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-Na´ve, 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-Na´ve, 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-na´ve 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.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
Ages Eligible For Study:
- Adult male and female, HIV-1-infected patients 18 years old and older. - Body mass index (BMI) 18 to <=35 kg/m2 - Antiretroviral treatment-naive (no prior non-nucleoside reverse transcriptase inhibitor, other than in women who received a single dose of perinatal nevirapine who have no K103 viral mutation, no prior CCR5 antagonist therapy, no more than 10 days of any other prior antiretroviral therapy) - HIV-1 CCR5-tropic-only virus, as determined on both a tropism genotype and the enhanced Trofile assay - Plasma HIV-1 RNA level >= 1,000 copies/mL at Screening Visit 1 - CD4 count >= 250 cells/mm3 at Screening Visit 1 - Able and willing to provide written informed consent - Willing to take appropriate precautions to prevent pregnancy - Women of child-bearing potential may be enrolled following a negative urine pregnancy test. If participating in activity that could lead to pregnancy, men and women must agree to use two forms of barrier method contraception during the trial and for 3 months after stopping the medication. - Women who are not of reproductive potential (documented to be surgically sterile or postmenopausal [defined as amenorrhea >= 1 year and follicle stimulating hormone>= 30 mU/mL]) are eligible to be enrolled - Signed informed consent for participation in the sub-study