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.
RCT Entities:
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.
Authors: Gregory L Szeto; Angela K Brice; Hung-Chih Yang; Sheila A Barber; Robert F Siliciano; Janice E Clements Journal: J Infect Dis Date: 2010-04-15 Impact factor: 5.226
Authors: V Wee Yong; Jennifer Wells; Fabrizio Giuliani; Steven Casha; Christopher Power; Luanne M Metz Journal: Lancet Neurol Date: 2004-12 Impact factor: 44.182
Authors: N Sacktor; N Nakasujja; R Skolasky; K Robertson; M Wong; S Musisi; A Ronald; E Katabira Journal: Neurology Date: 2006-07-25 Impact factor: 9.910
Authors: Ned C Sacktor; Matthew Wong; Noeline Nakasujja; Richard L Skolasky; Ola A Selnes; Seggane Musisi; Kevin Robertson; Justin C McArthur; Allan Ronald; Elly Katabira Journal: AIDS Date: 2005-09-02 Impact factor: 4.177
Authors: Paul H Gordon; Dan H Moore; Robert G Miller; Julaine M Florence; Joseph L Verheijde; Carolyn Doorish; Joan F Hilton; G Mark Spitalny; Robert B MacArthur; Hiroshi Mitsumoto; Hans E Neville; Kevin Boylan; Tahseen Mozaffar; Jerry M Belsh; John Ravits; Richard S Bedlack; Michael C Graves; Leo F McCluskey; Richard J Barohn; Rup Tandan Journal: Lancet Neurol Date: 2007-11-05 Impact factor: 44.182
Authors: M Kloppenburg; B M Brinkman; H H de Rooij-Dijk; A M Miltenburg; M R Daha; F C Breedveld; B A Dijkmans; C Verweij Journal: Antimicrob Agents Chemother Date: 1996-04 Impact factor: 5.191
Authors: Kevin R Robertson; Marlene Smurzynski; Thomas D Parsons; Kunling Wu; Ronald J Bosch; Julia Wu; Justin C McArthur; Ann C Collier; Scott R Evans; Ron J Ellis Journal: AIDS Date: 2007-09-12 Impact factor: 4.177
Authors: Kevin R Robertson; Noeline Nakasujja; Matthew Wong; Seggane Musisi; Elly Katabira; Thomas D Parsons; Allan Ronald; Ned Sacktor Journal: BMC Neurol Date: 2007-04-05 Impact factor: 2.474
Authors: Kelly A Meulendyke; Ceereena Ubaida-Mohien; Julia L Drewes; Zhaohao Liao; Lucio Gama; Kenneth W Witwer; David R Graham; M Christine Zink Journal: J Infect Dis Date: 2014-03-31 Impact factor: 5.226
Authors: Joshua A Walker; Andrew D Miller; Tricia H Burdo; Michael S McGrath; Kenneth C Williams Journal: J Acquir Immune Defic Syndr Date: 2017-04-15 Impact factor: 3.731
Authors: Cari Fritz-French; Ramzi Shawahna; Jennifer E Ward; Leonard E Maroun; William R Tyor Journal: J Interferon Cytokine Res Date: 2014-02-24 Impact factor: 2.607