Efficacy, Safety, and Tolerability of Cenicriviroc (CVC) in Combination With Truvada or Sustiva Plus Truvada in HIV 1-infected, Antiretroviral Treatment-naïve, Adult Patients Infected With Only CCR5-tropic Virus

Completed · Phase 2

Conditions studied: HIV-1 Infection

In brief

This is a randomized, double-blind, double-dummy, 48-week, comparative study. Approximately 150 HIV-infected, treatment-naïve patients with CCR5-tropic virus will be stratified by HIV-1 RNA: ≥100,000 copies/mL versus \<100,000 copies/mL and will be randomized 2:2:1 to receive: * Arm A: CVC 100 mg (2 tablets, 50 mg each) QD + CVC matching placebo (2 tablets) QD + EFV matching placebo (1 tablet) QHS + FTC/TDF (1 tablet) QD. * Arm B: CVC 200 mg (4 tablets, 50 mg each) QD + EFV matching placebo (1 tablet) QHS + FTC/TDF (1 tablet) QD. * Arm C: CVC matching placebo (4 tablets) QD + EFV 600 mg (1 tablet) QHS + FTC/TDF (1 tablet) QD. Doses of both CVC/placebo and EFV/ placebo will be administered as double-blinded study drug. FTC/TDF will be administered as open-label study drug in a fixed-dose combination formulation (Truvada). CVC/placebo should be taken following breakfast; EFV should be taken on an empty stomach at bedtime. HIV-1 RNA levels and CD4+ and CD8+ cell counts, percentages, and ratios will be measured at every visit. Samples for viral tropism and resistance testing in case of virologic failure will be collected at Screening and each on-treatment visit. Biomarkers associated with inflammation and immune activation will be measured at Baseline (predose) and each study visit thereafter, with flow cytometry obtained at weeks 4, 12, 24, 48, and 52. Fasting metabolic indicators of glucose control (glucose and insulin for HOMA-IR, HbA1c) and fasting lipid profiles (HDL, LDL, total cholesterol, and triglycerides) will be measured at Baseline (predose) and Weeks 4, 12, 24, 48, and 52. Waist-to-hip ratios will be measured at Baseline and Weeks 24 and 48. Plasma samples will be collected and stored for possible future studies at Baseline (predose) and every visit thereafter.

Key facts

Study ID

NCT01338883

Run by

Tobira Therapeutics, Inc.

People needed

143

Starts

2011-06-01

Expected to finish

2013-06-01

Last updated by the study team

2013-07-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Southwest Center for HIV / AIDS — Phoenix, Arizona, United States
• AIDS Healthcare Foundation Research Center — Beverly Hills, California, United States
• Pacific Oaks Medical Group — Beverly Hills, California, United States
• Providence Clinical Research — Burbank, California, United States
• AIDS Research Alliance — Los Angeles, California, United States
• Peter J Ruane MD Incorporated — Los Angeles, California, United States
• Oasis Clinic — Los Angeles, California, United States
• Anthony Mills — Los Angeles, California, United States
• Orange Coast Medical Group — Newport Beach, California, United States
• Stanford University ACTU — Palo Alto, California, United States
• University of California at San Francisco — San Francisco, California, United States
• Quest Clinical Research — San Francisco, California, United States
• Georgetown University Hospital — Washington D.C., District of Columbia, United States
• Whitman-Walker Clinic — Washington D.C., District of Columbia, United States
• Therafirst Medical Center — Fort Lauderdale, Florida, United States
• Gary Richmond — Fort Lauderdale, Florida, United States
• Midway Immunology and Research Center — Ft. Pierce, Florida, United States
• University of Miami School of Medicine — Miami, Florida, United States
• Care Resource Inc. — Miami, Florida, United States
• Kinder Medical Group — Miami, Florida, United States
• Wohlfeiler, Piperato & Associates, LLC — Miami Beach, Florida, United States
• Orlando Immunology Center — Orlando, Florida, United States
• Health Positive — Safety Harbor, Florida, United States
• Treasure Coast Infectious Disease Consultants — Vero Beach, Florida, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.