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Last Updated: November 21, 2019

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CLINICAL TRIALS PROFILE FOR CENICRIVIROC

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Clinical Trials for Cenicriviroc

Trial ID Title Status Sponsor Phase Summary
NCT01338883 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 Tobira Therapeutics, Inc. Phase 2 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.
NCT01827540 Study of Dolutegravir (DTG) on PK of Cenicriviroc (CVC), and CVC on PK of DTG & on a Single Dose of Midazolam Completed ViiV Healthcare Phase 1 To evaluate the PK, safety and tolerability of Cenicriviroc (CVC) administered with and without Dolutegravir (DTG) and CVC with and without a single dose of Midazolam in healthy subjects.
NCT01827540 Study of Dolutegravir (DTG) on PK of Cenicriviroc (CVC), and CVC on PK of DTG & on a Single Dose of Midazolam Completed Tobira Therapeutics, Inc. Phase 1 To evaluate the PK, safety and tolerability of Cenicriviroc (CVC) administered with and without Dolutegravir (DTG) and CVC with and without a single dose of Midazolam in healthy subjects.
>Trial ID >Title >Status >Phase >Summary

Clinical Trial Conditions for Cenicriviroc

Condition Name

Condition Name for
Intervention Trials
Healthy 3
Nonalcoholic Steatohepatitis 2
Primary Sclerosing Cholangitis 1
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Condition MeSH

Condition MeSH for
Intervention Trials
Non-alcoholic Fatty Liver Disease 4
Fatty Liver 4
Liver Cirrhosis 3
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Clinical Trial Locations for Cenicriviroc

Trials by Country

Trials by Country for
Location Trials
United States 81
France 12
Australia 10
India 9
Germany 9
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Trials by US State

Trials by US State for
Location Trials
Florida 8
Arizona 4
Texas 4
California 4
New York 4
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Clinical Trial Progress for Cenicriviroc

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase Trials
Phase 3 1
Phase 2 6
Phase 1 5
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Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase Trials
Active, not recruiting 4
Completed 4
Recruiting 4
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Clinical Trial Sponsors for Cenicriviroc

Sponsor Name

Sponsor Name for
Sponsor Trials
Tobira Therapeutics, Inc. 11
Novartis Pharmaceuticals 1
Allergan 1
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Sponsor Type

Sponsor Type for
Sponsor Trials
Industry 14
Other 1
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