Continued Access to Etravirine (ETR) in Treatment Experienced HIV-1 Infected Subjects

CR016408

The purpose of this study is to provide etravirine (ETR) through this trial until participants can be switched to locally available ETR-based treatment regimens (that is, commercially available and reimbursed, or accessible through another source \[example, access program or government program\]), or local standard of care, as appropriate.

2009-12-01

2020-11-01

2032-01-01

Active (not recruiting)

Early phase I

180

Inclusion Criteria: * Participants who meet all of the following criteria are eligible for this trial: Documented HIV-1 infection * Male or female participants, aged 2 years and older * Successfully completed a clinical (parent) pediatric trial with ETR sponsored by or in collaboration with Janssen Research \& Development, and continues to receive benefit from the use of ETR * Participant (where appropriate, depending on age) and their parent(s) or legal representative(s) have signed the Informed Consent Form (ICF)/Assent voluntarily * Children will be informed about the program and asked to give assent (where appropriate, depending on age) * Negative urine pregnancy test for females of childbearing potential Exclusion Criteria: * Participants meeting one or more of the following criteria cannot be selected: Any condition (including but not limited to alcohol and drug use), which in the opinion of the investigator could compromise the participant's safety or adherence to treatment with ETR * Any active clinically significant disease (e.g., pancreatitis, cardiac dysfunction) or findings of medical history, laboratory or physical examination that, in the investigator's opinion, would compromise the participant's safety during treatment with ETR * Previously demonstrated clinically significant allergy or hypersensitivity to ETR or to any of the excipients of ETR * Pregnant or breastfeeding * Non-vasectomized heterosexually active boys not using safe and effective birth control methods, or not willing to continue practicing these birth control methods, during the trial and until 30 days after the end of the trial (or after the last intake of the investigational medication) * Girls, who are sexually active and able to become pregnant, not using safe and effective birth control methods, or not willing to continue practicing these birth control methods, during the trial and until 30 days after the end of the trial (or after the last intake of the investigational medication)

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 180, 'type': 'ACTUAL'}}

2024-05-24