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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: HIV-1

Treatments: Drug: DRV/COBI FDC placebo tablet; Drug: D/C/F/TAF FDC placebo tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT02993237

2016-003016-12 (EudraCT Number)

TMC114FD2HTX1003 (Other Identifier)

CR108265

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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27 participants in 2 patient groups

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

Experimental group

Description:

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.

Treatment:

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 group

Description:

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.

Treatment:

Drug: DRV/COBI FDC placebo tablet

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