What is Aralen?

• Aralen is an anti-parasitic drug used to treat malaria. It is a generic drug manufactured widely.
   
• Aralen also exerts an effect on the immune system, reducing cellular activation and overall system inflammation. Cellular activation has been linked to faster HIV disease progression and poorer CD4 cell recovery after initiating antiretroviral (ARV) therapy. Inflammation has been linked to worsening HIV disease, and to non-HIV-related conditions that include cardiovascular disease, liver disease and certain cancers.
   
• Currently, Aralen is in early-state testing to determine its potency at reducing HIV-specific cellular activation and to potentially delay the need for a person to begin ARV therapy.

• Previous studies have confirmed the anti-inflammatory potential of Aralen, and a more recent study confirmed that it has a similar effect against HIV-specific CD8 cells.
   
• A Phase II study is currently underway comparing 12 weeks of Aralen against a placebo in HIV-positive people who have not yet started ARV therapy. The key research questions are whether Aralen is safe to use in these individuals and whether and to what degree it is able to suppress activation of CD8 cells.
   
• Like other drugs, Aralen might interact with other medications, including those used to treat HIV. It is important that your personal physician and/or the research nurse or study investigator be aware of all drugs you are taking, including those you buy without a prescription.

• Long-term use of Aralen can increase the risk of irreversible damage to the retina of the eye. People who are taking Aralen are recommended to have regular eye exams and to report any changes in eyesight to their doctors right away.
   
• Aralen can cause stomach upset, including nausea, diarrhea and cramping.
   
• Aralen can also cause skin and hair changes, including rash, sun sensitivity, hair loss and bleaching of the hair.
   
• Aralen can cause muscle weakness and nerve problems.
   
• Aralen can cause or worsen seizures.

•  People allergic to drugs that are similar to Aralen—a class of drugs called “quinalones”—should not take Aralen. Allergic reactions to Aralen can be life-threatening.
   
• Pregnant women should not use Aralen, unless they have acute malaria, as the drug can be harmful to a developing fetus.
   
• Aralen can pass into the breast milk and may have a harmful effect on an infant. Women taking Aralen are encouraged not to breast feed while taking Aralen. Also, to prevent transmission of the virus to uninfected babies, it is recommended that HIV-positive mothers not breast feed.

• If you would like to find out if you are eligible for any clinical trials that include Aralen, visit ClinicalTrials.gov, a site run by the U.S. National Institutes of Health. The site has information about all HIV-related clinical studies in the United States. For more info, you can call their toll-free number at 1-800-HIV-0440 (1-800-448-0440) or email contactus@aidsinfo.nih.gov.