Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 8:02 PM
Ignite Modification Date:
2025-12-24 @ 8:02 PM
NCT ID:
NCT04006704
Eligibility Criteria:
Inclusion Criteria:
* Have a body weight of at least 25 kilogram (kg) and less than (\<) 40 kg
* Has documented chronic human immunodeficiency virus type 1 (HIV-1) infection
* Must be on a stable antiretroviral (ARV) regimen for at least 3 months prior to screening
* Has documented plasma HIV-1 ribonucleic acid (RNA) \< 400 copies/milliliter (mL) within 6 months prior to screening
* Parent(s) or their legally acceptable representative must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is 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)
Exclusion Criteria:
* 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, or limit or confound the protocol-specified assessments and outcomes or for which, in the opinion of the investigator, participation could compromise the safety or well-being of the participant
* Taking any disallowed therapies
* Is a family member of an employee or investigator of the 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
* Have any known allergies to the excipients of the placebo tablet
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
11 Years
Study:
NCT04006704
Study Brief:
Protocol Section:
NCT04006704