Ignite Creation Date:
2024-05-06 @ 12:02 AM
Last Modification Date:
2024-10-26 @ 10:43 AM
Study NCT ID:
NCT01474954
Status:
TERMINATED
Last Update Posted:
2015-05-12
First Post:
2011-11-15
Brief Title:
Investigation of The Effect of Cenicriviroc CVC Plus FTCTDF on Cardiovascular Disease Risk Factors
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
A Phase 2b Randomized Double-Blind Double-Dummy Trial of 100 or 200 mg Once-Daily Doses of Cenicriviroc CVC TBR-652 or Once-Daily EFV Each With Open-Label FTCTDF in HIV-1-Infected Antiretroviral Treatment-Naïve Adult Patients With Only CCR5-Tropic Virus
Status:
TERMINATED
Status Verified Date:
2015-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a single-site substudy Investigation of the Effect of Cenicriviroc CVC plus EmtricitabineTenofovir FTCTDF on Atherosclerosis Risk Factors open to all patients enrolled in the primary study A Phase 2b Randomized Double-Blind Double-Dummy Trial of 100 or 200 mg Once-Daily Doses of Cenicriviroc CVC TBR-652 or Once-Daily EFV Each With Open-Label FTCTDF in HIV-1-Infected Antiretroviral Treatment-Naïve Adult Patients With Only CCR5-Tropic Virus in the San Francisco Bay area to evaluate changes in brachial flow mediated dilation in patients in one of three treatment groups 1 Cenicriviroc CVC at 100mg 2 tablets 50mg each QD CVC matching placebo 2 tablets QD Efavirenz EFV matching placebo 1 capsule QHS emtricitabinetenofovir disoproxil fumarate FTCTDF 1 tablet QD 2 CVC at 200mg 4 tablets 50mg each QD EFV matching placebo 1 capsule QHS FTCTDF 1 tablet QD 3 CVC matching placebo 4 tablets QD EFV 600 mg 1 capsule QHS FTCTDF 1 tablet QD The substudy will run for the duration of the primary study 50 patients of the 150 total enrolled in the primary study will be referred to and enrolled in the cardiovascular substudy
Patients enrolled in the substudy and substudy protocol staff will be blinded to study treatment Data obtained on this substudy will be analyzed in conjunction with laboratory data for cardiovascular disease risk factors and HIV-1 RNA levels obtained on the primary study
The primary study is a randomized double-blind double-dummy 48-week comparative study in approximately 150 HIV-1-infected treatment-naïve patients with CCR5-tropic virus Patients will be stratified by Screening HIV-1 RNA level 100000 copiesmL versus 100000 copiesmL and randomized 221 to one of the three treatment groups Patients will receive all medications from the primary study and thus the primary study site will be responsible for any adverse outcomes with the drug
Patients enrolled in the substudy and substudy protocol staff will be blinded to study treatment Data obtained on this substudy will be analyzed in conjunction with laboratory data for cardiovascular disease risk factors and HIV-1 RNA levels obtained on the primary study
The primary study is a randomized double-blind double-dummy 48-week comparative study in approximately 150 HIV-1-infected treatment-naïve patients with CCR5-tropic virus Patients will be stratified by Screening HIV-1 RNA level 100000 copiesmL versus 100000 copiesmL and randomized 221 to one of the three treatment groups Patients will receive all medications from the primary study and thus the primary study site will be responsible for any adverse outcomes with the drug
Detailed Description:
This is a single-site substudy Investigation of the Effect of Cenicriviroc CVC plus EmtricitabineTenofovir FTCTDF on Atherosclerosis Risk Factors open to all patients enrolled in the primary study A Phase 2b Randomized Double-Blind Double-Dummy Trial of 100 or 200 mg Once-Daily Doses of Cenicriviroc CVC TBR-652 or Once-Daily EFV Each With Open-Label FTCTDF in HIV-1-Infected Antiretroviral Treatment-Naïve Adult Patients With Only CCR5-Tropic Virus in the San Francisco Bay area to evaluate changes in brachial flow mediated dilation in patients in one of three treatment groups 1 Cenicriviroc CVC at 100mg 2 tablets 50mg each QD CVC matching placebo 2 tablets QD Efavirenz EFV matching placebo 1 capsule QHS emtricitabinetenofovir disoproxil fumarate FTCTDF 1 tablet QD 2 CVC at 200mg 4 tablets 50mg each QD EFV matching placebo 1 capsule QHS FTCTDF 1 tablet QD 3 CVC matching placebo 4 tablets QD EFV 600 mg 1 capsule QHS FTCTDF 1 tablet QD The substudy will run for the duration of the primary study 50 patients of the 150 total enrolled in the primary study will be referred to and enrolled in the cardiovascular substudy
Patients enrolled in the substudy and substudy protocol staff will be blinded to study treatment Data obtained on this substudy will be analyzed in conjunction with laboratory data for cardiovascular disease risk factors and HIV-1 RNA levels obtained on the primary study
The primary study is a randomized double-blind double-dummy 48-week comparative study in approximately 150 HIV-1-infected treatment-naïve patients with CCR5-tropic virus Patients will be stratified by Screening HIV-1 RNA level 100000 copiesmL versus 100000 copiesmL and randomized 221 to one of the three treatment groups Patients will receive all medications from the primary study and thus the primary study site will be responsible for any adverse outcomes with the drug
Primary Objective
To assess changes from Baseline in brachial artery vascular patency after 24 weeks of treatment with a CVC containing regimen
Secondary Objectives
To compare changes from Baseline in vascular patency and after 48 weeks of treatment with CVC versus EFV
To assess changes from Baseline to Weeks 4 12 24 and final follow-up in vascular patency
To assess changes from Baseline to Week 48 in flow-mediated dilation FMD in relation to immunologic and metabolic covariates
Patients enrolled in the substudy and substudy protocol staff will be blinded to study treatment Data obtained on this substudy will be analyzed in conjunction with laboratory data for cardiovascular disease risk factors and HIV-1 RNA levels obtained on the primary study
The primary study is a randomized double-blind double-dummy 48-week comparative study in approximately 150 HIV-1-infected treatment-naïve patients with CCR5-tropic virus Patients will be stratified by Screening HIV-1 RNA level 100000 copiesmL versus 100000 copiesmL and randomized 221 to one of the three treatment groups Patients will receive all medications from the primary study and thus the primary study site will be responsible for any adverse outcomes with the drug
Primary Objective
To assess changes from Baseline in brachial artery vascular patency after 24 weeks of treatment with a CVC containing regimen
Secondary Objectives
To compare changes from Baseline in vascular patency and after 48 weeks of treatment with CVC versus EFV
To assess changes from Baseline to Weeks 4 12 24 and final follow-up in vascular patency
To assess changes from Baseline to Week 48 in flow-mediated dilation FMD in relation to immunologic and metabolic covariates
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