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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

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ClinicalTrials.gov Identifier: NCT04006704
Recruitment Status : Recruiting
First Posted : July 5, 2019
Last Update Posted : February 19, 2020
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutica N.V., Belgium

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).

Condition or disease Intervention/treatment Phase
HIV-1 Drug: D/C/F/TAF FDC placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
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
Actual Study Start Date : October 10, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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.

  3. 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').

  4. 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').

  5. 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').

  6. 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.

  7. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 11 Years   (Child)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04006704


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

Locations
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United States, Arizona
Phoenix Children's Hospital Recruiting
Phoenix, Arizona, United States, 85016
United States, District of Columbia
Children's National Medical Center Withdrawn
Washington, District of Columbia, United States, 20010
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30308
United States, Maryland
Johns Hopkins University Withdrawn
Baltimore, Maryland, United States, 21287
United States, New York
Jacobi Medical Center Withdrawn
Bronx, New York, United States, 10461
United States, Tennessee
St Jude Children's Research Hospital 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 Recruiting
Esplugues De Llobregat, Spain, 08950
Hosp. Gral. Univ. Gregorio Marañon Recruiting
Madrid, Spain, 28007
Hosp. Univ. 12 de Octubre Recruiting
Madrid, Spain, 28041
Hosp. Univ. La Paz Recruiting
Madrid, Spain, 28046
Sponsors and Collaborators
Janssen Pharmaceutica N.V., Belgium
Investigators
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Study Director: Janssen Pharmaceutica N.V., Belgium Clinical Trial Janssen Pharmaceutica N.V., Belgium

Additional Information:
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Responsible Party: Janssen Pharmaceutica N.V., Belgium
ClinicalTrials.gov Identifier: NCT04006704    
Other Study ID Numbers: CR108636
2019-001384-68 ( EudraCT Number )
TMC114FD2HTX1006 ( Other Identifier: Janssen Pharmaceutica N.V., Belgium )
First Posted: July 5, 2019    Key Record Dates
Last Update Posted: February 19, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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

URL: https://www.janssen.com/clinical-trials/transparency

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tenofovir
Emtricitabine
Darunavir
Cobicistat
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents
HIV Protease Inhibitors
Protease Inhibitors
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors