Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00098293
Status:
COMPLETED
Last Update Posted:
2013-10-09
First Post:
2004-12-06
Brief Title:
Trial of Maraviroc UK-427857 in Combination With ZidovudineLamivudine Versus Efavirenz in Combination With ZidovudineLamivudine
Sponsor:
ViiV Healthcare
Organization:
ViiV Healthcare
Study Overview
Official Title:
A Multicenter Randomized Double-Blind Comparative Trial Of A Novel CCR5 Antagonist UK-427857 In Combination With ZidovudineLamivudine Versus Efavirenz In Combination With ZidovudineLamivudine For The Treatment Of Antiretroviral-Naive HIV-1 Infected Subjects
Status:
COMPLETED
Status Verified Date:
2013-08
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:
MERIT
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 goal of this study is to compare the safety and efficacy of maraviroc UK-427857 versus efavirenz when each are combined with two other antiretroviral agents in patients who are previously naive to antiretroviral therapy This study will involve approximately 200 centers from around the world to achieve a total randomized subject population of 1071 subjects Patients will be randomly assigned to one of three groups maraviroc UK-427857 300 mg once daily added to zidovudinelamivudine 300 mg150 mg twice daily Maraviroc UK-427857 300 mg twice daily added to zidovudinelamivudine 300 mg150 mg twice daily or efavirenz 600 mg once daily added to zidovudinelamivudine 300 mg150 mg twice daily The study will enroll over approximately an 18 month period 5 months Phase 2b run-in 13 months Phase 3 with 96 weeks of treatment This may be extended for an additional 3 years depending on the results at 96 weeks Physical examinations will be performed at study entry weeks 4 8 12 16 20 24 32 40 48 60 72 84 and 96 Blood samples will also be taken at study entry weeks 2 4 8 12 16 20 24 32 40 48 60 72 84 and 96 Additionally blood samples will be drawn twice at least 30 minutes apart at weeks 2 and 48 for maraviroc UK-427857 pharmacokinetic analysis As part of this clinical study a blood sample will be taken for non-anonymized pharmacogenetic analysis Patients will undergo a 12-lead electrocardiogram at study entry weeks 24 48 and 96 A computerized tomography CT scan will also be performed at selected centers at study entry and week 96 Patients will be asked to complete a symptom distress questionnaire at study entry weeks 12 24 48 and 96
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