A Phase 1 interventional study of D/C/F/TAF FDC placebo in HIV-1, sponsored by Janssen Pharmaceutica N.V., Belgium. Completed at 8 sites in 2 countries. Open to participants aged 6 Years to 11 Years. Per ClinicalTrials.gov, last updated 2021-07-06.
Sponsored by Janssen Pharmaceutica N.V., Belgium · Phase 1, Interventional, and Other
The primary purpose of this study is to assess the ability to swallow the scored film-coated darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed-dose combination (FDC) tablet, irrespective of the mode of intake (whole and split tablet).
This study will be performed in 24 human immunodeficiency virus type 1 (HIV-1) infected pediatric participants. This study is being conducted to obtain data needed to assist in further pediatric development of D/C/F/TAF by assessing the acceptability of the scored film-coated D/C/F/TAF FDC tablet administered as a matching placebo tablet in a pediatric population. At Day 1, each participant will sequentially take 2 placebo tablets and the sequence of placebo tablet, swallowed whole or as split tablet, is assigned by computer generated randomization. After each intake period (within 15 minutes and before the next intake period, as applicable), participants will be asked to fill out an acceptability questionnaires. Every attempt should be made for the participant to complete the questionnaire (marking the correct box to correspond with their impact of taking the placebo tablet). Caregivers may explain the wording/text in the questionnaire to aid in completion. If a participant and his or her caregiver have difficulties in completing the questionnaire, then the study-site personnel may assist. Primarily ability to swallow the scored film-coated D/C/F/TAF FDC tablet, irrespective of the mode of intake will be assessed. Participants safety will be evaluated throughout the study from signing of the Informed Consent Form (ICF)/Assent Form onwards until the last study-related visit.
Janssen Pharmaceutica N.V., Belgium is the lead sponsor of 58 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive scored film-coated 10 milligram (mg) FDC matching placebo tablets (Intake period 1) swallowed whole followed by FDC of scored film-coated D/C/F/TAF 675/150/200/10 mg matching placebo tablets (Intake period 2) swallowed as a split tablet on Day 1. Both the intakes will be separated by at least 15 minutes.
Drug: D/C/F/TAF FDC placebo
Participants will receive scored film-coated 10 mg FDC matching placebo tablets (Intake period 1) swallowed as a split tablet followed by FDC of scored film-coated D/C/F/TAF 675/150/200/10 mg matching placebo tablets (Intake period 2) swallowed whole on Day 1. Both the intakes will be separated by at least 15 minutes.
Drug: D/C/F/TAF FDC placebo
Participants will receive matching placebo tablet (whole and split) of D/C/F/TAF 675/150/200/10 mg FDC on Day 1 as intake period 1 and intake period 2.
Percentage of Participants who are Able to Swallow the Scored Film-Coated D/C/F/TAF FDC Tablet Irrespective of Mode of Intake
Ability to swallow the scored film-coated tablet irrespective of mode of intake (whole or split tablet) will be assessed.
Time frame: Day 1
Acceptability of Intake of the Whole Tablet by the Participant and by the Caregiver
Acceptability of intake of whole tablet will be assessed based on a 3-point questionnaire indicating how hard/easy it is to swallow the tablet, ('hard', 'neither hard or easy','easy') to take this pill.
Time frame: Day 1
Acceptability of Intake of the Split Tablet by the Participant and by the Caregiver
Acceptability of intake of split tablet will be assessed based on a 3-point questionnaire indicating how difficult/easy it was to swallow the tablet ('hard', 'neither hard or easy', 'easy') to take the 2 pieces of this pill.
Time frame: Day 1
Acceptability of Daily Intake of the Whole Tablet by the Participant
Acceptability of whole tablet describing how it would be if to take this pill once daily for a longer period ('Not Acceptable', 'Acceptable', 'Good to take' to 'Unable to assess this question').
Time frame: Day 1
Acceptability of Daily Intake of the Split Tablet by the Participant
Acceptability of Split tablet describing how it would be if to take this pill once daily for a longer period ("Not Acceptable', 'Acceptable', 'Good to take' to 'Unable to assess this question').
Time frame: Day 1
Ease of Splitting the Tablet by the Participant's Caregiver
Ease of splitting the tablet by participant's caregiver will be assessed based on a 3- point questionnaire indicating how difficult was it for the participant's caregiver to break the tablet by hand ('hard', 'ok','easy').
Time frame: Day 1
Number of Participants with Swallowing Difficulties as Reported by the Observer
Number of Participants with swallowing difficulties as reported by the observer.
Time frame: Day 1
Number of Participants with Adverse Events
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Time frame: Up to 22 Days
Plan to share: Yes — The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu
This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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Janssen Pharmaceutica N.V., Belgium