Quality Assessment for Therapeutic Drug Monitoring in AIDS Clinical Trials Group (ACTG 5146): A Multicenter Clinical Trial
Year: 2010
Type: article
Abstract: In a randomized trial, AIDS Clinical Trials Group (ACTG) protocol 5146 (A5146) investigated the use of therapeutic drug monitoring (TDM) to adjust doses of HIV-1 protease inhibitors (PIs) in patients with prior virologic failure on PI-based therapy who were starting a new PI-based regimen. The overall percentage of "PI trough repeats" such as rescheduled visits or redrawn PI trough specimens increased from 2% to 5% to 10% as the process progressed from the clinical sites, the pharmacology specialty laboratory, and the study team, respectively. Cumulatively, this represents a 17% rate of failure to obtain adequate PI trough sample. While targeting a turnaround of 7 days or less from sample receipt to a drug concentration report, 12% of the received specimens required a longer period to report concentrations. The implementation of dosing changes in the TDM arm were achieved within 7 days or less for 56% of the dose change events and within 14 days or less for 77% of dose change events. This quality assurance analysis provides a valuable summary of the specific points in the TDM process that could be improved during a multicenter clinical trial including: 1) shortening the timeline of sample shipment from clinical site to the laboratory; 2) performing the collection of PI trough specimen within the targeted sampling window by careful monitoring of the last dose times and collection times by the clinicians; 3) increasing patient adherence counseling to reduce the number of samples that are redrawn due to suspecting inconsistent adherence; and 4) decreasing the time to successful TDM-based dose adjustment. The application of some of these findings may also be relevant to single-center studies or clinical TDM programs within a hospital.
Source: Therapeutic Drug Monitoring
Authors: Robin DiFrancesco, Susan Rosenkranz, A Lisa Mukherjee, Lisa M Demeter, Hongyu Jiang, Robert DiCenzo, Carrie Dykes, Alex Rinehart, Mary Albrecht, Gene D Morse
Language: English
Subfield: Physiology
Field: Medicine
Domain: Health Sciences
Open Access status: green
Awards: Units for HIV/AIDS Clinical Trials Networks, G1103822763, G1114177658, G1116104148, G1118287939, G1158897216, G1158968046, G1163454436, G1169301292, G1177975577, G1225594167, G1237938092, G1249552884, G1276011396, G1342852236, G1346130624, G1486391454, G1586133245, WASHINGTON UNIVERSITY AIDS CLINICAL TRIALS UNIT, G16708505, G1678638035, G174905615, G183157880, Vanderbilt HIV Clinical Trials Unit, G1865158448, G193111053, G1939689254, G2027736814, G2069435444, G2075248984, G2093356446, G2127051194, G2135258891, G2241242742, G229144670, G2370685347, G2381598486, G2682253789, G2714926446, G2833553957, G2936172085, G2987980373, G3142995538, G3206931443, G3483687112, G3525517067, G374818150, G3763291967, Novel broad spectrum vaccination against influenza, Philadelphia IMPAACT Clinical Trials Unit, G4143780631, G4205250407, G4553935269, G4557896364, G4649361189, G485556598, General Clinical Research Center, University of Pittsburgh Clinical Trials Unit, ADULT THERAPEUTIC CLINICAL TRIALS PROGRAM IN AIDS, G5381804673, G5469398932, G5588634031, G57951046, UCSD Department of Medicine HIV/AIDS Clinical Trials Unit, Case AIDS Clinical Trials Unit, G6103943158, G610496905, G650174051, University of Cincinnati AIDS Clinical Trials Unit- UC ACTU, G6687940712, UCSF HIV Clinical Trials Unit, G7348756, HAWAII ACTU - ADULT THERAPEUTIC CLINICAL TRIALS PROGRAM, G7435995084, G7528714807, G7754564054, G83299872, G8474576350, G8487837538, Institute of Human Virology Clinical Trials Unit, G878552033, G8838841438, G9000015816, Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections, Center for AIDS Research at Emory University, Penn Center for AIDS Research, The University of North Carolina Center for AIDS Research, G926868656, Colorado Clinical and Translational Science Institute (UL1)
OpenAlex ID: W1978197575