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A Study of Patients With AIDS Syndrome

This study has been completed.

Sponsors and Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
National Cancer Institute (NCI)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00001120
  Purpose

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
Sarcoma, Kaposi
Lymphoma, Non-Hodgkin
HIV Infections
Lymphoma, AIDS-Related

MedlinePlus related topics:   AIDS    Cancer    Kaposi's Sarcoma    Lymphoma    Soft Tissue Sarcoma   

U.S. FDA Resources

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

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment:   5000

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001120

Locations
United States, California
San Francisco Gen Hosp    
      San Francisco, California, United States, 941102859
Stanford Univ Med Ctr    
      Stanford, California, United States, 943055107
San Mateo AIDS Program / Stanford Univ    
      Stanford, California, United States, 943055107
Marin County Specialty Clinic    
      San Rafael, California, United States, 94903
Willow Clinic    
      Menlo Park, California, United States, 94025
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
Univ of Rochester Medical Center    
      Rochester, New York, United States, 14642
Mem Sloan - Kettering Cancer Ctr    
      New York, New York, United States, 10021
Bellevue Hosp / New York Univ Med Ctr    
      New York, New York, United States, 10016
SUNY / Erie County Med Ctr at Buffalo    
      Buffalo, New York, United States, 14215
St Mary's Hosp (Univ of Rochester/Infectious Diseases)    
      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
Case Western Reserve Univ    
      Cleveland, Ohio, United States, 44106
Univ of Cincinnati    
      Cincinnati, Ohio, United States, 452670405
Ohio State Univ Hosp Clinic    
      Columbus, Ohio, United States, 432101228
MetroHealth Med Ctr    
      Cleveland, Ohio, United States, 441091998
United States, Washington
Univ of Washington    
      Seattle, Washington, United States, 98104

Sponsors and Collaborators

Investigators
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    
  More Information


Haga clic aquí para ver información sobre este ensayo clínico en español.  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   ACTG A5035
First Received:   November 2, 1999
Last Updated:   September 11, 2008
ClinicalTrials.gov Identifier:   NCT00001120
Health Authority:   United States: Federal Government

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)

Study placed in the following topic categories:
Sexually Transmitted Diseases, Viral
Malignant mesenchymal tumor
Soft tissue sarcomas
Lymphoma, B-Cell
Neoplasms, Connective and Soft Tissue
Kaposi sarcoma
Lymphoma, AIDS-Related
Retroviridae Infections
Lymphoma
Lymphoma, AIDS-related
Immunoproliferative Disorders
Sarcoma, Kaposi
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
Herpesviridae Infections
Virus Diseases
Lymphatic Diseases
Antibodies
HIV Infections
B-cell lymphomas
Sexually Transmitted Diseases
Sarcoma
DNA Virus Infections
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin

Additional relevant MeSH terms:
Neoplasms
RNA Virus Infections
Pathologic Processes
Disease
Neoplasms by Histologic Type
Slow Virus Diseases
Immune System Diseases
Syndrome
Neoplasms, Vascular Tissue
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on December 03, 2008




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