Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
5000 participants
OBSERVATIONAL
Brief Summary
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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
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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.
Conditions
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Keywords
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Eligibility Criteria
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Inclusion Criteria
* Are HIV-positive.
* Have a CD4+ cell count of 200 cells/mm3 or below.
* Are 18 years of age or older.
Exclusion Criteria
* Are not available for follow-up for at least 3 years.
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Principal Investigators
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David A. Wohl
Role: STUDY_CHAIR
Univ of North Carolina
Ann C. Collier
Role: STUDY_CHAIR
Univ of Washington
William G. Powderly
Role: STUDY_CHAIR
Charles S. Rabkin
Role: PRINCIPAL_INVESTIGATOR
Locations
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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
Univ of Hawaii
Honolulu, Hawaii, 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
Johns Hopkins Hosp
Baltimore, Maryland, United States
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, United States
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States
Mem Sloan - Kettering Cancer Ctr
New York, New York, United States
St Mary's Hosp (Univ of Rochester/Infectious Diseases)
Rochester, New York, United States
Univ of Rochester Medical Center
Rochester, New York, United States
Univ of North Carolina
Chapel Hill, North Carolina, 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
Ohio State Univ Hosp Clinic
Columbus, Ohio, United States
Univ of Washington
Seattle, Washington, United States
Countries
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Other Identifiers
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ACTG A5035
Identifier Type: -
Identifier Source: org_study_id