Antiviral Therapy in Treating Patients Who Have or Are at Risk of Developing Kaposi's Sarcoma Related to HIV

2014-08-27 03:56:46 | BioPortfolio


RATIONALE: Herpesvirus is found in many Kaposi's sarcoma lesions. Antiviral drugs act against many types of herpes viruses and may be an effective treatment for Kaposi's sarcoma.

PURPOSE: Phase II trial to study the effectiveness of combining antiviral drugs in treating patients with HIV who have or are at risk of developing Kaposi's sarcoma.



- Determine the effects of potent antiretroviral therapy on specific factors potentially linked to the control or pathogenesis of Kaposi's sarcoma (KS), such as serum viral interleukin-6 and plasma vascular endothelial growth factor levels, in patients with KS or who are at risk for KS by virtue of being infected with KS-associated herpes virus/human herpes virus-8 (KSHV/HHV-8).

- Determine the effect of the initiation of antiretroviral therapy on the KSHV/HHV-8 load in patients who are coinfected with KSHV/HHV-8 and HIV.

- Determine the effect of antiretroviral therapy on other parameters believed to be involved in the pathogenesis of KS, including interleukin-8, cellular interleukin-6, serum-inducible protein 10, and basic fibroblast growth factor, in these patients.

- Determine the KS response in patients treated with highly active antiretroviral therapy.

OUTLINE: Patients are stratified according to disease status (diagnosis of KS vs KS-associated herpes virus positive but without diagnosis of KS).

Each patient receives an individualized regimen comprising standard antiretroviral drugs. Antiretroviral therapy continues in the absence of progression of KS requiring chemotherapy or other specific therapy, development of another malignancy requiring chemotherapy or immunotherapy, or inability to maintain HIV RNA levels below 15,000 copies/mL on at least 2 sequential evaluations even when the therapeutic changes to optimize antiretroviral agents have been exhausted.

PROJECTED ACCRUAL: A total of 24 patients (9 with KS and 15 at risk for developing KS) will be accrued for this study.

Study Design

Primary Purpose: Treatment




antiviral therapy


Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
United States


Active, not recruiting


National Cancer Institute (NCI)

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:56:46-0400

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