Study to Assess the Acceptability/Swallowability of DRV-C... | NCT02993237

ID	Type	Description	Link
TMC114FD2HTX1003	Other Identifier	Janssen Research & Development, LLC
2016-003016-12	EudraCT Number

Status Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Eligibility Module

Eligibility Criteria

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

Facility	Status	City	State	ZIP	Country	Contacts
Phoenix Children's Hospital		Phoenix	Arizona	85016	United States
Emory University