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

NCT02993237 | Completed Phase 1 FDA Drug

• 3 other identifiers: CR108265TMC114FD2HTX10032016-003016-12
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 4

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.

Conditions

HIV-1

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Acceptability of Daily Intake of the FDC Tablets, by HIV-1 Infected Adolescent Participants

  Day 1

Study Arms (2)

Group 1: DRV/COBI Placebo followed by D/C/F/TAF Placebo

EXPERIMENTAL

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; Drug: D/C/F/TAF FDC placebo tablets

Group 2: D/C/F/TAF Placebo followed by DRV/COBI Placebo

EXPERIMENTAL

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; Drug: D/C/F/TAF FDC placebo tablets

Interventions

DRV/COBI FDC placebo tablet DRUG

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

Group 1: DRV/COBI Placebo followed by D/C/F/TAF Placebo; Group 2: D/C/F/TAF Placebo followed by DRV/COBI Placebo

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.

Group 1: DRV/COBI Placebo followed by D/C/F/TAF Placebo; Group 2: D/C/F/TAF Placebo followed by DRV/COBI Placebo

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (4)

Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States

Location

Emory University

Atlanta, Georgia, 30350, 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

Related Links

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

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  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: December 13, 2016
• First Posted: December 15, 2016
• Study Start: January 23, 2017
• Primary Completion: May 25, 2017
• Study Completion: May 25, 2017
• Last Updated: May 13, 2019

Record last verified: 2019-05

Locations

US (4)