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

HIV-1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02993237
• Other study ID #: CR108265
• Secondary ID: TMC114FD2HTX1003
• Status: Completed
• Phase: Phase 1
• Start date: January 23, 2017
• Est. completion date: May 25, 2017

Study information

• Verified date: May 2019
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: May 25, 2017
• Est. primary completion date: May 25, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV-1

Intervention

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

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	University of Texas Health Science Center	Houston	Texas
United States	St Jude Children's Research Hospital	Memphis	Tennessee
United States	Phoenix Children's Hospital	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

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