Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00071097
Status:
COMPLETED
Last Update Posted:
2016-09-20
First Post:
2003-10-10
Brief Title:
TMC114-C202 A Study of Safety Efficacy and Tolerability of TMC114 and Low Dose Ritonavir in HIV-1 Infected Patients
Sponsor:
Tibotec Pharmaceuticals Ireland
Organization:
Tibotec Pharmaceuticals Ireland
Study Overview
Official Title:
A Phase II Randomized Controlled Partially Blinded Trial to Investigate Dose Response of TMC114RTV in 3-class-experienced HIV-1 Infected Patients Followed by an Open-label Period on the Recommended Dose of TMC114RTV
Status:
COMPLETED
Status Verified Date:
2016-09
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 determine the effectiveness safety and tolerability how well the body stands the drug of an investigational protease inhibitor PI called TMC114 given with low dose ritonavir
Detailed Description:
A phase II randomized controlled partially blinded trial to investigate dose response of TMC114RTV in HIV-1 infected patients who have previously received all three licensed classes of HIV antiviral drugs known as nucleoside reverse transcriptase inhibitors NRTI nonnucleoside reverse transcriptase inhibitors NNRTI and protease inhibitors PI and who are on a stable PI-containing regimen not including an NNRTI may be eligible to participate Four doses of TMC-114ritonavir will be studied 300 patients in the United States and Puerto Rico will participate The duration of the study is 96 weeks Randomize to one of 4 treatment groups TMC114RTV 400100 mg qd 800100mg qd 400100mg bid 600100 bid or control arm for 24 to 48 wks Optimal dose TMC114RTV 600100mg bid open label portion of the study The trial was extended to include 144Wks of treatment
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-C202 | None | None | None |