008297:Male; D008875:Middle Aged; D008911:Minocycline / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D009483:Neuropsychological Tests; D018401:Sample Size; D016896:Treatment Outcome; D014454:Uganda; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D008911:Minocycline