A Study of Patients With AIDS Syndrome
- Conditions
- Lymphoma, Non-HodgkinHIV InfectionsSarcoma, KaposiLymphoma, AIDS-Related
- Registration Number
- NCT00001120
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5000
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (23)
Univ of Hawaii
🇺🇸Honolulu, Hawaii, United States
Willow Clinic
🇺🇸Menlo Park, California, United States
San Francisco Gen Hosp
🇺🇸San Francisco, California, United States
Marin County Specialty Clinic
🇺🇸San Rafael, California, United States
San Mateo AIDS Program / Stanford Univ
🇺🇸Stanford, California, United States
Stanford Univ Med Ctr
🇺🇸Stanford, California, United States
Indiana Univ Hosp
🇺🇸Indianapolis, Indiana, United States
Charity Hosp / Tulane Univ Med School
🇺🇸New Orleans, Louisiana, United States
Tulane Univ School of Medicine
🇺🇸New Orleans, Louisiana, United States
Mem Sloan - Kettering Cancer Ctr
🇺🇸New York, New York, United States
Harvard (Massachusetts Gen Hosp)
🇺🇸Boston, Massachusetts, United States
Johns Hopkins Hosp
🇺🇸Baltimore, Maryland, United States
Bellevue Hosp / New York Univ Med Ctr
🇺🇸New York, New York, United States
St Mary's Hosp (Univ of Rochester/Infectious Diseases)
🇺🇸Rochester, New York, United States
SUNY / Erie County Med Ctr at Buffalo
🇺🇸Buffalo, New York, United States
Univ of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
Univ of Rochester Medical Center
🇺🇸Rochester, New York, United States
Duke Univ Med Ctr
🇺🇸Durham, North Carolina, United States
Univ of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Case Western Reserve Univ
🇺🇸Cleveland, Ohio, United States
MetroHealth Med Ctr
🇺🇸Cleveland, Ohio, United States
Univ of Washington
🇺🇸Seattle, Washington, United States
Ohio State Univ Hosp Clinic
🇺🇸Columbus, Ohio, United States