Expired Study
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Bethesda, Maryland 20892


Purpose:

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.


Study summary:

OBJECTIVES: - 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.


Criteria:

DISEASE CHARACTERISTICS: - Diagnosis of Kaposi's sarcoma (KS) OR - KS-associated herpes virus/human herpes virus-8 positive - HIV positive - Ineligible if antiretroviral therapy not in best interest of patient PATIENT CHARACTERISTICS: Age: - 13 and over Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Not specified Renal: - Not specified Other: - No condition that periodically requires immunosuppressive therapy (e.g., asthma) PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 4 weeks since prior cytokine therapy - No concurrent cytokines - No concurrent antiangiogenic agents - No other concurrent immune-based therapy Chemotherapy: - No concurrent cytotoxic chemotherapy Endocrine therapy: - At least 4 weeks since prior corticosteroid therapy - Concurrent physiologic anabolic steroid replacement therapy allowed - No concurrent supraphysiologic doses of corticosteroid therapy Radiotherapy: - Not specified Surgery: - Not specified Other: - At least 4 weeks since prior specific anti-KS therapy - No concurrent specific anti-KS therapy except local therapy to small lesions of cosmetic significance not included in KS assessment field - No concurrent antiherpes therapy with potent anti-KS-associated herpes virus activity (e.g., foscarnet, cidofovir) - No concurrent therapy for HIV-associated opportunistic complications


NCT ID:

NCT00020319


Primary Contact:

Principal Investigator
Robert Yarchoan, MD
NCI - HIV and AIDS Malignancy Branch


Backup Contact:

N/A


Location Contact:

Bethesda, Maryland 20892
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 12, 2017

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