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Completed

NCT Number: NCT02993237

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.

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Key information

Conditions

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Phoenix Children's Hospital, Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DRV/COBI FDC placebo tablet

Drug

Participants will receive 1 placebo tablet matching the DRV/COBI 800/150 milligram (mg) FDC

D/C/F/TAF FDC placebo tablets

Drug

Participants will receive 1 placebo tablet matching the D/C/F/TAF 800/150/200/10 mg FDC.

Primary outcomes

  1. 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 outcomes

  1. 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'.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Dec 15, 2016
Registry last updated
May 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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