TMC114-C211: Trial of an Investigational Protease Inhibitor TMC114 With Ritonavir ("TMC114/r") in HIV-1 Infected Patients Who Have Never Been Treated With Antiretroviral Medications.
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00258557 |
Recruitment Status
:
Completed
First Posted
: November 24, 2005
Last Update Posted
: June 26, 2013
|
Tracking Information | ||||
---|---|---|---|---|
First Submitted Date ICMJE | November 22, 2005 | |||
First Posted Date ICMJE | November 24, 2005 | |||
Last Update Posted Date | June 26, 2013 | |||
Study Start Date ICMJE | September 2005 | |||
Actual Primary Completion Date | June 2007 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Confirmed Virologic Response defined as a Viral Load < 50 copies/mL at Week 48 [ Time Frame: 48 weeks ] | |||
Original Primary Outcome Measures ICMJE |
Confirmed Virologic Response defined as a Viral Load < 50 copies/mL at Week 48 | |||
Change History | Complete list of historical versions of study NCT00258557 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
Evaluation of safety, tolerability, and durability of efficacy over 96 weeks of treatment [ Time Frame: 192 weeks ] | |||
Original Secondary Outcome Measures ICMJE |
Evaluation of safety, tolerability, and durability of efficacy over 96 weeks of treatment | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | TMC114-C211: Trial of an Investigational Protease Inhibitor TMC114 With Ritonavir ("TMC114/r") in HIV-1 Infected Patients Who Have Never Been Treated With Antiretroviral Medications. | |||
Official Title ICMJE | Phase III Randomized, Controlled, Open-label Trial to Investigate the Antiviral Activity, Tolerability and Safety of TMC114/r in Treatment- Naive HIV-1 Infected Patients. | |||
Brief Summary | The purpose of this study is to compare the efficacy, safety and tolerability of TMC114/r versus Kaletra (a combination pill of lopinavir and ritonavir, ("lpv/rtv") 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 TMC114/r) versus lpv/rtv in treatment-naive HIV-1 infected patients. Six hundred sixty treatment-naïve HIV-1 infected patients will be randomized in a 1:1 ratio to either 800/100 mg of TMC114/r once daily, or a total daily dose of 800/200 mg of lpv/rtv. All patients will take TMC114/r or lpv/rtv in combination with an NRTI background of Truvada (a combination pill of tenofovir and emtricitabine, "TDF/FTC"). 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 TMC114/r or lpv/rtv 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 copies/mL at Week 48 the objective of this study is to establish non-inferiority of TMC114/r versus lpv/rtv 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 TMC114/r and lpv/rtv 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 800/100mg of TMC114/r 1x/day or 800/200mg of lpv/rtv once daily, each in combination with TDF/FTC. (The 400/100 mg 2x/day dose of lpv/rtv will be used where the 1x/day use of lpv/rtv is not approved). |
|||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
|||
Condition ICMJE | HIV | |||
Intervention ICMJE |
|
|||
Study Arms |
|
|||
Publications * |
|
|||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
692 | |||
Original Enrollment ICMJE |
660 | |||
Actual Study Completion Date | May 2012 | |||
Actual Primary Completion Date | June 2007 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
|||
Sex/Gender |
|
|||
Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Argentina, Australia, Austria, Belgium, Canada, Chile, Costa Rica, Denmark, France, Germany, Greece, Guatemala, Malaysia, Mexico, Panama, Puerto Rico, Russian Federation, Singapore, South Africa, Spain, Switzerland, Taiwan, Thailand, United Kingdom, United States | |||
Removed Location Countries | Brazil, Hungary, Italy, Netherlands, Peru, Poland, Portugal, Uganda, Venezuela | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00258557 | |||
Other Study ID Numbers ICMJE | CR002800 TMC114-C211 ( Other Identifier: Tibotec Pharmaceuticals, Ireland ) |
|||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Tibotec Pharmaceuticals, Ireland | |||
Study Sponsor ICMJE | Tibotec Pharmaceuticals, Ireland | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
|
|||
PRS Account | Tibotec Pharmaceuticals, Ireland | |||
Verification Date | June 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |