Characterizing patterns of drug-taking behavior with a multiple drug regimen in an AIDS clinical trial.
OBJECTIVE
To characterize drug-taking behavior using continuous electronic monitoring in an AIDS clinical trial.


METHODS
This was a substudy of AIDS Clinical Trials Group (ACTG) protocol 175, a phase II/III study of dideoxynucleoside monotherapy versus combination therapy in asymptomatic HIV-positive subjects. Participants were required to comply with regimens containing zidovudine, zalcitabine and didanosine, or matching placebos; the total daily pill count was 16.


METHODS
For participants at two ACTG 175 sites, electronic devices were used to monitor drug-taking behavior of all study medications over a period of approximately 90 days.


METHODS
Four indices of drug-taking behavior were calculated and their distributions and relationship to the prescribed regimen were examined.


RESULTS
Data from 41 subjects were analyzed. Of the prescribed doses of zidovudine, zalcitabine and didanosine, 88, 84 and 82%, respectively, were taken. Of these, 55, 66 and 79%, respectively, were taken at the prescribed dosing frequency. The median percentage of days on which participants failed to take any of the doses was 2-5%. There was a trend towards lower adherence in the combination therapy arms compared with those assigned to receive monotherapy. In this analysis, older patients demonstrated better adherence, although patient characteristics, in general, were poorly predictive of adherence.


CONCLUSIONS
Drug-taking behavior for all three active study medications differed from that prescribed. One result of this erratic adherence was that study participants sustained little antiretroviral effect during more than 25% of the monitoring period.
Kastrissios
H
H
Division of Clinical Pharmacology, Stanford University School of Medicine, California 94305-5130, USA.
Suárez
J R
JR
Katzenstein
D
D
Girard
P
P
Sheiner
L B
LB
Blaschke
T F
TF
D000163:Acquired Immunodeficiency Syndrome / Q000188:drug therapy*; D000328:Adult; D000368:Aged; D019380:Anti-HIV Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D016049:Didanosine / Q000008:administration & dosage* / Q000627:therapeutic use; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D018894:Reverse Transcriptase Inhibitors / Q000008:administration & dosage* / Q000627:therapeutic use; D013997:Time Factors; D016047:Zalcitabine / Q000008:administration & dosage* / Q000627:therapeutic use; D015215:Zidovudine / Q000008:administration & dosage* / Q000627:therapeutic use
D019380:Anti-HIV Agents; D018894:Reverse Transcriptase Inhibitors; D015215:Zidovudine; D016047:Zalcitabine; D016049:Didanosine