drugset / Trial / NCT01281813

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

NCT01281813

Phase 3 Completed 145 enrolled Janssen Sciences Ireland UC
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2011-08-08
Primary completion
2021-07-29
Completion
2021-07-29

Drugs

EvaluationDrugModalityDoseRoute
Subject Darunavir Small molecule 200 mg Oral
Subject Darunavir Small molecule 375 mg Oral
Subject Darunavir Small molecule 600 mg Oral
Subject Darunavir Small molecule 800 mg Oral
Subject Ritonavir Other / unclassified 32 mg Oral
Subject Ritonavir Other / unclassified 100 mg Oral