Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00354627
Status:
COMPLETED
Last Update Posted:
2015-06-12
First Post:
2006-07-18
Brief Title:
The TMC125-C214 Study Provides Early Access to TMC125 for HIV-1 Infected Patients Who Have Failed Multiple Antiretroviral Regimens and Will Also Gather Information on the Long-term Safety and Tolerability of TMC125 Combined With Other Antiretroviral Drugs
Sponsor:
Tibotec Pharmaceuticals Ireland
Organization:
Tibotec Pharmaceuticals Ireland
Study Overview
Official Title:
Early Access of TMC125 in Combination With Other Antiretrovirals in Treatment-experienced HIV-1 Infected Subjects With Limited Treatment Options
Status:
COMPLETED
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to provide early access of TMC125 to HIV-1 infected patients who have failed multiple antiretroviral ARV regimens Information on safety and tolerability aspects of TMC125 in combination with other ARVs in treatment-experienced HIV-1 patients with limited treatment options will be assessed Available data regarding the effectiveness of the drug will also be collected To be eligible patients should be failing their current ARV regimen or be on a treatment interruption should have previously received 2 different protease inhibitor PI containing regimens and be at least 3-class experienced protease inhibitors PI nucleosidetide reverse transcriptase inhibitors NtRTIs and non-nucleoside reverse transcriptase inhibitors NNRTIs or at least 2-class experienced PIs and NtRTIs with primary NNRTI resistance TMC125 will be administered in combination with an investigator-selected background of additional ARVs from the list of allowed medications
Detailed Description:
This is an open label trial with primary objective to provide early access to TMC125 for treatment-experienced HIV-1 infected patients who have failed multiple antiretroviral ARV regimens and have limited treatment options with currently approved ARVs The secondary objective of this trial is to gather information on the safety and tolerability aspects of TMC125 in combination with other ARVs Available efficacy data will also be collected Patients should be at least 3-class experienced or 2-class experienced with primary non-nucleoside reverse transcriptase inhibitor NNRTI resistance They should also have previously received 2 different protease inhibitor-based regimens low-dose ritonavir is not counted as a protease inhibitor PI regimen be on a treatment interruption or not be virologically suppressed on their current regimen and not be able to use currently approved NNRTIs due to resistance primary or acquired andor intolerance Patients must also meet all in- and exclusion criteria TMC125 200mg twice daily will be provided once the patient has been confirmed eligible for entry Once treatment with TMC125 in combination with other ARVs has been initiated patients must be instructed to follow the recommended visit schedule based on routine clinical care Safety and tolerability of the entire antiretroviral therapy ART regimen including TMC125 should be monitored by the investigator as per standard clinical practice However it is recommended that visits be planned 4 and 12 weeks following initiation of TMC125 in combination with other ARVs and every 12 weeks thereafter while on therapy during this trial Adverse events AEs leading to treatment interruption or discontinuation and all serious adverse events SAEs with the exception of Acquired Immunodeficiency Syndrome AIDS defining illnesses CDC class C unless fatal or considered to be related to TMC125 will be collected Other adverse events will be collected only if required as per local regulations The background ARVs may be changed at any time during the trial at the discretion of the investigator due to the development of resistance intolerance toxicity etc while continuing treatment with TMC125 if in the investigators assessment the patient still benefits from treatment with TMC125 If changes in the background regimen are made it is recommended that a follow-up visit be planned 4 weeks after the change in therapy Treatment with investigational medication will be continued until virologic failure treatment-limiting toxicity subject lost to follow-up patients withdrawal pregnancy discontinuation of TMC125 development or when TMC125 has become commercially available in the patients country Patients will be instructed to orally take two 100 mg tablets of TMC125 following a meal every 12 hours TMC125 200 mg twice daily must be used in combination with other antiretroviral drugs Treatment with investigational medication will continue until virologic failure treatment-limiting toxicity patient lost to follow-up withdrawal pregnancy discontinuation of TMC125 development or when TMC125 becomes commercially available in the patients country
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| TMC125-C214 | OTHER | Tibotec Pharmaceuticals Ireland | None |