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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 15
- Locations
- 6
- Primary Endpoint
- 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
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 3 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: DRV/COBI FDC (Drug)
Outcomes
Primary Outcomes
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
Time Frame: 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 Outcomes
- 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)
- Acceptability of Taking the Tablet Dispersed in Water Everyday by the Participant as Reported by the Caregiver(Day 1)
- Number of Participants with Adverse Event(Up to 32 days)
- 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)
- Acceptability of Taking the Tablet Dispersed in Water Everyday by the Participant(Day 1)
