Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00258557
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
2005-11-22
Brief Title:
TMC114-C211 Trial of an Investigational Protease Inhibitor TMC114 With Ritonavir TMC114r in HIV-1 Infected Patients Who Have Never Been Treated With Antiretroviral Medications
Sponsor:
Tibotec Pharmaceuticals Ireland
Organization:
Tibotec Pharmaceuticals Ireland
Study Overview
Official Title:
Phase III Randomized Controlled Open-label Trial to Investigate the Antiviral Activity Tolerability and Safety of TMC114r in Treatment- Naive HIV-1 Infected Patients
Status:
COMPLETED
Status Verified Date:
2013-06
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 compare the efficacy safety and tolerability of TMC114r versus Kaletra a combination pill of lopinavir and ritonavir lpvrtv in HIV-1 infected patients who have never been treated with anti-retroviral medications referred to as treatment-naïve patients
Detailed Description:
This is a randomized controlled open-label trial to investigate the antiviral activity tolerability and safety of TMC114r versus lpvrtv in treatment-naive HIV-1 infected patients Six hundred sixty treatment-naïve HIV-1 infected patients will be randomized in a 11 ratio to either 800100 mg of TMC114r once daily or a total daily dose of 800200 mg of lpvrtv All patients will take TMC114r or lpvrtv in combination with an NRTI background of Truvada a combination pill of tenofovir and emtricitabine TDFFTC The trial will consist of a screening period of approximately 14 to 28 days and a 96-week treatment period followed by a 4-week follow-up period The anti HIV-1 therapy initiated at baseline cannot be changed until the end of the treatment period After the end of the treatment period maximum of 96 weeks patients will be followed for an additional 4 weeks to follow-up on any adverse events or laboratory abnormalities until resolution Patients who fail either virologically or due to intolerance from the TMC114r or lpvrtv therapy as judged by the investigator or who meet one of the withdrawal criteria will be withdrawn from the trial and may have the opportunity to participate in the rollover phase of the trial
The primary efficacy parameter is virologic response defined as a confirmed viral load 50 copiesmL at Week 48 the objective of this study is to establish non-inferiority of TMC114r versus lpvrtv in terms of virologic response at Week 48 using a non-inferiority margin of 12 To test this hypothesis a two-sided 95 confidence interval CI of the difference in response rate between TMC114r and lpvrtv will be derived If the lower bound of the CI exceeds -12 non-inferiority will be concluded Patients will take oral doses for up to 96 weeks of either 800100mg of TMC114r 1xday or 800200mg of lpvrtv once daily each in combination with TDFFTC The 400100 mg 2xday dose of lpvrtv will be used where the 1xday use of lpvrtv is not approved
The primary efficacy parameter is virologic response defined as a confirmed viral load 50 copiesmL at Week 48 the objective of this study is to establish non-inferiority of TMC114r versus lpvrtv in terms of virologic response at Week 48 using a non-inferiority margin of 12 To test this hypothesis a two-sided 95 confidence interval CI of the difference in response rate between TMC114r and lpvrtv will be derived If the lower bound of the CI exceeds -12 non-inferiority will be concluded Patients will take oral doses for up to 96 weeks of either 800100mg of TMC114r 1xday or 800200mg of lpvrtv once daily each in combination with TDFFTC The 400100 mg 2xday dose of lpvrtv will be used where the 1xday use of lpvrtv is not approved
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-C211 | OTHER | Tibotec Pharmaceuticals Ireland | None |