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



Status:Completed
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:12 - 17
Updated:8/8/2018
Start Date:January 2017
End Date:May 2017

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

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.


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
We found this trial at
4
sites
1919 E Thomas Rd
Phoenix, Arizona 85006
(602) 933-1000
Phoenix Children's Hospital Phoenix Children's Hospital has provided hope, healing, and the best healthcare for...
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Phoenix, AZ
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Atlanta, GA
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262 Danny Thomas Pl
Memphis, Tennessee 38105
(901) 495-3300
St. Jude Children's Research Hospital St. Jude is unlike any other pediatric treatment and research...
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from
Memphis, TN
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from
Houston, TX
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