Clinical trial NCT05197075: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Human Immunodeficiency Virus (HIV)
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2022-01-19
Enrollment: 15
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: 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
timeFrame: Day 1
Secondary outcomes:
measure: Ease of Swallowing of Tablet Dispersed in Water by the Participant
timeFrame: Day 1
measure: Ease of Swallowing of Tablet Dispersed in Water by the Participant as Reported by the Caregiver
timeFrame: Day 1
measure: Palatability of the Tablet Dispersed in Water by the Participant
timeFrame: Day 1
measure: Palatability of the Tablet Dispersed in Water by the Participant as Reported by the Caregiver
timeFrame: Day 1
measure: Ease of Dispersion of the Tablet in the Water as Reported by the Caregiver
timeFrame: Day 1
measure: Acceptability of Taking the Tablet Dispersed in Water Everyday by the Participant
timeFrame: Day 1
measure: Acceptability of Taking the Tablet Dispersed in Water Everyday by the Participant as Reported by the Caregiver
timeFrame: Day 1
measure: Number of Participants with Adverse Event
timeFrame: Up to 32 days
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Johannesburg
country: South Africa
facility: Rahima Moosa Mother and Child Hospital, University of Witwatersrand
city: Pretoria
country: South Africa
facility: Global Clinical Trials PE
city: Madrid
country: Spain
facility: Hosp. Gral. Univ. Gregorio Maranon
city: Madrid
country: Spain
facility: Hosp. Clinico San Carlos
city: Madrid
country: Spain
facility: Hosp. Univ. La Paz
Study officials:
affiliation: Janssen Research and Development LLC
name: Janssen Research and Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: