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

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 Aged >=3 Years and Weighing >=15 kg to <25 kg

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.

Study Overview

• Status: Completed
• Conditions: Human Immunodeficiency Virus (HIV)
• Intervention / Treatment: Drug: DRV/COBI FDC

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 infection involves the use of a combination of antiretroviral (ARV) drugs to suppress viral replication to below detectable limits, to increase CD4+ cell count, and to delay disease progression. Darunavir (DRV) is an inhibitor of the dimerization and of the catalytic activity of the HIV-1 protease. It selectively inhibits the cleavage of HIV encoded Gag-Pol polyproteins in virus infected cells, thereby preventing the formation of mature infectious virus particles. Cobicistat (COBI) is a mechanism-based inhibitor (MBI) of the cytochrome P450 (CYP)3A subfamily. Inhibition of CYP3A mediated metabolism by COBI enhances the systemic exposure of CYP3A substrates, such as DRV, where bioavailability is limited and half-life is shortened by CYP3A-dependent metabolism. DRV/COBI FDC tablet formulation would overcome the difficulties of pediatric participants (greater than or equal to [>=] 3 years and weighing >=15 kilograms [kg] to less than [<] 25 kg) might encounter in swallowing a whole or 2 halves of an oral, non-disintegrating tablet, hence helping children to better adhere to their HIV treatment. The study consists of a screening phase (up to 21 days) and an open-label administration phase of 1 day. Safety will be assessed by adverse events (AEs). The total duration of the study is up to 32 days.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 1

Contacts and Locations

Study Locations

• South Africa
  • Johannesburg, South Africa, 2112
    • Rahima Moosa Mother and Child Hospital, University of Witwatersrand
  • Pretoria, South Africa, 0001
    • Global Clinical Trials PE
• Spain
  • Madrid, Spain, 28040
    • Hosp. Clinico San Carlos
  • Madrid, Spain, 28046
    • Hosp. Univ. La Paz
  • Madrid, Spain, 28007
    • Hosp. Gral. Univ. Gregorio Maranon
• United States
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Emory University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Darunavir/Cobicistat (DRV/COBI) Fixed Dose Combination (FDC); Participants will receive the DRV/COBI FDC tablet for oral use, dispersed in water on Day 1.	Drug: DRV/COBI FDC; DRV/COBI FDC tablet dispersed in water will be administered orally.; Other Names: TMC114/JNJ-48763364

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ease of Swallowing of Tablet Dispersed in Water by the Participant	Ease of Swallowing of tablet dispersed in water by the participant will be assessed by using 5-point hedonic scale acceptability questionnaire to be completed by the participant indicating how difficult/easy it is to swallow the tablet dispersed in water (very difficult, difficult, ok, easy, and very easy).	Day 1
Ease of Swallowing of Tablet Dispersed in Water by the Participant as Reported by the Caregiver	Ease of Swallowing of tablet dispersed in water by the participant will be assessed by using 5-point hedonic scale acceptability questionnaire to be completed by the caregiver on the basis of reaction/ facial expression of the participant, indicating how difficult/easy it is for the participant to swallow the tablet dispersed in water (very difficult, difficult, ok, easy, and very easy).	Day 1
Palatability of the Tablet Dispersed in Water by the Participant	Palatability of tablet dispersed in water by the participant will be assessed by using 5-point hedonic scale acceptability questionnaire indicating the taste of the tablet dispersed in water (dislike very much, dislike a little, not sure, like a little, like a lot).	Day 1
Palatability of the Tablet Dispersed in Water by the Participant as Reported by the Caregiver	Palatability of tablet dispersed in water by the participant will be assessed by using 5-point hedonic scale acceptability questionnaire to be completed by the caregiver on the basis of reaction/ facial expression of the participant, indicating how the participant like the taste of the tablet dispersed in water (dislike very much, dislike a little, not sure, like a little, like a lot).	Day 1
Ease of Dispersion of the Tablet in the Water as Reported by the Caregiver	Ease of dispersion of the tablet in the water will be assessed by using 5-point hedonic scale acceptability questionnaire to be completed by the caregiver, indicating how difficult/easy it is to disperse the tablet in water (very difficult, difficult, ok, easy, and very easy).	Day 1
Acceptability of Taking the Tablet Dispersed in Water Everyday by the Participant	Acceptability of taking the tablet dispersed in water everyday by the participant will be assessed by using 5-point hedonic scale acceptability questionnaire indicating how difficult/easy it is to take the tablet everyday (very difficult, difficult, ok, easy, and very easy).	Day 1
Acceptability of Taking the Tablet Dispersed in Water Everyday by the Participant as Reported by the Caregiver	Acceptability of taking the tablet dispersed in water everyday by the participant will be assessed by using 5-point hedonic scale acceptability questionnaire to be completed by the caregiver, indicating how difficult/easy it is for the participant to take the tablet everyday (very difficult, difficult, ok, easy, and very easy).	Day 1
Number of Participants with Adverse Event	An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.	Up to 32 days

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research and Development, LLC Clinical Trial, Janssen Research and Development LLC

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2022
• Primary Completion (Actual): September 23, 2022
• Study Completion (Actual): September 23, 2022

Study Registration Dates

• First Submitted: January 17, 2022
• First Submitted That Met QC Criteria: January 17, 2022
• First Posted (Actual): January 19, 2022

Study Record Updates

• Last Update Posted (Actual): September 14, 2023
• Last Update Submitted That Met QC Criteria: September 13, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immune System Diseases; Slow Virus Diseases; Urogenital Diseases; Genital Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Immunologic Deficiency Syndromes; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Protease Inhibitors; HIV Protease Inhibitors; Viral Protease Inhibitors; Darunavir
• Other Study ID Numbers: CR109146; 2021-000738-32 (EudraCT Number); TMC114FD1HTX1001 (Other Identifier: Janssen Research and Development, LLC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No