A Study of Patients With AIDS Syndrome
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00001120 |
Recruitment Status
:
Completed
First Posted
: August 31, 2001
Last Update Posted
: September 12, 2008
|
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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.
Condition or disease |
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Sarcoma, Kaposi Lymphoma, Non-Hodgkin HIV Infections Lymphoma, AIDS-Related |
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.
Study Type : | Observational |
Enrollment : | 5000 participants |
Official Title: | Oncogenic Viral Pathogenesis and Cancer Risk Factors Among Patients With the Acquired Immunodeficiency Syndrome: A Prospective Cohort Study |


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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
You may be eligible for this trial if you:
- Are HIV-positive.
- Have a CD4+ cell count of 200 cells/mm3 or below.
- Are 18 years of age or older.
Exclusion Criteria
You will not be eligible for this trial if you:
- Are not available for follow-up for at least 3 years.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001120
United States, California | |
Willow Clinic | |
Menlo Park, California, United States, 94025 | |
San Francisco Gen Hosp | |
San Francisco, California, United States, 941102859 | |
Marin County Specialty Clinic | |
San Rafael, California, United States, 94903 | |
San Mateo AIDS Program / Stanford Univ | |
Stanford, California, United States, 943055107 | |
Stanford Univ Med Ctr | |
Stanford, California, United States, 943055107 | |
United States, Hawaii | |
Univ of Hawaii | |
Honolulu, Hawaii, United States, 96816 | |
United States, Indiana | |
Indiana Univ Hosp | |
Indianapolis, Indiana, United States, 462025250 | |
United States, Louisiana | |
Charity Hosp / Tulane Univ Med School | |
New Orleans, Louisiana, United States, 70112 | |
Tulane Univ School of Medicine | |
New Orleans, Louisiana, United States, 70112 | |
United States, Maryland | |
Johns Hopkins Hosp | |
Baltimore, Maryland, United States, 21287 | |
United States, Massachusetts | |
Harvard (Massachusetts Gen Hosp) | |
Boston, Massachusetts, United States, 02114 | |
United States, New York | |
SUNY / Erie County Med Ctr at Buffalo | |
Buffalo, New York, United States, 14215 | |
Bellevue Hosp / New York Univ Med Ctr | |
New York, New York, United States, 10016 | |
Mem Sloan - Kettering Cancer Ctr | |
New York, New York, United States, 10021 | |
St Mary's Hosp (Univ of Rochester/Infectious Diseases) | |
Rochester, New York, United States, 14642 | |
Univ of Rochester Medical Center | |
Rochester, New York, United States, 14642 | |
United States, North Carolina | |
Univ of North Carolina | |
Chapel Hill, North Carolina, United States, 275997215 | |
Duke Univ Med Ctr | |
Durham, North Carolina, United States, 27710 | |
United States, Ohio | |
Univ of Cincinnati | |
Cincinnati, Ohio, United States, 452670405 | |
Case Western Reserve Univ | |
Cleveland, Ohio, United States, 44106 | |
MetroHealth Med Ctr | |
Cleveland, Ohio, United States, 441091998 | |
Ohio State Univ Hosp Clinic | |
Columbus, Ohio, United States, 432101228 | |
United States, Washington | |
Univ of Washington | |
Seattle, Washington, United States, 98104 |
Study Chair: | David A. Wohl | Univ of North Carolina | |
Study Chair: | Ann C. Collier | Univ of Washington | |
Study Chair: | William G. Powderly | ||
Principal Investigator: | Charles S. Rabkin |
ClinicalTrials.gov Identifier: | NCT00001120 History of Changes |
Other Study ID Numbers: |
ACTG A5035 |
First Posted: | August 31, 2001 Key Record Dates |
Last Update Posted: | September 12, 2008 |
Last Verified: | May 2006 |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Prospective Studies Sarcoma, Kaposi Herpesvirus 4, Human Acquired Immunodeficiency Syndrome Cohort Studies Risk Factors |
Lymphoma, AIDS-Related Antibodies, Viral Lymphoproliferative Disorders Viral Load Herpesvirus, Kaposi Sarcoma-Associated Translocation (Genetics) |
Additional relevant MeSH terms:
Lymphoma HIV Infections Sarcoma Immunologic Deficiency Syndromes Acquired Immunodeficiency Syndrome Lymphoma, Non-Hodgkin Sarcoma, Kaposi Lymphoma, AIDS-Related Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Neoplasms, Connective and Soft Tissue Slow Virus Diseases Herpesviridae Infections DNA Virus Infections Neoplasms, Vascular Tissue Lymphoma, B-Cell |