Human Immunodeficiency Virus-1 MedDRA version: 20.1 Level: LLT Classification code 10020443 Term: Human immunodeficiency virus syndrome System Organ Class: 100000004862
Conditions
Sponsors
Janssen-Cilag International NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Each potential participant must satisfy all of the following criteria to be enrolled in the study: 1. 3 years or older. 2. Has documented chronic HIV-1 infection. 3. Must be on an allowed stable unchanged ARV regimen for at least 3 months prior to screening. 4. Has a documented plasma HIV-1 RNA =65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: Any potential participant who meets any of the following criteria will be excluded from participating in the study: 1. Known allergies, hypersensitivity, or intolerance to DRV/COBI or any excipient of the study intervention. 2. Has taken any disallowed therapies. 3. Any active condition (eg, 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 (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments and outcomes. 4. Active acquired immunodeficiency syndrome (AIDS)-defining illness at screening. 5. Has had any contact with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) positive or Coronavirus Disease 2019 (COVID-19) patients within the last 2 weeks prior to admission to the clinical research center. 6. Participant is a family member of an employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, or is a family member of an employee of Johnson & Johnson.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess, as part of the acceptability, the ability to swallow the 600/90 mg DRV/COBI FDC tablet dispersed in water;Primary end point(s): Ability to take the 600/90 mg DRV/COBI FDC tablet dispersed in water, derived from a questionnaire to be completed by the observing site personnel;Timepoint(s) of evaluation of this end point: Day 1;Secondary Objective: - To assess, as part of acceptability, the ease of swallowing, the palatability, and the ease of dispersion of the 600/90 mg DRV/COBI FDC tablet dispersed in water - To assess the acceptability of the intake of the 600/90 mg DRV/COBI FDC tablet dispersed in water, if to be taken daily - To evaluate short-term safety and tolerability of the 600/90 mg DRV/COBI FDC tablet dispersed in water | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Day 1 through Day 11;Secondary end point(s): For the 600/90 mg DRV/COBI FDC tablet dispersed in water: - Ease of swallowing, assessed using a questionnaire to be completed by the participant and a questionnaire to be completed by the caregiver - Palatability assessed using a questionnaire to be completed by the participant and a questionnaire to be completed by the caregiver - Ease of dispersion assessed using a questionnaire to be completed by the caregiver - Acceptability, if to be taken daily, using a questionnaire to be completed by the participant and a questionnaire to be completed by the caregiver - Assessment of adverse events | — |
Countries
South Africa, Spain, United States
Contacts
Public ContactGlobal Clinical Operations Spain
Janssen-Cilag, S.A.
Outcome results
None listed