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
- Conditions
- Human Immunodeficiency Virus (HIV)
- Interventions
- Drug: DRV/COBI FDC
- Registration Number
- NCT05197075
- Lead Sponsor
- Janssen Research & Development, LLC
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Darunavir/Cobicistat (DRV/COBI) Fixed Dose Combination (FDC) DRV/COBI FDC Participants will receive the DRV/COBI FDC tablet for oral use, dispersed in water on Day 1.
- Primary Outcome Measures
Name Time Method 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 Day 1 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
Name Time Method Ease of Swallowing of Tablet Dispersed in Water by the Participant Day 1 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 Day 1 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 Day 1 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).
Acceptability of Taking the Tablet Dispersed in Water Everyday by the Participant as Reported by the Caregiver Day 1 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 Up to 32 days 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.
Palatability of the Tablet Dispersed in Water by the Participant as Reported by the Caregiver Day 1 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 Day 1 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 Day 1 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).
Trial Locations
- Locations (6)
Hosp. Gral. Univ. Gregorio Maranon
🇪🇸Madrid, Spain
Global Clinical Trials PE
🇿🇦Pretoria, South Africa
Emory University
🇺🇸Atlanta, Georgia, United States
Rahima Moosa Mother and Child Hospital, University of Witwatersrand
🇿🇦Johannesburg, South Africa
Hosp. Univ. La Paz
🇪🇸Madrid, Spain
Hosp. Clinico San Carlos
🇪🇸Madrid, Spain