Clinical trial NCT02993237: Study to Assess the Acceptability/Swallowability of DRV-Containing FDC Tablets in HIV-1 Infected Adolescents, Using Matching Placebo Tablets
Official title: A Study to Assess the Acceptability/Swallowability of DRV-containing FDC Tablets in HIV-1 Infected Adolescents, Using Matching Placebo Tablets
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV-1
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2016-12-15
Enrollment: 27
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Proportion of Acceptability of Swallowing Fixed-Dose Combination (FDC) Tablets in Human Immunodeficiency Virus (HIV)-1 Infected Adolescent Patients
timeFrame: Day 1
Secondary outcomes:
measure: Acceptability of Daily Intake of the FDC Tablets, by HIV-1 Infected Adolescent Participants
timeFrame: Day 1
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Children's Hospital
state: Arizona
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Memphis
country: United States
facility: St Jude Children's Research Hospital
state: Tennessee
city: Houston
country: United States
facility: University of Texas Health Science Center
state: Texas
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: