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

NCT ID: NCT04006704

Last Updated: 2021-07-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-10
• Study Completion Date: 2020-03-06

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.

Conditions

HIV-1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

D/C/F/TAF FDC placebo

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

D/C/F/TAF FDC placebo

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Pharmaceutica N.V., Belgium

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Pharmaceutica N.V., Belgium Clinical Trial

Role: STUDY_DIRECTOR

Janssen Pharmaceutica N.V., Belgium

Locations

Phoenix Children's Hospital

Phoenix, Arizona, United States

Emory University

Atlanta, Georgia, United States

St Jude Children's Research Hospital

Memphis, Tennessee, United States

University of Texas Health Science Center

Houston, Texas, United States

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, , Spain

Countries

United States; Spain

References

Van Hemelryck S, Van Landuyt E, Hufkens V, Vanveggel S. Assessment of swallowability and acceptability of scored darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed-dose combination (FDC) tablets in HIV-1-infected children aged >/=6 to <12 years, using matching placebo tablets: A randomized study. Antivir Ther. 2024 Apr;29(2):13596535241248282. doi: 10.1177/13596535241248282.

Reference Type: DERIVED

PMID: 38725258 (View on PubMed)

Related Links

https://www.clinicaltrialsregister.eu/ctr-search/trial/2019-001384-68/results

Link to results on EudraCT registry.

Other Identifiers

2019-001384-68

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

TMC114FD2HTX1006

Identifier Type: OTHER

Identifier Source: secondary_id

CR108636

Identifier Type: -

Identifier Source: org_study_id