Clinical trial NCT04006704: Study to Assess the Acceptability of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Fixed-Dose Combination (FDC) Tablets in Human Immunodeficiency Virus Type 1 (HIV-1) Infected Pediatric Participants, Using Matching Placebo Tablets
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV-1
Lead sponsor: Janssen Pharmaceutica N.V., Belgium
Sponsor class: INDUSTRY
First posted: 2019-07-05
Enrollment: 25
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Have a body weight of at least 25 kilogram (kg) and less than (\<) 40 kg
* Has documented chronic human immunodeficiency virus type 1 (HIV-1) infection
* Must be on a stable antiretroviral (ARV) regimen for at least 3 months prior to screening
* Has documented plasma HIV-1 ribonucleic acid (RNA) \< 400 copies/milliliter (mL) within 6 months prior to screening
* Parent(s) or their legally acceptable representative must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to allow the child to participate in the study. Assent is also required of children capable of understanding the nature of the study (typically 7 years of age and older)

Exclusion Criteria:

* Any active condition (example, active oral infection \[candidiasis\], significant physical or psychological disease or other findings during screening) that could prevent the participant from swallowing, or limit or confound the protocol-specified assessments and outcomes or for which, in the opinion of the investigator, participation could compromise the safety or well-being of the participant
* Taking any disallowed therapies
* Is a family member of an employee or investigator of the study site with direct involvement in the proposed study or other studies under the direction of that investigator or study site, or is a family member of an employee of Johnson \& Johnson
* Have any known allergies to the excipients of the placebo tablet

Primary outcomes:
measure: Percentage of Participants who are Able to Swallow the Scored Film-Coated D/C/F/TAF FDC Tablet Irrespective of Mode of Intake
timeFrame: Day 1
Secondary outcomes:
measure: Acceptability of Intake of the Whole Tablet by the Participant and by the Caregiver
timeFrame: Day 1
measure: Acceptability of Intake of the Split Tablet by the Participant and by the Caregiver
timeFrame: Day 1
measure: Acceptability of Daily Intake of the Whole Tablet by the Participant
timeFrame: Day 1
measure: Acceptability of Daily Intake of the Split Tablet by the Participant
timeFrame: Day 1
measure: Ease of Splitting the Tablet by the Participant's Caregiver
timeFrame: Day 1
measure: Number of Participants with Swallowing Difficulties as Reported by the Observer
timeFrame: Day 1
measure: Number of Participants with Adverse Events
timeFrame: Up to 22 Days
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Children's Hospital
state: Arizona
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Memphis
country: United States
facility: St Jude Children's Research Hospital
state: Tennessee
city: Houston
country: United States
facility: University of Texas Health Science Center
state: Texas
city: Esplugues De Llobregat
country: Spain
facility: Hosp. Sant Joan de Deu
city: Madrid
country: Spain
facility: Hosp. Gral. Univ. Gregorio Marañon
city: Madrid
country: Spain
facility: Hosp. Univ. 12 de Octubre
city: Madrid
country: Spain
facility: Hosp. Univ. La Paz
Study officials:
affiliation: Janssen Pharmaceutica N.V., Belgium
name: Janssen Pharmaceutica N.V., Belgium Clinical Trial
role: STUDY_DIRECTOR
References: