Overview

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

Status:
Not yet recruiting
Trial end date:
2023-02-28
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Janssen Research & Development, LLC
Treatments:
Darunavir
Criteria
Inclusion Criteria

- 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

Exclusion criteria

- 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