HIV Infection Clinical Trial
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 FTC/TDF, in HIV-1-Infected, Antiretroviral Treatment-Naïve, Adult Patients With Only CCR5-Tropic Virus
This is a single-site substudy, "Investigation of the Effect of Cenicriviroc (CVC) plus
Emtricitabine/Tenofovir (FTC/TDF) 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 FTC/TDF, 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 + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (1
tablet) QD; 2. CVC at 200mg (4 tablets, 50mg each) QD + EFV matching placebo (1 capsule) QHS
+ FTC/TDF (1 tablet) QD; 3. CVC matching placebo (4 tablets) QD + EFV 600 mg (1 capsule) QHS
+ FTC/TDF (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 (≥100,000 copies/mL versus <100,000
copies/mL) and randomized 2:2:1 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.
This is a single-site substudy, "Investigation of the Effect of Cenicriviroc (CVC) plus
Emtricitabine/Tenofovir (FTC/TDF) 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 FTC/TDF, 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 + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (1
tablet) QD; 2. CVC at 200mg (4 tablets, 50mg each) QD + EFV matching placebo (1 capsule) QHS
+ FTC/TDF (1 tablet) QD; 3. CVC matching placebo (4 tablets) QD + EFV 600 mg (1 capsule) QHS
+ FTC/TDF (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 (≥100,000 copies/mL versus <100,000
copies/mL) and randomized 2:2:1 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.
;
Observational Model: Cohort, Time Perspective: Prospective
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