A Study to Assess the Acceptability of the Darunavir/Cobicistat (DRV/COBI) Fixed-dose Combination (FDC) Tablet in Human Immunodeficiency Virus (HIV)-1 Infected Children

Completed · Phase 1

Conditions studied: Human Immunodeficiency Virus (HIV)

In brief

The purpose of the study is to assess the ability to swallow the Darunavir/Cobicistat (DRV/COBI) fixed dosed combination (FDC) tablet dispersed in water.

Key facts

Study ID

NCT05197075

Run by

Janssen Research & Development, LLC

People needed

15

Starts

2022-08-03

Expected to finish

2022-09-23

Last updated by the study team

2023-09-14

Who can join

Age: 3 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Has documented chronic Human Immunodeficiency Virus (HIV-1) infection
• Must be on an allowed stable unchanged antiretroviral (ARV) regimen for at least 3 months prior to screening
• Has a documented plasma HIV-1 Ribonucleic acid (RNA) less than 400 copies/milliliters (mL) within 6 months prior to or at screening
• Must be in a condition that allows to perform the protocol-specified assessments and so must his/her caregiver, if applicable. If a participant and his or her caregiver have difficulties in completing the questionnaire, the study-site personnel may assist
• Body weight within greater than or equal to (>=) 15 kilograms (kg) to less than (<) 25 kg

You may not qualify if…

• Known allergies, hypersensitivity, or intolerance to Darunavir/Cobicistat (DRV/COBI) or any excipient of the study intervention
• Has taken any disallowed therapies
• 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 dispersions in water, or for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol specified assessments and outcomes
• Active acquired immunodeficiency syndrome (AIDS)-defining illness at screening
• Has had any contact with severe acute respiratory syndrome coronavirus 2 (SARS CoV 2) positive or Coronavirus Disease 2019 (COVID-19) participants within the last 2 weeks prior to admission to the clinical research center

Where it is running

• Emory University — Atlanta, Georgia, United States
• Rahima Moosa Mother and Child Hospital, University of Witwatersrand — Johannesburg, South Africa
• Global Clinical Trials PE — Pretoria, South Africa
• Hosp. Gral. Univ. Gregorio Maranon — Madrid, Spain
• Hosp. Clinico San Carlos — Madrid, Spain
• Hosp. Univ. La Paz — Madrid, Spain

Full record on ClinicalTrials.gov

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