Clinical Trial Results:
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
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Summary
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EudraCT number |
2021-000738-32 |
Trial protocol |
ES Outside EU/EEA |
Global end of trial date |
23 Sep 2022
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Results information
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Results version number |
v1(current) |
This version publication date |
07 Apr 2023
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First version publication date |
07 Apr 2023
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
TMC114FD1HTX1001
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Janssen-Cilag International N.V.
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Sponsor organisation address |
Turnhoutseweg 30, Beerse, Belgium, B-2340
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Public contact |
Clinical Registry Group, Janssen-Cilag International N.V., ClinicalTrialsEU@its.jnj.com
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Scientific contact |
Clinical Registry Group, Janssen-Cilag International N.V., ClinicalTrialsEU@its.jnj.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
Yes
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EMA paediatric investigation plan number(s) |
EMEA-001280-PIP01-12 | ||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
23 Sep 2022
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
23 Sep 2022
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
Main objective of the trial was to assess, as part of the acceptability, the ability to swallow a single dose of the 600/90 milligrams (mg) DRV/COBI FDC tablet dispersed in water.
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Protection of trial subjects |
This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices and applicable regulatory requirements.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
11 Aug 2022
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Spain: 5
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Country: Number of subjects enrolled |
United States: 3
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Country: Number of subjects enrolled |
South Africa: 4
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Worldwide total number of subjects |
12
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EEA total number of subjects |
5
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
12
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||
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Pre-assignment
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Screening details |
A total of 12 HIV-1 infected children subjects were enrolled and treated in the study. | ||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||
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Arms
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Arm title
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DRV/COBI FDC 600/90mg | ||||||
Arm description |
HIV-infected subjects received a single dose of the DRV 600 mg and COBI 90 mg in a FDC tablet formulation dispersed in water once orally on Day 1. | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Cobicistat
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects were administered with single fixed dose of Cobicistat (COBI) 90 mg dispersed in water on Day 1.
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Investigational medicinal product name |
Darunavir
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects were administered with single fixed dose of Darunavir (DRV) 600 mg dispersed in water on Day 1.
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Baseline characteristics reporting groups
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Reporting group title |
DRV/COBI FDC 600/90mg
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Reporting group description |
HIV-infected subjects received a single dose of the DRV 600 mg and COBI 90 mg in a FDC tablet formulation dispersed in water once orally on Day 1. | ||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
DRV/COBI FDC 600/90mg
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Reporting group description |
HIV-infected subjects received a single dose of the DRV 600 mg and COBI 90 mg in a FDC tablet formulation dispersed in water once orally on Day 1. | ||
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End point title |
Percentage of Subjects With Ability to Swallow the Darunavir/Cobicistat (DRV/COBI) Fixed Dosed Combination (FDC) Tablet Dispersed in Water as Reported by Observer [1] | ||||||||
End point description |
Percentage of subjects with ability to swallow the DRV/COBI FDC tablet dispersed in water as reported by observer were reported. The subject's observer was given an acceptability questionnaire to assess about how the subject had taken the tablet dispersed in water and were asked to respond on the responses “fully”, “partially” and “not at all”. Only the category in which at least 1 subject had data were reported. Intent to treat (ITT) population included all subjects who were enrolled and received at least partial study intervention.
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End point type |
Primary
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End point timeframe |
Day 1
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No formal hypothesis testing was planned in this study. The statistical analysis was based upon descriptive statistics. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Ease of Swallowing of Tablet Dispersed in Water Reported by Subject | ||||||||||||||||
End point description |
An acceptability questionnaire was used to assess the ease of swallowing of tablet dispersed in water by the subject. Subjects were asked to indicate how difficult/easy it was to swallow the tablet dispersed in water on a 5-point hedonic scale: very difficult, difficult, Ok, easy, very easy. Only the category in which at least 1 subject had data were reported. Percentage of subjects with ease of swallowing of tablet dispersed in water were reported. ITT population included all subjects who were enrolled and received at least partial study intervention.
