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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

Primary Purpose

Human Immunodeficiency Virus (HIV)

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
DRV/COBI FDC
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Human Immunodeficiency Virus (HIV)

Eligibility Criteria

3 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Emory University
  • Rahima Moosa Mother and Child Hospital, University of Witwatersrand
  • Global Clinical Trials PE
  • Hosp. Gral. Univ. Gregorio Maranon
  • Hosp. Clinico San Carlos
  • Hosp. Univ. La Paz

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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).
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).
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).
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).
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).
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).
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.

Full Information

First Posted
January 17, 2022
Last Updated
September 13, 2023
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05197075
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
August 3, 2022 (Actual)
Primary Completion Date
September 23, 2022 (Actual)
Study Completion Date
September 23, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus (HIV)

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Darunavir/Cobicistat (DRV/COBI) Fixed Dose Combination (FDC)
Arm Type
Experimental
Arm Description
Participants will receive the DRV/COBI FDC tablet for oral use, dispersed in water on Day 1.
Intervention Type
Drug
Intervention Name(s)
DRV/COBI FDC
Other Intervention Name(s)
TMC114/JNJ-48763364
Intervention Description
DRV/COBI FDC tablet dispersed in water will be administered orally.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Ease of Swallowing of Tablet Dispersed in Water by the Participant
Description
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).
Time Frame
Day 1
Title
Ease of Swallowing of Tablet Dispersed in Water by the Participant as Reported by the Caregiver
Description
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).
Time Frame
Day 1
Title
Palatability of the Tablet Dispersed in Water by the Participant
Description
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).
Time Frame
Day 1
Title
Palatability of the Tablet Dispersed in Water by the Participant as Reported by the Caregiver
Description
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).
Time Frame
Day 1
Title
Ease of Dispersion of the Tablet in the Water as Reported by the Caregiver
Description
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).
Time Frame
Day 1
Title
Acceptability of Taking the Tablet Dispersed in Water Everyday by the Participant
Description
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).
Time Frame
Day 1
Title
Acceptability of Taking the Tablet Dispersed in Water Everyday by the Participant as Reported by the Caregiver
Description
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).
Time Frame
Day 1
Title
Number of Participants with Adverse Event
Description
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.
Time Frame
Up to 32 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research and Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research and Development LLC
Official's Role
Study Director
Facility Information:
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Rahima Moosa Mother and Child Hospital, University of Witwatersrand
City
Johannesburg
ZIP/Postal Code
2112
Country
South Africa
Facility Name
Global Clinical Trials PE
City
Pretoria
ZIP/Postal Code
0001
Country
South Africa
Facility Name
Hosp. Gral. Univ. Gregorio Maranon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hosp. Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hosp. Univ. La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

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

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