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Information

An Overview of Cenicriviroc

November 17, 2017

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Other Names: CVC, TAK-652, TBR-652, cenicriviroc mesylate
Drug Class: Entry Inhibitor
Molecular Formula: C41 H52 N4 O4 S
Registry Number: 497223-25-3 (CAS)
Chemical Name: (5E)-8-[4-(2-butoxyethoxy)phenyl]-1-isobutyl-N-[4-[(S)-(3-propylimidazol-4-yl)methylsulfinyl]phenyl]-3,4-dihydro-2H-1-benzazocine-5-carboxamide
Chemical Class: Benzazepines
Company: Allergan, Takeda; Tobira Therapeutics
Phase of Development: Cenicriviroc is in Phase IIb development as a treatment for HIV.

(Compound details obtained from ChemIDplus Advanced,1 NIAID Therapeutics Database,2 Allergan press release,3 and ClinicalTrials.gov4)


What Is an Investigational Drug?

An investigational drug is one that is under study and is not approved by the U.S. Food and Drug Administration (FDA) for sale in the United States. Medical research studies are conducted to evaluate the safety and effectiveness of an investigational drug. These research studies are also called clinical trials. Once an investigational drug has been proven safe and effective in clinical trials, FDA may approve the drug for sale in the United States.

To learn more about investigational drugs, read the AIDSinfo What is an Investigational HIV Drug? fact sheet.


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What Is Cenicriviroc?

Cenicriviroc is an investigational drug that is being studied for the treatment of HIV infection and HIV-associated neurocognitive disorders (HAND). (HAND ranges from mild problems with memory, language, and reasoning to the more severe HIV-associated dementia [HAD].) Cenicriviroc is also being studied to treat 2 liver diseases called nonalcoholic steatohepatitis (NASH) and primary sclerosing cholangitis (PSC).4,5

Cenicriviroc belongs to a class (group) of HIV drugs called entry and fusion inhibitors.2 Entry and fusion inhibitors block HIV from getting into and infecting certain cells of the immune system. This prevents HIV from multiplying and can reduce the amount of HIV in the body.

Cenicriviroc works by attaching to a protein on the surface of the immune cells. The protein is called the CCR5 co-receptor. When cenicriviroc attaches to the CCR5 co-receptor, certain strains of HIV -- called R5-tropic virus -- cannot attach to, enter, or infect the cell.6

Cenicriviroc also appears to block another receptor known as CCR2. The CCR2 receptor is associated with inflammatory diseases. The potential benefits of blocking the CCR2 receptor in people with HIV are being studied.7,8


How Are Clinical Trials of Investigational Drugs Conducted?

Clinical trials are conducted in phases. Each phase has a different purpose and helps researchers answer different questions.9

  • Phase I trials: Researchers test an investigational drug in a small group of people (20-80) for the first time. The purpose is to evaluate its safety and identify side effects.
  • Phase II trials: The investigational drug is administered to a larger group of people (100-300) to determine its effectiveness and to further evaluate its safety.
  • Phase III trials: The investigational drug is administered to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it with standard or equivalent treatments, and collect information that will allow the investigational drug to be used safely.9

In most cases, an investigational drug must be proven effective and must show continued safety in a Phase III clinical trial to be considered for approval by FDA for sale in the United States. Some drugs go through FDA's accelerated approval process and are approved before a Phase III clinical trial is complete. After a drug is approved by FDA and made available to the public, researchers track its safety in Phase IV trials to seek more information about the drug's risks, benefits, and optimal use.9


In What Phase of Testing Is Cenicriviroc?

Cenicriviroc has been studied in a Phase IIb clinical trial.4


What Are Some Studies on Cenicriviroc?

Study Names: TBR-652-2-202 (Study 202); NCT01338883
Sponsor: Tobira Therapeutics, Inc.
Phase: IIb
Status: This study has been completed.
Location: United States and Puerto Rico
Participants:

  • Participants were adults with HIV who had never taken HIV medicines before. All participants had R5-tropic HIV. (R5-tropic HIV is a type of HIV that uses CCR5 as a co-receptor).
  • Participants had viral load levels of at least 1,000 copies/mL. (Viral load is the amount of HIV in a blood sample.)
  • Participants had CD4 counts of at least 200 cells/mm3. (A CD4 count is a laboratory test that measures the number of CD4 cells in a sample of blood and is an important indicator of immune function.)
Purpose: The purpose of this study was to compare the safety and effectiveness of 2 different doses of cenicriviroc versus the HIV medicine efavirenz (an FDA-approved non-nucleoside reverse transcriptase inhibitor [NNRTI]; brand name: Sustiva).4,10

Study Name: NCT02128828
Sponsor: University of Hawaii
Phase: II
Status: This study has been completed.
Location: United States
Participants:
  • Participants were adults with HIV.
  • All participants had been receiving HIV medicines for at least 1 year before the study began and all were still receiving HIV medicines at the start of the study.
  • Participants had viral loads levels of less than 50 copies/mL at the start of the study and for at least 1 year before the start of the study.
  • Participants had only mild to moderate cognitive impairment or were not cognitively impaired. (Cognitive impairment is when people have trouble remembering, learning new things, concentrating, or making decisions that affect their everyday lives.)
Purpose: The purpose of this study was to evaluate cenicriviroc's ability to improve learning, memory, and other cognitive abilities in participants with HIV.5,11

For more details on the studies listed above, see the Health Professional version of this record.

The company developing cenicriviroc is planning Phase III clinical trials to investigate a fixed-dose combination (FDC) tablet containing cenicriviroc plus the FDA-approved medicine lamivudine (brand name: Epivir).3,12

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Related Stories

Cenicriviroc Shows Good Virologic Success, Tolerability Compared to Efavirenz
More on HIV Medications
More on Entry Inhibitors in Development


  
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This article was provided by AIDSinfo. Visit the AIDSinfo website to find out more about their activities and publications.
 

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