TMC125-TiDP35-C239 - Continued Access to Etravirine (ETR) in Treatment Experienced HIV-1 Infected Participants
Condition: HIV Infections; HIV-1
MeSH terms: HIV Infections
Intervention: Etravirine
Intervention description: Participants will be dosed with etravirine by weight up to a maximum dose of 200 mg bid until switched to an etravirine-based treatment regimens (i.e. commercially available and reimbursed, or accessible through another source) or local standard of care, as appropriate.
Intervention MeSH terms: Etravirine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 180.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: No
Keywords: TMC125-TiDP35-C239; TMC125-C239; TMC125; HIV; Etravirine; Intelence; IntelenceTM

Summary:

      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.
    

Eligibility criteria:

        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)