An Overview of Cabotegravir
October 19, 2017
Other Names: 744 LA, CAB, GSK-1265744, GSK1265744, GSK744, GSK744 LA, GSK744 LAP, S-265744, S/GSK1265744, cabotegravir LA, cabotegravir sodium
(Compound details obtained from ChemIDplus Advanced,1 NIAID Therapeutics Database,2HIV/AIDS (Auckland, N.Z.) article, and ViiV Healthcare website4)
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 to treat and prevent HIV infection.5
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.
Unlike some integrase inhibitors, 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.)6
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").7,8 (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.)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
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 III testing for HIV treatment and prevention.2,4
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.)7,10,11
Other ongoing studies on cabotegraivr LA for HIV treatment include the FLAIR study (NCT02938520) and the ATLAS study (NCT02951052). Both are Phase III studies that are looking at the safety and effectivness of cabotegravir LA plus rilpivirine LA for maintaining viral suppression after a switch from other HIV medicines. (Viral suppression is when HIV medicines reduce a person's viral load to an undetectable level. HIV still remains in the body but in a resting, inactive state.) Both studies involve switching participants from HIV medicines that are suppressing their viral load levels to cabotegravir LA and rilpivirine LA every 4 weeks.13,14
Cabotegravir for HIV Prevention
Study Names: ECLAIR; NCT02076178
Additional studies will be evaluating cabotegravir LA for HIV prevention:
For more details on the studies listed above, see the Health Professional version of this record.
What Side Effects Might Cabotegravir Cause?
One goal of HIV research is to identify new drugs that have fewer side effects. The following side effects were observed in some of the studies of cabotegravir listed above.
Because cabotegravir is still being studied, information on possible side effects of the drug is not complete. As testing of cabotegravir continues, additional information on possible side effects will be gathered.
Where Can I Get More Information About Clinical Trials Studying Cabotegravir?
More information about cabotegravir-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.
How Can I Find More Information About Participating in a Clinical Trial?
Participating in a clinical trial can provide benefits. For example, a volunteer participant can benefit from new research treatments before they are widely available. Participants also receive regular and careful medical attention from a research team that includes doctors and other health professionals. However, clinical trials may also involve risks of varying degrees, such as unpleasant, serious, or even life-threatening side effects from the treatment being studied.9
Your health care provider can help you decide whether participating in a clinical trial is right for you. For more information, 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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