Effects of Highly Active Antiretroviral Therapy on Factors Associated with Development and Control of Kaposi's Sarcoma

Patients are being recruited for a clinical trial to test the effects of highly active antiretroviral therapy on factors thought to be involved with the cause of Kaposi's sarcoma (KS) in patients with HIV infection. All patient volunteers will be tested for the presence of the virus that appears to cause KS. This virus is called the Kaposi's sarcoma-associated herpes virus (KSHV), and is also called human herpes virsus-8 (HHV-8). Patients who have KS may participate even if the KSHV virus is not detected in the blood. Patients who do not have KS must have KSHV detectable in the blood to be eligible for the study. This clinical trial involves the administration of highly active antiretroviral therapy to all patients. If you are already taking antiviral therapy, we will ask you to stop it for about 4 weeks as part of the study, and then restart it. Patient will receive up to 2 years of antiretroviral therapy while on the study. During this period, blood samples will be taken to look for any changes in immune function directed toward KSHV and for changes in other proteins in the blood that may affect KS formation. If the patient volunteer also has KS, biopsies will be taken of the lesions to study them for potential changes that may occur and that may be related to the immune system. The clinical trial does not involve experimental therapy. All treatment and diagnostic tests provided at the National Institutes of Health will be provided without charge.

For more information, please call 301.496.8959 (or 800.243.2732, extension 4).