TMC114IFD3001 - Study Providing Continued Access to Treatment With Darunavir (DRV)/Ritonavir(Rtv) in HIV1 Infected Adults, Adolescents and Children Aged 3 Years or Above and Coming From Previous Company Sponsored Studies With DRV
Condition: HIV-1 Infections
Intervention: Darunavir; Ritonavir
Intervention description: Participants will receive darunavir (per parent study) as oral suspension.; Participants will receive ritonavir (per parent study) as oral solution/suspension.
Intervention MeSH terms: Ritonavir; Darunavir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 145.0
Sex: All
Minimum age: 3 Years
Healthy volunteers: No
Keywords: TMC114IFD3001; TMC114; HIV; Darunavir; PREZISTA

Summary:

      The primary objective of this trial is to continue the provision of darunavir/ low-dose
      ritonavir (DRV/rtv) to adult and pediatric patients who previously received DRV/rtv in the
      clinical trials TMC114-C211, TMC114-C214, TMC114-TiDP31-C229 or in the pediatric trial
      TMC114-TiDP29-C232 who continue to benefit from the use of darunavir in combination with
      low-dose ritonavir (DRV/rtv), in countries where DRV is not commercially available for the
      subject, is not reimbursed, or cannot be accessed through another source (e.g., access
      program, governmental program) and to provide DRV through this trial until the participants
      can switched to locally available DRV-based treatment regimens (that is commercially
      available and reimbursed, or accessible through another source [for example, access program
      or government program]) or to local standard of care, as appropriate.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients treated with DRV/rtv who have successfully completed the TMC114-C211,
             TMC114-C214, TMC114-TiDP31-C229 (parent) trial or the pediatric (parent) trial
             TMC114-TiDP29-C232 and in the opinion of the investigator continue to receive benefit
             from using DRV/rtv

          -  DRV is not commercially available for the patients, is not reimbursed, or cannot be
             accessed through another source (for example, access program, government program) in
             the region the patient is living in.

          -  Patients (where appropriate, depending on age) and the parent(s) or legal
             representative(s) have signed the Informed Consent/Assent Form voluntarily. Children
             will be informed about the program and asked to give assent (where appropriate,
             depending on age).

        Exclusion Criteria:

          -  Any condition (including but not limited to alcohol and drug use) which, in the
             opinion of the investigator, could compromise the patient's safety or adherence to
             treatment with DRV/rtv

          -  Any active, clinically significant disease (such as pancreas or cardiac problems) or
             findings which could compromise the patient's safety during treatment with DRV/rtv

          -  Previously demonstrated clinically significant allergy or hypersensitivity to any of
             the excipients of the investigational medication (DRV) or ritonavir

          -  Pregnant or breastfeeding female patients