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Continued Access to Darunavir/Ritonavir (DRV/Rtv) in HIV-1 Infected Adults, Adolescents and Children Aged 3 Years and Above (NCT03027297)

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 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).
  • Drug: Darunavir
    600 mg tablet, intake of 1 tablet twice a day in combination with ritonavir
    • Drug: Ritonavir
      100 mg capsule, to be taken once or twice daily in combination with Darunavir and following the Darunavir dosing schedule
      • Drug: Darunavir
        400 mg tablet, intake of 2 tablets once daily in combination with ritonavir
        • Drug: Ritonavir
          100 mg tablet, to be taken once or twice daily in combination with Darunavir and following the Darunavir dosing schedule
          • Drug: Darunavir
            375 mg tablet (made up of 2 x 150mg +1 x 75mg tablets), intake of 3 tablets twice a day in combination with Ritonavir
            • Drug: Darunavir
              Darunavir oral suspension (dose dependant on weight) in combination with Ritonavir
              • Drug: Ritonavir
                Ritonavir oral solution as 80 mg/mL (dose dependant on weight) in combination with Darunavir twice daily
                • Drug: Ritonavir
                  Ritonavir powder for oral suspension prepared as 100 mg/10 mL (dose dependant on weight) in combination with Darunavir
                  Ages eligible for Study
                  3 Years and older
                  Genders eligible for Study
                  All
                  Accepts Healthy Volunteers
                  No
                  Inclusion Criteria:
                  • Patients treated with DRV/rtv who have successfully completed the TMC114
                  • C211, TMC114
                  • C214, TMC114
                  • TiDP31
                  • C229 trial or the pediatric 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 (eg, 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.
                  This is a continued access trial for adult and pediatric patients who have completed treatment with darunavir in combination with low-dose ritonavir (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 DRV/rtv, and who live in a country where DRV is not accessible. At the baseline visit, inclusion and exclusion criteria will be checked to confirm eligibility. Once the eligibility criteria are met, patients will continue treatment as follows: HIV-1-infected patients participating in the TMC114-C211 trial and some HIV-1 infected patients from the pediatric trial TMC114-TiDP29-C232 will continue on the selected DRV/rtv once daily dosing regimen as administered in the original trial, or (for pediatric patients) on an adjusted dose if necessary due to a change in body weight. Some HIV-infected patients from the pediatric trial TMC114-TiDP29-C232 will continue on the selected twice daily DRV/rtv dosing regimen as administered in the original trial, or (for pediatric patients) on an adjusted dose if necessary due to a change in body weight. HIV-1-infected patients having participated in the TMC114-C214 or TMC114-TiDP31-C229 trial will continue on the DRV/rtv 600/100 mg twice daily dosing regimen as administered in the original trial. Visits and assessment are performed according to local standard of care, but desirable every 3 months for pediatric patients and not less frequently than every 6 months for adult patients. The interval between 2 consecutive visits should not exceed 6 months for pediatric patients. Adverse events (AEs) considered at least possibly related to DRV/rtv, AEs leading to discontinuation or treatment interruption, serious AEs (SAEs), and pregnancies (or all AEs if applicable per local regulation) will be recorded at each visit. Patients will be instructed to report any AEs to the investigator, who will report SAEs within 24 hours to the Sponsor. In addition to the assessments in the flowchart, the following assessments are recommended to be performed locally every 3 months or according to local, generally accepted standards of care: efficacy assessments (immunology and plasma viral load) and laboratory safety assessments (hematology and biochemistry, including pancreatic amylase [if available] or lipase and lipid analyses). Treatment will be continued until one of the following criteria is met (whichever occurs first): virologic failure; treatment-limiting toxicity; loss to follow-up; withdrawal of consent/assent by the patient; withdrawal of consent by the parent(s)/legal representative(s); pregnancy; termination of the trial by the sponsor; DRV becomes commercially available for the patients, is reimbursed, or can be accessed through another source (eg, access program, government program) in the region the patient is living in. A post-treatment follow-up contact will be performed 4 weeks after the last dose of trial medication for patients with an ongoing adverse event. This is consistent with the primary objective of the study to provide continued access to DRV/rtv for adult patients who previously received DR/rtv in the clinical trials sponsored by Tibotec Pharmaceuticals. This study is not set up to address any specific hypothesis. Depending on the previous trial the patients were in, they will continue to take either : DRV/rtv 800/100 mg once a day as 2 tablets of 400 mg DRV and 100 mg ritonavir; or DRV/rtv 600/100 mg twice a day as 1 tablet of 600 mg DRV and 100 mg ritonavir twice a day; DRV/rtv 375/100 mg twice a day as 1 tablet of 375 mg DRV and 100 mg ritonavir; DRV/rtv selected dose twice daily , or on an adjusted dose if necessary due to a change in body weight.

                  14 locations

                  Status:
                  active not recruiting
                  Type:
                  Interventional
                  Phase:
                  Start:
                  31 July, 2011
                  Updated:
                  18 January, 2017
                  Participants:
                  133
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