An Overview of Aldesleukin (IL-2, Proleukin)
October 30, 2016
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.
What Is Aldesleukin?
Aldesleukin is a drug that has been approved by FDA for the treatment of 2 types of cancers called renal cell carcinoma and melanoma.3
HIV infection can make a person's immune system not work properly over the course of the viral infection. When this happens:
Aldesleukin is a synthetic version of interleukin-2, which is a protein that is made naturally in the body. Interleukin-2 helps activate the immune system to make more immune cells and stimulates existing immune cells to fight infections, such as HIV infection.3,11 Researchers have studied whether aldesleukin can increase the number and survival of immune cells and boost the immune system. Aldesleukin has also been studied as part of a strategy to reduce the latent HIV reservoir.12-15
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.16
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.16 (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 Aldesleukin?
As an immune modulator for HIV infection, aldesleukin has been studied in Phase III clinical trials.4,5
What Are Some Studies On Aldesleukin?
Study Names: ANRS118; ILIADE; NCT00071890
Purpose: The purpose of this study was to see whether aldesleukin could help extend participants' time off ART and help keep participants' CD4 counts above 350 cells/mm3 during an ART treatment interruption that followed. (A treatment interruption is a planned break from HIV medicines to evaluate how well an investigational drug can maintain control of a participant's viral load during a clinical trial.)17
Study Names: ESPRIT; NCT00004978
Purpose: The purpose of this study was to evaluate whether aldesleukin plus ART could lower the risk of opportunistic infections and death in HIV-infected participants. (Opportunistic infections are infections that occur more often or are more severe in people with weakened immune systems than in people with healthy immune systems.)4,12
Study Name: SILCAAT; NCT00013611
Purpose: The purpose of this study was to evaluate whether aldesleukin plus ART could lower the risk of opportunistic infections and death in HIV-infected participants.5,12
A Phase I/II study (NCT01013415) is currently evaluating a combination HIV cure approach that uses an investigational gene therapy product plus aldesleukin.15,22
What Side Effects Might Aldesleukin Cause?
In the ANRS118 study discussed under the previous question, a high number of mild to moderate side effects associated with aldesleukin occurred in the first 24 weeks of the study. The most common side effects were weakness, fever, and nausea. Eleven participants receiving aldesleukin stopped the study early because of side effects related to aldesleukin. Overall, a low number of severe side effects occurred during the study, but they occurred more frequently in the aldesleukin group than in the ART-only group.23
Where Can I Get More Information About Clinical Trials Studying Aldesleukin?
More information about aldesleukin-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 Aldesleukin. 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.16
This article was provided by AIDSinfo. Visit the AIDSinfo website to find out more about their activities and publications.