Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00098722
Status:
COMPLETED
Last Update Posted:
2012-05-16
First Post:
2004-12-07
Brief Title:
Trial of Maraviroc UK-427857 in Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone for the Treatment of HIV-1 Infected Subjects
Sponsor:
ViiV Healthcare
Organization:
ViiV Healthcare
Study Overview
Official Title:
A Multicenter Randomized Double-Blind Placebo-Controlled Trial of a Novel CCR5 Antagonist UK-427857 in Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone for the Treatment of Antiretroviral-Experienced HIV-1 Infected Subjects
Status:
COMPLETED
Status Verified Date:
2012-04
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:
MOTIVATE 2
Brief Summary:
Maraviroc UK-427857 a selective and reversible CCR5 coreceptor antagonist has been shown to be active in vitro against a wide range of clinical isolates including those resistant to existing classes In HIV-1 infected patients maraviroc UK-427857 given as monotherapy for 10 days reduced HIV-1 viral load by up to 16 log consistent with currently available agents Safety and toleration have been studied in over 400 subjects for up to 28 days at 300 mg twice daily No significant effects were seen on the QTc interval The purpose of this study is to evaluate the antiretroviral activity of maraviroc UK-427857 in HIV infected treatment experienced patients who are failing their current antiretroviral regimen and infected with R5-tropic virus exclusively This study will involve more than 100 centers in Europe and Australia to achieve a total randomized subject population of 500 subjects Patients will be randomly 221 assigned to one of three groups Optimized Background Therapy OBT 3-6 drugs based on treatment history and resistance testing maraviroc UK-427857 150 mg taken once daily OBT maraviroc UK-427857 150 mg taken twice daily or OBT alone The study will enroll over approximately a 9 month period with 48 weeks of treatment This may be extended for an additional year depending on the results at 48 weeks Physical examinations will be performed at study entry weeks 4 8 12 16 20 24 32 40 and 48 Blood samples will also be taken at study entry weeks 2 4 8 12 16 20 24 32 40 and 48 Additionally blood samples will be drawn twice at least 30 minutes apart at weeks 2 and 24 for maraviroc UK-427857 pharmacokinetic analysis As part of this clinical study a blood sample will also be taken for non-anonymized pharmacogenetic analysis Patients will undergo a 12-lead electrocardiogram at study entry weeks 24 and 48
Detailed Description:
None
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