Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00412646
Status:
COMPLETED
Last Update Posted:
2010-04-28
First Post:
2006-12-15
Brief Title:
TMC125-C203 Phase II Randomized Patients Are Assigned Different Treatments Based on Chance Placebo Controlled Dose Escalating Trial of TMC125 in HIV-1 Infected Patients
Sponsor:
Tibotec Pharmaceuticals Ireland
Organization:
Tibotec Pharmaceuticals Ireland
Study Overview
Official Title:
A Randomized Placebo-controlled Phase II Trial in HIV-1-infected NRTI- PI and NNRTI-experienced Subjects to Evaluate the Safety Tolerability and Efficacy of Different Doses of TMC125 bid on Top of an Individually Optimized Antiretroviral Therapy by Means of a 2-stage Dose-escalating Design
Status:
COMPLETED
Status Verified Date:
2010-04
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 randomized patients are assigned different treatments based on chance placebo-controlled dose-escalating trial is to evaluate the safety tolerability and efficacy of different doses of TMC125 twice daily bid when added to an individually optimized antiretroviral therapy ART for 48 weeks Dose-escalation will be performed in two stages In the first stage approximately one hundred and eighty HIV-1 positive three-class ART experienced patients will be randomized to placebo 400 or 800 mg of TMC125 bid In the second stage approximately seventy patients will be randomized to placebo 800 or 1200 mg TMC125 bid Stage 2 will be opened for enrollment after review of the available safety and efficacy data for a specified number of patients and concurrence by the Data Safety and Monitoring Board DSMB After all patients are treated for a period of 12 weeks unblinding for the sponsor will occur The trial will continue in a single-blind fashion sponsor unblinded but investigator and patient blinded for up to 48 weeks Upon completion of the initial 48 weeks of treatment patients deriving clinical benefit in the opinion of the investigator will have the option to prolong the same treatment in a single-blind setting up to a maximum of 144 weeks
Detailed Description:
Study TMC125-C203 is a phase II randomized placebo-controlled dose-escalating trial that will be conducted in 2 stages In total approximately two-hundred and fifty HIV-1 positive patients will be included in 2 stages Patients must be 3-class antiretroviral therapy ART experienced ie have previously received at least one protease inhibitor PI one nucleoside reverse transcriptase inhibitor NRTI and one non-nucleoside reverse transcriptase inhibitor NNRTI each for at least 3 months and must have a VirtualPhenotype showing sensitivity to at least 2 antiretroviral drugs used in the optimized underlying ART Stage 1 approximately 180 patients 60 patients will receive placebo 60 patients TMC125 400 mg bid and 60 patients TMC125 800 mg bid Stage 2 approximately 70 patients 10 patients will receive placebo 20 patients TMC125 800 mg bid and 40 patients TMC125 1200 mg bid Screening for study TMC125-C203 will be performed up to six weeks prior to baseline If a patient fulfills the eligibility criteria heshe will be instructed either not to change hisher current ART until the baseline visit or to continue hisher treatment interruption until baseline At the baseline visit patients will begin dosing with TMC125 and their optimized ART composed at the discretion of the investigator including at least two sensitive antiretroviral drugs as indicated by the VirtualPhenotypeTM The new optimized underlying ART started at baseline should not be changed until the end of the trial except for tolerability reasons Adverse events that begin after the start of study therapy and within 4 weeks after the last dose of study medication will be collected All adverse events still ongoing at the end of the treatment with TMC125 will be followed until satisfactory resolution or stabilization Upon completion of the initial 48-week treatment period patients deriving clinical benefit in the opinion of the investigator will have the option to prolong their treatment with a first optional 48-weeks extension period followed by a second optional 48-weeks period maximum treatment duration is 144 weeks They will continue with the dose of study medication they were assigned to at randomization in a blinded setting in addition to their optimized ART initiated during the original treatment period of this study Four weeks after 120 patients have started treatment in stage 1 all available data will be reviewed by a Data Safety and Monitoring Board DSMB Stage 2 will only be opened after concurrence by the DSMB The primary analysis will be performed once all patients in the two stages have been treated for 24 weeks or have dropped out earlier The final analysis will be performed when all patients have completed the trial up to a maximum of 144 weeks including the follow-up visits or dropped out earlier A pharmacokinetic sub-study will be performed within the framework of this trial The patients enrolled in this sub-study will have additional pharmacokinetic samples taken on top of the assessments described in this protocol to be able to generate a full pharmacokinetic profile of TMC125 and concomitantly administered PIsThe sponsor has the intention to have an open-label follow-up study available for patients who participated in this trial
Doses of placebo 400 800 and 1200 mg TMC125 as twice daily regimens have been selected for the present trial The investigational medication will be taken orally every 12 hours and within 15 minutes after breakfast and dinner for 48 weeks with optional extension periods up to a maximum of 144 weeks All other used underlying antiretroviral drugs will be taken as prescribed by the investigator
Doses of placebo 400 800 and 1200 mg TMC125 as twice daily regimens have been selected for the present trial The investigational medication will be taken orally every 12 hours and within 15 minutes after breakfast and dinner for 48 weeks with optional extension periods up to a maximum of 144 weeks All other used underlying antiretroviral drugs will be taken as prescribed by the investigator
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