D/C/F/TAF FDC placebo
DrugParticipants 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.
NCT Number: NCT04006704
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).
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Notify Me6 year–11 year
All sexes
Interventional
Phase 1
Hosp. Sant Joan de Deu, Esplugues de Llobregat, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Day 1
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 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 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 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 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 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.
Time frame: Up to 22 Days
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.
Janssen Pharmaceutica N.V., Belgium
Industry
A Study to Assess the Acceptability of Scored Film-coated Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Fixed-dose Combination (FDC) Tablets in HIV 1 Infected Pediatric Participants Aged ≥6 to <12 Years, Using Matching Placebo Tablets
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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