Study to Assess the Acceptability of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Fixed-Dose Combination (FDC) Tablets in Human Immunodeficiency Virus Type 1 (HIV-1) Infected Pediatric Participants, Using Matching Placebo Tablets

Completed · Phase 1 · Has a placebo group

Conditions studied: HIV-1

In brief

The primary purpose of this study is to assess the ability to swallow the scored film-coated darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed-dose combination (FDC) tablet, irrespective of the mode of intake (whole and split tablet).

Key facts

Study ID

NCT04006704

Run by

Janssen Pharmaceutica N.V., Belgium

People needed

25

Starts

2019-10-10

Expected to finish

2020-03-06

Last updated by the study team

2021-07-06

Who can join

Age: 6 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have a body weight of at least 25 kilogram (kg) and less than (<) 40 kg
• Has documented chronic human immunodeficiency virus type 1 (HIV-1) infection
• Must be on a stable antiretroviral (ARV) regimen for at least 3 months prior to screening
• Has documented plasma HIV-1 ribonucleic acid (RNA) < 400 copies/milliliter (mL) within 6 months prior to screening
• Parent(s) or their legally acceptable representative must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to allow the child to participate in the study. Assent is also required of children capable of understanding the nature of the study (typically 7 years of age and older)

You may not qualify if…

• Any active condition (example, active oral infection [candidiasis], significant physical or psychological disease or other findings during screening) that could prevent the participant from swallowing, or limit or confound the protocol-specified assessments and outcomes or for which, in the opinion of the investigator, participation could compromise the safety or well-being of the participant
• Taking any disallowed therapies
• Is a family member of an employee or investigator of the study site with direct involvement in the proposed study or other studies under the direction of that investigator or study site, or is a family member of an employee of Johnson \& Johnson
• Have any known allergies to the excipients of the placebo tablet

Where it is running

• Phoenix Children's Hospital — Phoenix, Arizona, United States
• Emory University — Atlanta, Georgia, United States
• St Jude Children's Research Hospital — Memphis, Tennessee, United States
• University of Texas Health Science Center — Houston, Texas, United States
• Hosp. Sant Joan de Deu — Esplugues de Llobregat, Spain
• Hosp. Gral. Univ. Gregorio Marañon — Madrid, Spain
• Hosp. Univ. 12 de Octubre — Madrid, Spain
• Hosp. Univ. La Paz — Madrid, Spain

Full record on ClinicalTrials.gov

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