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End point type |
Secondary
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End point timeframe |
Day 1
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Ease of Swallowing of Tablet Dispersed in Water by the Subject as Reported by the Caregiver | ||||||||||||||||||
End point description |
An acceptability questionnaire was used to assess the ease of swallowing of tablet dispersed in water by the caregiver on the basis of reaction/ facial expression of children. Caregiver were asked to indicate how difficult/easy it was for the subjects to swallow the tablet dispersed in water on a 5-point hedonic scale: very difficult, difficult, Ok, easy, very easy. Only the category in which at least 1 subject had data were reported. Percentage of subjects with ease of swallowing of tablet dispersed in water were reported. ITT population included all subjects who were enrolled and received at least partial study intervention
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End point type |
Secondary
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End point timeframe |
Day 1
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Palatability of the Tablet Dispersed in Water Reported by the Subject | ||||||||||||||
End point description |
An acceptability questionnaire was given to subject to assess palatability of tablet dispersed in water. Subjects were asked to respond on how much they like the taste of the tablet dispersed in water on a 5-point hedonic scale: disliked very much, disliked a little, not sure, liked a little, liked a lot. Only categories with at least 1 subject are reported. ITT population included all subjects who were enrolled and received at least partial study intervention.
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End point type |
Secondary
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End point timeframe |
Day 1
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| No statistical analyses for this end point | |||||||||||||||
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End point title |
Palatability of the Tablet Dispersed in Water by the Subject as Reported by the Caregiver | ||||||||||||||||||
End point description |
An acceptability questionnaire was given to caregiver to assess palatability of tablet dispersed in water based on reaction/ facial expression of the subject. Subjects were asked to respond on how much they like the taste of the tablet dispersed in water on a 5-point hedonic scale: disliked very much, disliked a little, not sure, liked a little, liked a lot. ITT population included all subjects who were enrolled and received at least partial study intervention.
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End point type |
Secondary
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End point timeframe |
Day 1
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Ease of Dispersion of the Tablet in Water as Reported by the Caregiver | ||||||||||||||||
End point description |
Ease of dispersion of the tablet in water was reported by the caregiver. An acceptability questionnaire was given to the caregiver to assess how easy it was to disperse the tablet on a 5-point hedonic scale: very difficult, difficult, Ok, easy, very easy. Only categories with at least 1 subject are reported. ITT population included all subjects who were enrolled and received at least partial study intervention.
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End point type |
Secondary
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End point timeframe |
Day 1
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Acceptability of Taking the Tablet Dispersed in Water Everyday Reported by Subject | ||||||||||||||||||
End point description |
Acceptability of taking the tablet dispersed in water everyday by subject was reported. An acceptability questionnaire was given to subject to assess the acceptability of tablet dispersed in water. Subjects were asked to indicate how difficult/easy it was to take the tablet every day on a 5-point hedonic scale: disliked very much, disliked a little, not sure, liked a little, liked a lot. ITT population included all subjects who were enrolled and received at least partial study intervention.
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End point type |
Secondary
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End point timeframe |
Day 1
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Acceptability of Taking the Tablet Dispersed in Water Everyday by the Subject as Reported by the Caregiver | ||||||||||||||
End point description |
Acceptability of taking the tablet dispersed in water by the subject everyday was reported by the caregiver on the basis of reaction/ facial expression of children. An acceptability questionnaire was given to caregiver to assess how easy it was to give the tablet dispersed in water to child every day via a 5-point hedonic scale: very difficult, difficult, Ok, easy, very easy. Only categories with at least 1 subject are reported. ITT population included all subjects who were enrolled and received at least partial study intervention. Here N (number of subjects analysed) signifies subjects evaluable for this endpoint.
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End point type |
Secondary
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End point timeframe |
Day 1
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| No statistical analyses for this end point | |||||||||||||||
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End point title |
Percentage of Subjects With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs) | ||||||||||||
End point description |
An adverse event (AE) was any untoward medical occurrence in a clinical investigation where subjects administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. TEAEs were events between first dose of study and until 11 days after the last dose of study medication. An SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or resulted in congenital anomaly/birth defect. ITT population included all subjects who were enrolled and received at least partial study intervention.
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End point type |
Secondary
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End point timeframe |
Up to Day 11
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| No statistical analyses for this end point | |||||||||||||
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Adverse events information [1]
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Timeframe for reporting adverse events |
Up to 32 days
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Assessment type |
Non-systematic | ||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||
Dictionary version |
25.1
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Reporting groups
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Reporting group title |
DRV/COBI FDC
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Reporting group description |
Subjects received DRV 600 mg and COBI 150 mg in a FDC tablet formulation dispersed in water once orally on Day 1. | ||||||||||
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| Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||
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| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: No subject experienced non-serious adverse event during the trial. |
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
