Clinical Trials

MainTitle

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

This study is not yet open for participant recruitment. (see Contacts and Locations)

Verified September 2019 by Janssen Pharmaceutica N.V., Belgium

Sponsor
Janssen Pharmaceutica N.V., Belgium


Information provided by (Responsible Party)
Janssen Pharmaceutica N.V., Belgium
ClinicalTrials.gov Identifier
NCT04006704

First received: July 2, 2019
Last updated: September 30, 2019
Last Verified: September 2019
History of Changes
Purpose

Purpose

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).

Condition Intervention Phase
HIV-1

Drug : D/C/F/TAF FDC placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Further study details as provided by Janssen Pharmaceutica N.V., Belgium:

Primary Outcome Measures

  • Percentage of Participants who are Able to Swallow the Scored Film-Coated D/C/F/TAF FDC Tablet Irrespective of Mode of Intake [ Time Frame: Day 1 ]
    Ability to swallow the scored film-coated tablet irrespective of mode of intake (whole or split tablet) will be assessed.
Secondary Outcome Measures:
  • Acceptability of Intake of the Whole Tablet by the Participant and by the Caregiver [ 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.
  • Acceptability of Intake of the Split Tablet by the Participant and by the Caregiver [ 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.
  • Acceptability of Daily Intake of the Whole Tablet by the Participant [ 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').
  • Acceptability of Daily Intake of the Split Tablet by the Participant [ 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').
  • Ease of Splitting the Tablet by the Participant's Caregiver [ 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').
  • Number of Participants with Swallowing Difficulties as Reported by the Observer [ Time Frame: Day 1 ]
    Number of Participants with swallowing difficulties as reported by the observer.
  • Number of Participants with Adverse Events [ 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.

Estimated Enrollment: 24
Study Start Date: October 16, 2019
Estimated Study Completion Date: June 30, 2020
Estimated Primary Completion Date: June 30, 2020 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: D/C/F/TAF (Whole Placebo Tablet then Split Placebo Tablet)
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 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.

Experimental: D/C/F/TAF (Split Placebo Tablet then Whole Placebo Tablet)
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.

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

Eligibility

Ages Eligible for Study: 6 Years to 11 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT04006704

Contacts

Contact:   Study Contact 844-434-4210 JNJ.CT@sylogent.com

Locations

United States, Arizona
Phoenix Children's Hospital Not yet recruiting
Phoenix, Arizona, United States, 85016
United States, District of Columbia
Children's National Medical Center Not yet recruiting
Washington, District of Columbia, United States, 20010
United States, Georgia
Emory University Not yet recruiting
Atlanta, Georgia, United States, 30350
United States, Maryland
Johns Hopkins University Not yet recruiting
Baltimore, Maryland, United States, 21287
United States, Tennessee
St Jude Children's Research Hospital Not yet recruiting
Memphis, Tennessee, United States, 38105
United States, Texas
University of Texas Health Science Center Not yet recruiting
Houston, Texas, United States, 77030
Spain
Hosp. Sant Joan de Deu Not yet recruiting
Esplugues De Llobregat, Spain, 08950
Hosp. Gral. Univ. Gregorio Maranon Not yet recruiting
Madrid, Spain, 28007
Hosp. Univ. 12 de Octubre Not yet recruiting
Madrid, Spain, 28041
Hosp. Univ. La Paz Not yet recruiting
Madrid, Spain, 28046

Sponsors and Collaborators

Janssen Pharmaceutica N.V., Belgium

Investigators

Study Director: Janssen Pharmaceutica N.V., Belgium Clinical Trial Janssen Pharmaceutica N.V., Belgium
More Information

More Information


Responsible Party: Janssen Pharmaceutica N.V., Belgium  
ClinicalTrials.gov Identifier: NCT04006704   History of Changes  
Other Study ID Numbers: CR108636  
  2019-001384-68  
  TMC114FD2HTX1006  
Study First Received: July 2, 2019  
Last Updated: September 30, 2019  
Individual Participant Data    
Plan to Share IPD: Yes  

Studies a U.S. FDA-regulated Drug Product: Yes  
Studies a U.S. FDA-regulated Device Product: No  

Additional relevant MeSH terms:
Tenofovir
Emtricitabine
Darunavir
Cobicistat

ClinicalTrials.gov processed this data on October 15, 2019
This information is provided by ClinicalTrials.gov.