Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00115050
Status:
COMPLETED
Last Update Posted:
2011-06-10
First Post:
2005-06-20
Brief Title:
TMC114-C209 A Study of Safety of TMC114 With Low Dose Ritonavir RTV and Other Antiretrovirals in Experienced HIV-1 Infected Patients With Limited or no Treatment Options
Sponsor:
Tibotec Pharmaceuticals Ireland
Organization:
Tibotec Pharmaceuticals Ireland
Study Overview
Official Title:
Open-label Safety Study of TMC114 in Combination With Low Dose RTV and Other ARVs in Highly Experienced HIV-1 Infected Patients With Limited or no Treatment Options
Status:
COMPLETED
Status Verified Date:
2011-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open-label safety study to provide early access to TMC114 for HIV-1 infected patients who have failed and exhausted regimens based on commercially available antiretroviral ARV therapy and who are ineligible for participation in any other Tibotec-sponsored trial
Detailed Description:
This is an open-label non-randomized safety study to provide early access to TMC114 for HIV-1 infected patients who have failed and exhausted regimens based on commercially available antiretroviral ARV therapy and who are ineligible for participation in any other Tibotec-sponsored trial The safety and tolerability of TMC114 in combination with low dose ritonavir RTV and other ARVs in highly ARV-experienced HIV-1 infected patients with limited or no treatment options will be assessed Treatment will be continued until treatment-limiting toxicity lost to follow-up withdrawal pregnancy discontinuation of TMC114 development or when TMC114 is commercially available to the patient Total daily dose is 600 mg TMC114 twice daily each intake in combination with one capsule of 100 mg Ritonavir Since TMC114 is formulated as 300mg tablets F014 this means 2X2 tablets per day taken orally Treatment will be continued until treatment-limiting toxicity lost to follow-up withdrawal pregnancy discontinuation of TMC114 development or when TMC114 is commercially available to the patient
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None