The primary purpose of this study is to assess the acceptability of swallowing the darunavir/cobicistat (DRV/COBI) and darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed-dose combination (FDC) tablets, using matching placebo tablets, in human immunodeficiency virus (HIV) -1 infected adolescent patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
27
Participants will receive 1 placebo tablet matching the DRV/COBI 800/150 milligram (mg) FDC
Participants will receive 1 placebo tablet matching the D/C/F/TAF 800/150/200/10 mg FDC.
Phoenix Children's Hospital
Phoenix, Arizona, United States
Emory University
Atlanta, Georgia, United States
St Jude Children's Research Hospital
Memphis, Tennessee, United States
University of Texas Health Science Center
Houston, Texas, United States
Proportion of Acceptability of Swallowing Fixed-Dose Combination (FDC) Tablets in Human Immunodeficiency Virus (HIV)-1 Infected Adolescent Patients
Swallowability will be assessed based on a 7-point questionnaire indicating how difficult/easy it was to swallow the tablet, ranging from "very difficult" to "very easy". The acceptability proportion is obtained by a dichotomization of the acceptability/swallowability scale, i.e. 'slightly difficult' or worse versus 'neither difficult nor easy' or better.
Time frame: Day 1
Acceptability of Daily Intake of the FDC Tablets, by HIV-1 Infected Adolescent Participants
Acceptability for long term daily use will be assessed based on a 3-point questionnaire, 'not acceptable', 'acceptable', or 'good to take'.
Time frame: Day 1
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