An Overview of Cabotegravir
November 14, 2016
Other Names: 744 LA, CAB, GSK-1265744, GSK1265744, GSK744, GSK744 LA, GSK744 LAP, S-265744, S/GSK1265744, cabotegravir LA, cabotegravir sodium
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 Cabotegravir?
Cabotegravir is an investigational drug that is being studied for the treatment and prevention of HIV infection.4
Cabotegravir belongs to a class (group) of HIV drugs called integrase inhibitors.2 Integrase inhibitors block an HIV enzyme called integrase. (An enzyme is a protein that starts or increases the speed of a chemical reaction.) By blocking integrase, integrase inhibitors prevent HIV from multiplying and can reduce the amount of HIV in the body.
Cabotegravir does not require boosting with an additional drug. (Boosting involves the use of a second drug to increase the effectiveness of the main [first] drug.)5
Two forms of cabotegravir are being studied: tablets that are taken by mouth (known as oral cabotegravir or oral CAB) and a long-acting injectable form that is injected into the muscle (known as cabotegravir LA or CAB LA; LA stands for "long-acting").6,7 (A long-acting drug formulation works over a long period of time. Using this type of drug might mean that the drug could be taken less often, making a treatment or prevention regimen simpler to take.)4
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.8
In most cases, an investigational drug must be proven effective and must show continued safety in a Phase III 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.8 (Some clinical trials are categorized as "a" or "b," such as "Phase Ia" or "Phase IIb." These different sublevels 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 Cabotegravir?
Cabotegravir is currently being studied in Phase IIb testing for HIV treatment and Phase IIb/III testing for HIV prevention.2,3
What Are Some Studies on Cabotegravir?
Cabotegravir for HIV Treatment
Study Names: LAI116482 (LATTE); NCT01641809
Purpose: The purpose of this study is to find a safe and effective dose of oral cabotegravir, given as HIV maintenance therapy with the HIV oral medicine rilpivirine (brand name: Edurant). (Maintenance therapy is an ongoing treatment used to help an initial treatment succeed or to prevent a return of disease or infection.)6,9,10
Cabotegravir for HIV Prevention
Study Names: ECLAIR; NCT02076178
This article was provided by AIDSinfo. Visit the AIDSinfo website to find out more about their activities and publications.
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