TY - JOUR
T1 - Lower-extremity dynamometry as a novel outcome measure in a double-blind, placebo-controlled, feasibility trial of intravenous immunoglobulin (IVIG) for HIV associated myelopathy
AU - Robinson-Papp, Jessica
AU - George, Mary Catherine
AU - Nmashie, Alexandra
AU - Weisz, Donald
AU - Simpson, David M.
N1 - Funding Information:
FUNDING: This investigator-initiated project was supported by a grant from CSL Behring. The project was also supported by Grant Number #UL1TR000067 from the National Center for Advancing Translational Sciences (NCATS), a component of the National Institutes of Health (NIH). The contents of this manuscript are solely the responsibility of the authors and do not necessarily represent the official views of NCATS or NIH. DISCLOSURES: The authors report no financial arrangements between any author and any company whose product or competing product plays a role in the manuscript. This manuscript discusses an unlabeled use of a commercial product: IVIG is not labeled for the treatment of HIV-associated myelopathy. CORRESPONDENCE: Jessica Robinson-Papp, MD, MS, FAAN; Email: jessica.robinson-papp@mssm.edu
Publisher Copyright:
© 2018, Matrix Medical Communications. All rights reserved.
PY - 2018/1/1
Y1 - 2018/1/1
N2 - Objective: Open-label data suggest that intravenous immunoglobulin (IVIG) might improve lower extremity strength in human immunodeficiency virus (HIV)-associated myelopathy (HIVM), a rare but debilitating neurologic complication of HIV. We sought to determine the feasibility of testing the efficacy of IVIG for HIVM more rigorously. Design: We conducted a randomized, double-blind, placebo-controlled feasibility trial of IVIG for HIVM, using dynamometry as an outcome measure (Clinical Trial No. NCT01561755). Setting: The study took place in an academic medical center in New York, New York Participants: Only 12 participants were enrolled in four years; critical impediments to the study were the rarity of patients with new HIVM diagnoses and prior exposure to IVIG in patients with an established diagnosis. Measurements: Dynamometry of hip flexion, knee flexion, and ankle dorsiflexion were measured; the HIV Dementia Motor Score (HDMS); and the two-minute timed walk test were utilized. Results: Recruitment was the major feasibility issue. Dynamometry was generally well-tolerated, had good test-retest reliability (r=0.71–0.86, p<0.02 for all muscle groups), and good inter-item reliability as judged by the correlations between the muscle groups (r=0.76-0.81, p=0.001–0.005). Dynamometry was valid and clinically meaningful based on its correlations with the HDMS and the two-minute timed walk test. Conclusion: We conclude that an adequately powered clinical trial of IVIG for HIVM would likely require a prolonged recruitment period and multiple participating sites. Lower limb dynamometry is a useful outcome measure for HIVM, which might also be useful in other HIV-related gait disorders.
AB - Objective: Open-label data suggest that intravenous immunoglobulin (IVIG) might improve lower extremity strength in human immunodeficiency virus (HIV)-associated myelopathy (HIVM), a rare but debilitating neurologic complication of HIV. We sought to determine the feasibility of testing the efficacy of IVIG for HIVM more rigorously. Design: We conducted a randomized, double-blind, placebo-controlled feasibility trial of IVIG for HIVM, using dynamometry as an outcome measure (Clinical Trial No. NCT01561755). Setting: The study took place in an academic medical center in New York, New York Participants: Only 12 participants were enrolled in four years; critical impediments to the study were the rarity of patients with new HIVM diagnoses and prior exposure to IVIG in patients with an established diagnosis. Measurements: Dynamometry of hip flexion, knee flexion, and ankle dorsiflexion were measured; the HIV Dementia Motor Score (HDMS); and the two-minute timed walk test were utilized. Results: Recruitment was the major feasibility issue. Dynamometry was generally well-tolerated, had good test-retest reliability (r=0.71–0.86, p<0.02 for all muscle groups), and good inter-item reliability as judged by the correlations between the muscle groups (r=0.76-0.81, p=0.001–0.005). Dynamometry was valid and clinically meaningful based on its correlations with the HDMS and the two-minute timed walk test. Conclusion: We conclude that an adequately powered clinical trial of IVIG for HIVM would likely require a prolonged recruitment period and multiple participating sites. Lower limb dynamometry is a useful outcome measure for HIVM, which might also be useful in other HIV-related gait disorders.
KW - Dynamometry
KW - Human immunodeficiency virus (HIV)
KW - Intravenous immunoglobulin (IVIG)
KW - Myelopathy
UR - http://www.scopus.com/inward/record.url?scp=85044766360&partnerID=8YFLogxK
M3 - Article
AN - SCOPUS:85044766360
SN - 2158-8333
VL - 15
SP - 28
EP - 32
JO - Innovations in Clinical Neuroscience
JF - Innovations in Clinical Neuroscience
IS - 1-2
ER -