Status:
COMPLETED
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
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Human Immunodeficiency Virus (HIV)
Eligibility:
All Genders
3+ years
Phase:
PHASE1
Brief 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.
Detailed Description
Human immunodeficiency virus type 1 (HIV-1) infection is a life-threatening and serious disease that is of major public health interest around the world. Standard-of-care for the treatment of HIV infe...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 23 2022
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05197075
Start Date
August 3 2022
End Date
September 23 2022
Last Update
September 14 2023
Active Locations (6)
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1
Emory University
Atlanta, Georgia, United States, 30308
2
Rahima Moosa Mother and Child Hospital, University of Witwatersrand
Johannesburg, South Africa, 2112
3
Global Clinical Trials PE
Pretoria, South Africa, 0001
4
Hosp. Gral. Univ. Gregorio Maranon
Madrid, Spain, 28007