An Overview of Cenicriviroc
October 22, 2012
Other Names: TAK-652, TBR-652
What is cenicriviroc?
Cenicriviroc is an investigational drug for the treatment of HIV infection.
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.
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.
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.
An investigational drug must be proven safe and effective in a Phase III clinical trial to be considered for traditional approval by the FDA for sale in the United States. Some drugs go through the FDA's accelerated approval process and are approved before a Phase III clinical trial is complete. After a drug is approved by the 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.
In what phase of testing is cenicriviroc?
Cenicriviroc is currently being studied in Phase II clinical trials.
What have recent studies shown about cenicriviroc?
In an early Phase II study, several different strengths of cenicriviroc taken once daily were compared to placebo in treatment-experienced HIV-infected participants. Study participants did not receive additional anti-HIV drugs as part of a background regimen. (A background regimen is a combination of drugs that are not being studied as the investigational drug[s] in the clinical trial, but are given to help control a participant's HIV infection.) In treatment-experienced adults who had not been previously treated with a CCR5 antagonist, cenicriviroc was effective in reducing viral load at all strengths. Cenicriviroc was also shown to have anti-inflammatory activity. In terms of safety, no serious side effects occurred. The most common side effects were headache, nausea, constipation, diarrhea, and sinusitis.
Additional Phase II studies of cenicriviroc in HIV treatment-naive adults are under way.
More information on Phase II testing of cenicriviroc is available from these sources:
Where can I get more information about clinical trials studying cenicriviroc?
More information about cenicriviroc-related research studies is available from the AIDSinfo database of ClinicalTrials.gov study summaries. Click on the title of any trial in the list to see the ClinicalTrials.gov trial summary and more information about the study.
I am interested in participating in a clinical trial of cenicriviroc. How can I find more information about participating in a clinical trial of an investigational drug?
Clinical trials involve benefits and risks. Before deciding to participate in a clinical trial, talk to your health care provider. For more information on participating in clinical trials, visit NIH Clinical Research Trials and You.
This article was provided by AIDSinfo. Visit the AIDSinfo website to find out more about their activities and publications.
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