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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 25, 2017

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Proportion of Acceptability of Swallowing Fixed-Dose Combination (FDC) Tablets in Human Immunodeficiency Virus (HIV)-1 Infected Adolescent Patients
    • Time Frame: Day 1
    • 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.

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 12 Years

Maximum Age: 17 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Janssen Research & Development, LLC
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Janssen Research & Development, LLC Clinical Trial, Study Director, Janssen Research & Development, LLC

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