Study to Assess the Acceptability/Swallowability of DRV-Containing FDC Tablets in HIV-1 Infected Adolescents, Using Matching Placebo Tablets

A Study to Assess the Acceptability/Swallowability of DRV-containing FDC Tablets in HIV-1 Infected Adolescents, Using Matching Placebo Tablets

The primary purpose of this study is to assess the acceptability of swallowing the darunavir/cobicistat (DRV/COBI) and darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed-dose combination (FDC) tablets, using matching placebo tablets, in human immunodeficiency virus (HIV) -1 infected adolescent patients.

Study Overview

• Status: Completed
• Conditions: HIV-1
• Intervention / Treatment: Drug: DRV/COBI FDC placebo tablet; Drug: D/C/F/TAF FDC placebo tablets

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Phoenix Children's Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30350
      • Emory University
  • Tennessee
    • Memphis, Tennessee, United States, 38105
      • St Jude Children's Research Hospital
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas Health Science Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Participant must be male or female between 12 to 17 years of age, inclusive
• Participant must have a body weight of at least 40 kilogram (kg)
• Informed consent must be obtained (from participant and/or his/her parent(s)/legal guardian, as applicable) and an age-appropriate Assent Form, as applicable, indicating that the purpose of, and procedures required for, the study are understood and that the participant is willing to participate in the study
• Participant must be able to comply with the protocol requirements, and adhere to prohibitions and restrictions specified in the protocol
• Participant has documented chronic human immunodeficiency virus (HIV) -1 infection, and is aware of his/her HIV-1 diagnosis
• Participant must be on a stable antiretroviral (ARV) regimen for at least 3 months and has documented plasma HIV-1 ribonucleic acid (RNA) less than (<) 50 copies/ milliLitre (mL) within 3 months prior to screening
• Participant must be willing to assess swallowability of the placebo tablets and be able to do so (as demonstrated by the intake of a reference placebo tablet)

Exclusion Criteria:

• Participant has any condition that, in the opinion of the Investigator, would compromise the study or the well-being of the participant, or prevent the participant from meeting or performing study requirements
• Participant has any condition that, in the opinion of the Investigator, could prevent, limit, or confound the protocol-specified assessments
• Participant has any active clinically significant physical or psychological disease or findings during screening that, in the Investigator's opinion, would compromise the participant's safety, ability to swallow (eg, candidiasis), or outcome of the study
• Participant has history of difficulty with oral intake of ARV therapy or other medications
• Participant is taking disallowed concomitant medications or over-the-counter products
• Participant is a family member of an employee or Investigator of the study site or Participant is a family member of an employee of Johnson & Johnson

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group 1: DRV/COBI Placebo followed by D/C/F/TAF Placebo; Participants will receive fixed dose combination (FDC) of darunavir/cobicistat (DRV/COBI) matching placebo tablets (Intake 1) and FDC of darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) matching placebo tablets (Intake 2) on Day 1. Both the intakes will be separated by at least 30 minutes.	Drug: DRV/COBI FDC placebo tablet; Participants will receive 1 placebo tablet matching the DRV/COBI 800/150 milligram (mg) FDC; Drug: D/C/F/TAF FDC placebo tablets; Participants will receive 1 placebo tablet matching the D/C/F/TAF 800/150/200/10 mg FDC.
EXPERIMENTAL: Group 2: D/C/F/TAF Placebo followed by DRV/COBI Placebo; Participants will receive FDC of D/C/F/TAF matching placebo tablets (Intake 1) and FDC of DRV/COBI matching placebo tablets (Intake 2) on Day 1. Both the intakes will be separated by at least 30 minutes.	Drug: DRV/COBI FDC placebo tablet; Participants will receive 1 placebo tablet matching the DRV/COBI 800/150 milligram (mg) FDC; Drug: D/C/F/TAF FDC placebo tablets; Participants will receive 1 placebo tablet matching the D/C/F/TAF 800/150/200/10 mg FDC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Acceptability of Swallowing Fixed-Dose Combination (FDC) Tablets in Human Immunodeficiency Virus (HIV)-1 Infected Adolescent Patients	Swallowability will be assessed based on a 7-point questionnaire indicating how difficult/easy it was to swallow the tablet, ranging from "very difficult" to "very easy". The acceptability proportion is obtained by a dichotomization of the acceptability/swallowability scale, i.e. 'slightly difficult' or worse versus 'neither difficult nor easy' or better.	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of Daily Intake of the FDC Tablets, by HIV-1 Infected Adolescent Participants	Acceptability for long term daily use will be assessed based on a 3-point questionnaire, 'not acceptable', 'acceptable', or 'good to take'.	Day 1

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC

Publications and helpful links

Helpful Links

• A study to assess the acceptability/swallowability of DRV-containing FDC tablets in HIV-1 infected adolescents, using matching placebo tablets

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 23, 2017
• Primary Completion (ACTUAL): May 25, 2017
• Study Completion (ACTUAL): May 25, 2017

Study Registration Dates

• First Submitted: December 13, 2016
• First Submitted That Met QC Criteria: December 13, 2016
• First Posted (ESTIMATE): December 15, 2016

Study Record Updates

• Last Update Posted (ACTUAL): May 13, 2019
• Last Update Submitted That Met QC Criteria: May 9, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: CR108265; TMC114FD2HTX1003 (OTHER: Janssen Research & Development, LLC); 2016-003016-12 (EUDRACT_NUMBER)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No