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

HIV-1 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04006704
• Other study ID #: CR108636
• Secondary ID: 2019-001384-68TM
• Status: Completed
• Phase: Phase 1
• Start date: October 10, 2019
• Est. completion date: March 6, 2020

Study information

• Verified date: June 2021
• Source: Janssen Pharmaceutica N.V., Belgium
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 6, 2020
• Est. primary completion date: March 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV-1

Intervention

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.

Locations

Country	Name	City	State
Spain	Hosp. Sant Joan de Deu	Esplugues De Llobregat
Spain	Hosp. Gral. Univ. Gregorio Marañon	Madrid
Spain	Hosp. Univ. 12 de Octubre	Madrid
Spain	Hosp. Univ. La Paz	Madrid
United States	Emory University	Atlanta	Georgia
United States	University of Texas Health Science Center	Houston	Texas
United States	St Jude Children's Research Hospital	Memphis	Tennessee
United States	Phoenix Children's Hospital	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Pharmaceutica N.V., Belgium

Countries where clinical trial is conducted

United States,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 1
Secondary	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.	Day 1
Secondary	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.	Day 1
Secondary	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').	Day 1
Secondary	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').	Day 1
Secondary	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').	Day 1
Secondary	Number of Participants with Swallowing Difficulties as Reported by the Observer	Number of Participants with swallowing difficulties as reported by the observer.	Day 1
Secondary	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.	Up to 22 Days

External Links

•   Link to results on EudraCT registry.