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. 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.
Subject(s)
Cognition Disorders/drug therapy , Cognition Disorders/psychology , HIV Infections/drug therapy , HIV Infections/psychology , HIV-1 , Minocycline/therapeutic use , Adult , Cognition Disorders/complications , Cohort Studies , Double-Blind Method , Female , Follow-Up Studies , HIV Infections/complications , Humans , Male , Middle Aged , Treatment OutcomeABSTRACT
Record linkage is becoming an increasingly important technique in moni toring health outcomes. In this study we wought to examine the feasibility of linking mortality data held by the Registry of Birth, Deaths and Marriages with the Patient Master Index (PMI) at St. Vincent's Hospital, Melbourne, in order to document deaths soon after hospital discharge. Linkage was carried out using demographic details. Registry data required extensive editing and formatting prior to being matched with the PMI. 86.2% of cases identified by the computer algorithm were actual cases. Mortality data are an important source of information on health outcome but a process is needed to make them more usable. We have described one such method and suggested where the process could have been streamlined. The use of unique identifiers would have facilitated the matching process, curtailing several processing steps.
