Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00110877
Status:
COMPLETED
Last Update Posted:
2015-07-03
First Post:
2005-05-13
Brief Title:
TMC114-C214 Trial of TMC114 Administered With Low Dose Ritonavir RTV in HIV-1 Infected Treatment Experienced Patients
Sponsor:
Tibotec Pharmaceuticals Ireland
Organization:
Tibotec Pharmaceuticals Ireland
Study Overview
Official Title:
A Randomized Controlled Open-label Trial to Compare the Efficacy Safety and Tolerability of TMC114RTV Versus LPVRTV in Treatment-Experienced HIV-1 Infected Patients
Status:
COMPLETED
Status Verified Date:
2015-07
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:
Study TMC114-C214 is a randomized controlled open-label trial to compare the efficacy safety and tolerability of TMC114 boosted with low dose ritonavir RTV versus Kaletra LPVRTV in lopinavir-naïve treatment-experienced HIV-1 infected patients
Detailed Description:
Study TMC114-C214 is a randomized patients are assigned to different treatment groups based on chance controlled open-label trial to compare the efficacy effectiveness safety and tolerability of TMC114 boosted with low dose ritonavir RTV versus Kaletra LPVRTV in treatment-experienced HIV-1 infected patients This research study will look at the safety of TMC114 and effectiveness in reducing the amount of HIVviral load in the blood People included in this study will have received either Non-Nucleoside Reverse Transcriptase Inhibitors NNRTIs or Protease Inhibitors PIs or both The duration of the study will be approximately 106 weeks which includes a 4 to 6 week screening period 96-week treatment period and 4-week follow-up period TMC114 300mg are orange tablets where 2 tablets are taken by mouth twice a day with 1 tablet of Ritonavir Kaletra LPVRTV is either a tablet or capsule taken twice a day The oral capsule contains 1333 mg LPV 333 mg RTV and the film-coated tablet is available for oral administration in a strength of 200 mg of lopinavir and 50 mg of ritonavir Dosing for all medication will occur for 96 weeks and you will be randomly assigned to either TMC114 or Kaletra
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 |
|---|---|---|---|
| TMC114-C214 | OTHER | Tibotec Pharmaceuticals Ireland | None |