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

NCT05197075 | Completed Phase 1 FDA Drug

• 3 other identifiers: CR1091462021-000738-32TMC114FD1HTX1001
• Study Type: interventional
• Target: 15
• Locations: 3 countries
• Sites: 6

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.

Conditions

Human Immunodeficiency Virus (HIV)

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants with Ability to Take the Darunavir/Cobicistat (DRV/COBI) Fixed Dosed Combination (FDC) Tablet Dispersed in Water as Reported by the Observer

  The percentage of participants that is able to swallow the medication fully versus partially or not at all, based on the questionnaire for the observer will be reported.

  Day 1

Secondary Outcomes (8)

• Ease of Swallowing of Tablet Dispersed in Water by the Participant

  Day 1

• Ease of Swallowing of Tablet Dispersed in Water by the Participant as Reported by the Caregiver

  Day 1

• Palatability of the Tablet Dispersed in Water by the Participant

  Day 1

• Palatability of the Tablet Dispersed in Water by the Participant as Reported by the Caregiver

  Day 1

• Ease of Dispersion of the Tablet in the Water as Reported by the Caregiver

  Day 1

Study Arms (1)

Darunavir/Cobicistat (DRV/COBI) Fixed Dose Combination (FDC)

EXPERIMENTAL

Participants will receive the DRV/COBI FDC tablet for oral use, dispersed in water on Day 1.

Drug: DRV/COBI FDC

Interventions

DRV/COBI FDC DRUG

DRV/COBI FDC tablet dispersed in water will be administered orally.

Also known as: TMC114/JNJ-48763364

Darunavir/Cobicistat (DRV/COBI) Fixed Dose Combination (FDC)

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (6)

Emory University

Atlanta, Georgia, 30308, United States

Location

Rahima Moosa Mother and Child Hospital, University of Witwatersrand

Johannesburg, 2112, South Africa

Location

Global Clinical Trials PE

Pretoria, 0001, South Africa

Location

Hosp. Gral. Univ. Gregorio Maranon

Madrid, 28007, Spain

Location

Hosp. Clinico San Carlos

Madrid, 28040, Spain

Location

Hosp. Univ. La Paz

Madrid, 28046, Spain

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Janssen Research and Development, LLC Clinical Trial

  Janssen Research and Development LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2022
• First Posted: January 19, 2022
• Study Start: August 3, 2022
• Primary Completion: September 23, 2022
• Study Completion: September 23, 2022
• Last Updated: September 14, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1); ES (3); ZA (2)