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

NCT04006704 | Completed Phase 1 FDA Drug

• 3 other identifiers: CR1086362019-001384-68TMC114FD2HTX1006
• Study Type: interventional
• Target: 25
• Locations: 2 countries
• Sites: 8

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).

Conditions

HIV-1

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Acceptability of Intake of the Whole Tablet by the Participant and by the Caregiver

  Day 1

• Acceptability of Intake of the Split Tablet by the Participant and by the Caregiver

  Day 1

• Acceptability of Daily Intake of the Whole Tablet by the Participant

  Day 1

• Acceptability of Daily Intake of the Split Tablet by the Participant

  Day 1

• Ease of Splitting the Tablet by the Participant's Caregiver

  Day 1

Study Arms (2)

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

Interventions

D/C/F/TAF FDC placebo 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); D/C/F/TAF (Whole Placebo Tablet then Split Placebo Tablet)

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Pharmaceutica N.V., Belgium: lead

Study Sites (8)

Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States

Location

Emory University

Atlanta, Georgia, 30308, United States

Location

St Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

University of Texas Health Science Center

Houston, Texas, 77030, United States

Location

Hosp. Sant Joan de Deu

Esplugues de Llobregat, 08950, Spain

Location

Hosp. Gral. Univ. Gregorio Marañon

Madrid, 28007, Spain

Location

Hosp. Univ. 12 de Octubre

Madrid, 28041, Spain

Location

Hosp. Univ. La Paz

Madrid, 28046, Spain

Location

Related Publications (1)

• 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.

  PMID: 38725258 DERIVED

Related Links

• Link to results on EudraCT registry.

Study Officials

• Janssen Pharmaceutica N.V., Belgium Clinical Trial

  Janssen Pharmaceutica N.V., Belgium

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2019
• First Posted: July 5, 2019
• Study Start: October 10, 2019
• Primary Completion: March 6, 2020
• Study Completion: March 6, 2020
• Last Updated: July 6, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share

Locations

US (4); ES (4)