A study to investigate if children older than 3 years and weighing at least 15 kg to less than 25 kg with HIV-1 are able to swallow a tablet containing Darunavir/Cobicistat (DRV/COBI) after it is dispersed in water.

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 12

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 <400 copies/mL within 6 months prior to or at screening.
5. Must be able to comply with the protocol requirements (willing to attempt swallowing of tablets dispersed in water, and to adhere to prohibitions and restrictions specified in this protocol).
6. 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.
7. Body weight within =15 kg to <25 kg.
8. Parent(s) (preferably both if available or as per local requirements) or their legally acceptable representative must sign an ICF indicating that they understand the purpose of, and procedures required for, the study and is/are willing to allow the child to participate in the study. Assent is also required of children capable of understanding the nature of the study (typically 7 years of age and older).
Are the trial subjects under 18? yes
Number of subjects for this age range: 12
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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