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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |