A Study of Patients With AIDS Syndrome

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

Overall Status

Completed

CT.gov ID

NCT00001120

Collaborator

National Cancer Institute (NCI) (NIH)

5,000

Enrollment

Locations

217.4

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sarcoma, Kaposi Lymphoma, Non-Hodgkin HIV Infections Lymphoma, AIDS-Related

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.

Study Design

Study Type:

Observational

Official Title:

Oncogenic Viral Pathogenesis and Cancer Risk Factors Among Patients With the Acquired Immunodeficiency Syndrome: A Prospective Cohort Study

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Willow Clinic	Menlo Park	California	United States	94025
2	San Francisco Gen Hosp	San Francisco	California	United States	941102859
3	Marin County Specialty Clinic	San Rafael	California	United States	94903
4	San Mateo AIDS Program / Stanford Univ	Stanford	California	United States	943055107
5	Stanford Univ Med Ctr	Stanford	California	United States	943055107
6	Univ of Hawaii	Honolulu	Hawaii	United States	96816
7	Indiana Univ Hosp	Indianapolis	Indiana	United States	462025250
8	Charity Hosp / Tulane Univ Med School	New Orleans	Louisiana	United States	70112
9	Tulane Univ School of Medicine	New Orleans	Louisiana	United States	70112
10	Johns Hopkins Hosp	Baltimore	Maryland	United States	21287
11	Harvard (Massachusetts Gen Hosp)	Boston	Massachusetts	United States	02114
12	SUNY / Erie County Med Ctr at Buffalo	Buffalo	New York	United States	14215
13	Bellevue Hosp / New York Univ Med Ctr	New York	New York	United States	10016
14	Mem Sloan - Kettering Cancer Ctr	New York	New York	United States	10021
15	St Mary's Hosp (Univ of Rochester/Infectious Diseases)	Rochester	New York	United States	14642
16	Univ of Rochester Medical Center	Rochester	New York	United States	14642
17	Univ of North Carolina	Chapel Hill	North Carolina	United States	275997215
18	Duke Univ Med Ctr	Durham	North Carolina	United States	27710
19	Univ of Cincinnati	Cincinnati	Ohio	United States	452670405
20	Case Western Reserve Univ	Cleveland	Ohio	United States	44106
21	MetroHealth Med Ctr	Cleveland	Ohio	United States	441091998
22	Ohio State Univ Hosp Clinic	Columbus	Ohio	United States	432101228
23	Univ of Washington	Seattle	Washington	United States	98104