An Overview of PRO-140
July 14, 2017
Other Names: PA14
(Compound details obtained from ChemIDplus Advanced1, NIAID Therapeutics Database2, and CytoDyn website3)
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 PRO-140?
PRO-140 is an investigational drug that is being studied for the treatment of HIV infection.
PRO-140 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.
PRO-140 works by attaching to a protein on the surface of the immune cells. The protein is called the CCR5 co-receptor. When PRO-140 attaches to the CCR5 co-receptor, certain strains of HIV -- called R5-tropic virus -- cannot attach to, enter, or infect the cell.5
Research may prove that PRO-140 is a safe and effective option for treating people with R5-tropic virus, including those for whom other entry and fusion inhibitors, such as maraviroc (brand name: Selzentry), are not working.6
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.7
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.7
Some clinical trials are categorized as "a" or "b," such as "Phase Ia" or "Phase IIb." These different subphases typically mean that a study is researching certain types of information or using a certain type of participant population.
In What Phase of Testing Is PRO-140?
PRO-140 is currently being studied in Phase IIb/III clinical trials.4,8
What Are Some Studies on PRO-140?
Study Name: NCT00642707
Purpose: The purpose of this study was to look at the effectiveness, safety, and drug properties of different doses of PRO-140 and compare PRO-140 to a placebo. (A placebo is an inactive drug that is identical in appearance to the active drug being studied.) PRO-140 was given without any other HIV medicines (also known as monotherapy) and by subcutaneous infusion. (A subcutaneous infusion is an injection placed under the skin to deliver a drug or other fluids over a period of time.)9,10
Purpose: The purpose of this study and its extension study is to evaluate whether certain individuals who already have undetectable viral loads might be able to take a planned temporary break from their daily ART by using PRO-140 as a treatment substitution to maintain viral suppression.11-13
Purpose: The purpose of this study is to look at the safety and effectiveness of using PRO-140 with a failing ART regimen for 1 week and then using PRO-140 with an optimized ART regimen for 24 weeks. (An optimized ART regimen is a combination of drugs chosen on the basis of a person's resistance test results and treatment history.) PRO 140_CD 02 Extension is designed to provide eligible participants with continued access to PRO-140.4,14
* PRO 140_CD 02 is currently recruiting participants.
Study Names: PRO 140_CD03; NCT02859961
Purpose: The purpose of this study is to evaluate the safety and effectiveness of PRO-140 monotherapy for the maintenance of viral suppression over 48 weeks.8
For more details on the studies listed above, see the Health Professional version.
This article was provided by AIDSinfo. Visit the AIDSinfo website to find out more about their activities and publications.
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