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

Phase 1

Completed

• Conditions: HIV-1
• Interventions: Drug: DRV/COBI FDC placebo tablet; Drug: D/C/F/TAF FDC placebo tablets

• Registration Number: NCT02993237
• Lead Sponsor: Janssen Research & Development, LLC

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-12-13
• Study First Submitted QC: 2016-12-13
• Study First Posted: 2016-12-15
• Study Start: 2017-01-23
• Primary Completion: 2017-05-25
• Study Completion: 2017-05-25
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-09
• Last Update Posted: 2019-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 1: DRV/COBI Placebo followed by D/C/F/TAF Placebo	DRV/COBI FDC placebo tablet	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.
Group 1: DRV/COBI Placebo followed by D/C/F/TAF Placebo	D/C/F/TAF FDC placebo tablets	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.
Group 2: D/C/F/TAF Placebo followed by DRV/COBI Placebo	DRV/COBI FDC placebo tablet	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.
Group 2: D/C/F/TAF Placebo followed by DRV/COBI Placebo	D/C/F/TAF FDC placebo tablets	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.

Primary Outcome Measures

Name	Time	Method
Proportion of Acceptability of Swallowing Fixed-Dose Combination (FDC) Tablets in Human Immunodeficiency Virus (HIV)-1 Infected Adolescent Patients	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 Outcome Measures

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

Trial Locations

Locations (4)

Phoenix Children's Hospital; 🇺🇸 Phoenix, Arizona, United States

St Jude Children's Research Hospital; 🇺🇸 Memphis, Tennessee, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

University of Texas Health Science Center; 🇺🇸 Houston, Texas, United States