Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | PHASE3 | COMPLETED | 145 | — | — | Aug 8, 2011 | Jul 29, 2021 | Oct 31, 2022 | 17 | Brazil, Costa Rica +6 |
| NCT01138605 | TMC114-TiDP29-C232 - Study Providing Continued Access to Treatment With Darunavir (DRV)/Ritonavir (Rtv) for Children Coming From Any of the Three Ongoing Tibotec Sponsored Pediatric Studies With DRV | PHASE2 | COMPLETED | 46 | — | — | Oct 13, 2010 | Nov 23, 2017 | May 1, 2019 | 13 | Argentina, Brazil +6 |
Adverse events (AEs): any untoward medical occurrence (any unfavorable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease) that occurred in a participant administered a pharmaceutical product and which did not necessarily have causal relationship with study treatment. Serious adverse events (SAEs): any untoward medical occurrence at any dose resulted: death; was life threatening; requires inpatient hospitalization/prolongation of existing hospitalization; resulted in persistent/significant disability/incapacity or congenital anomaly/birth defect. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study were included in single arm and combined analysis was performed as planned in protocol because the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
Adverse events (AEs) were defined as any untoward medical occurrence (any unfavorable and unintended sign \[including an abnormal laboratory finding\], symptom, or disease) that occurred in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study were included in single arm and combined analysis was performed as planned in protocol because the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
Number of participants with adverse events possibly related to DRV/rtv treatment were reported. Adult participants who received either DRV/rtv 800/100 mg once daily or DRV/rtv 600/100 mg twice daily per parent study were included in single arm and combined analysis was performed as planned in protocol because the 2 doses were extensively evaluated in their respective parent studies. Main purpose of this study was to provide continued access and not to compare the 2 doses.
| Arm | Type | Description |
|---|---|---|
| Continued Treatment with DRV in Combination with rtv | EXPERIMENTAL | HIV-1 infected children participants (aged less than \[\<\] 12 years) will continue to receive darunavir (DRV) 200 to 600 milligrams (mg) as oral suspension twice daily (BID) along with ritonavir (rtv) 32 to 100 mg as oral solution/suspension BID. HIV-1 infected adolescent participants (aged 12-17 years) will continue to receive DRV 200 to 600 mg as oral suspension BID along with rtv 32 to 100 mg as oral solution/suspension BID. Dosing for children and adolescent participants will be based on body weight (per parent study TMC114-TiDP29-C232). HIV-1 infected adult participants (aged greater than or equal to \[\>=\] 18 years) will continue to receive DRV 800 mg (2 tablets of 400 mg) orally every day (qd) along with rtv 100 mg tablet (per parent study TMC114-C211) or DRV 600 mg tablet orally BID along with rtv 100 mg tablet (per parent study TMC114-C214 or TMC114-TiDP31-C229). |
| 005 | EXPERIMENTAL | Darunavir 400 mg tablet intake of 2 tablets once daily in combination with ritonavir |
| 006 | EXPERIMENTAL | Ritonavir Liquid formulation 80 mg/ml taken in combination with Darunavir |
| 007 | EXPERIMENTAL | Ritonavir 100 mg capsule to be taken once or twice daily in combination with Darunavir and following the Darunavir dosing schedule |
| 008 | EXPERIMENTAL | Ritonavir 100 mg tablet to be taken once or twice daily in combination with Darunavir and following the Darunavir dosing schedule |
| 001 | EXPERIMENTAL | Darunavir Oral suspension 100 mg/ml 20 mg/kg twice daily in combination with ritonavir for body weight between 10 and 20 kg |
| 002 | EXPERIMENTAL | Darunavir 375 mg composed via oral solution or various tablets twice daily in combination with ritonavir for body weight between 20 and 30 kg |
| 003 | EXPERIMENTAL | Darunavir 450 mg composed via oral solution or various tablets twice daily in combination with ritonavir for body weight between 30 and 40 kg |
| 004 | EXPERIMENTAL | Darunavir 600mg composed via oral solution or various tablets twice daily in combination with ritonavir for body weight as of 40 kg |
| 009 | EXPERIMENTAL | Ritonavir powder for oral suspension 10 mg/mL taken in combination with Darunavir. |
| Name | Type | Description |
|---|---|---|
| Darunavir | DRUG | Participants will receive darunavir (per parent study) as oral suspension. |
| Ritonavir | DRUG | Participants will receive ritonavir (per parent study) as oral solution/suspension. |
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 c...