HIV Infections Clinical Trial
Official title:
Oncogenic Viral Pathogenesis and Cancer Risk Factors Among Patients With the Acquired Immunodeficiency Syndrome: A Prospective Cohort Study
The purpose of this study is to find out why cancers develop in HIV-positive patients.
Cancer is a leading cause of death in AIDS patients. Common cancers in HIV-infected patients
include Kaposi's sarcoma (KS) and non-Hodgkin's lymphoma (NHL), a cancer of the immune
system. Risk factors include certain chemicals, viruses, and perhaps even anti-HIV drugs.
Doctors would like to find out which risk factors are most important and how they relate to
cancer in AIDS patients.
AIDS-associated malignancy represents a model system for investigations of carcinogenesis.
There are few human conditions in which cancer rates are of the magnitude they are in HIV
infection. While studies have investigated pre-cancer markers in HIV-infected patients, they
have not correlated these markers with tumor samples. This study contributes to
understanding oncogenesis of HIV-associated malignancies by establishing a collection of
tumors linked with pre-cancer sera and lymphocyte specimens, as well as prospective
questionnaire data.
At study entry, patients receive a comprehensive physical exam. Clinic staff interview the
patient to collect data regarding medication history (particularly antiretroviral exposure),
diet, occupational history, substance abuse, and sexual practices. This information is used
to identify behavioral and environmental factors contributing to oncogenesis. In addition,
baseline blood samples are analyzed for HHV-8 and EBV levels, anti-EBV and anti-HHV-8
antibodies, CD23, Th2 cytokines, tumor growth factors, chromosomal translocations associated
with NHL, and other potential predictors of malignancy. At Month 6 and annually thereafter,
patient records are abstracted for data on vital status, AIDS-defining illnesses,
medications, and most recent CD4+ T cell and HIV RNA levels. At Years 1, 2, and 3, patients
undergo physical exams and blood tests for malignancy surveillance. Any malignancies are
biopsied and analyzed for oncogene identification and virology. The medical records of
patients who die on study are reviewed to determine the cause of death and to rule out
unreported cancer. No treatment is provided by this study.
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