An Overview of Cenicriviroc
October 13, 2016
Other Names: CVC, TAK-652, TBR-652, cenicriviroc mesylate
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.
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).3-5
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
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.2,3
What Are Some Studies on Cenicriviroc?
Study Name: TBR-652-2-202 (Study 202); NCT01338883
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).3,10
For more details on this study, see the Health Professional version.
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).11
This article was provided by AIDSinfo. Visit the AIDSinfo website to find out more about their activities and publications.
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