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Home > "A" Clinical Trials Conditions > A Study of Patients with AIDS Syndrome A Study of Patients with AIDS Syndrome
A Study of Patients with AIDS Syndrome
For Condition: Sarcoma, Kaposi,Lymphoma, Non-Hodgkin,HIV Infections,Lymphoma, AIDS-Related
Status: Terminated
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Observational, Natural History, Case Control
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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.
Total Enrollment: 5000
Location and Contact Information:
Overall Study Official:
DavidWohl, Study Chair, Univ of North Carolina
Case Western Reserve Univ
Cleveland, Ohio, 44106
United States
San Francisco Gen Hosp
San Francisco, California, 941102859
United States
Duke Univ Med Ctr
Durham, North Carolina, 27710
United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405
United States
MetroHealth Med Ctr
Cleveland, Ohio, 441091998
United States
Mem Sloan - Kettering Cancer Ctr
New York City, New York, 10021
United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Charity Hosp / Tulane Univ Med School
New Orleans, Louisiana, 70112
United States
St Mary's Hosp (Univ of Rochester/Infectious Diseases)
Rochester, New York, 14642
United States
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
United States
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Univ of Washington
Seattle, Washington, 98104
United States
Univ of Hawaii
Honolulu, Hawaii, 96816
United States
Stanford Univ Med Ctr
Stanford, California, 943055107
United States
Marin County Specialty Clinic
San Rafael, California, 94903
United States
San Mateo AIDS Program / Stanford Univ
Stanford, California, 943055107
United States
Willow Clinic
Menlo Park, California, 94025
United States
Additional Information:
Study ID Numbers: ACTG A5035;
Study Start Date:
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001120
Other Hiv Infections Studies:
1. The Use of Chemotherapy Plus Radiotherapy Plus Azidothymidine in Patients with AIDS-Related Lymph Node Cancer
2. Pegfilgrastim PBPC Mobilization Study
3. A Study of Mitoguazone Dihydrochloride in Patients with AIDS-Related Non-Hodgkin's Lymphoma
4. A Pilot Study of Non-Hodgkin's Lymphoma: Chemotherapy and Blood Levels of Organochlorines
5. Phase II Study of Novantrone(R) (Mitoxantrone) and Etoposide in Patients with HIV Associated Large Cell and Immunoblastic Lymphomas
Related Studies:
Other HIV Infections Clinical Trials
Other California Clinical Trials
Other San Francisco Clinical Trials
A Study of Patients with AIDS Syndrome
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