Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001120
Status:
COMPLETED
Last Update Posted:
2008-09-12
First Post:
1999-11-02
Brief Title:
A Study of Patients With AIDS Syndrome
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Oncogenic Viral Pathogenesis and Cancer Risk Factors Among Patients With the Acquired Immunodeficiency Syndrome A Prospective Cohort Study
Status:
COMPLETED
Status Verified Date:
2006-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Kaposis sarcoma KS and non-Hodgkins 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
Cancer is a leading cause of death in AIDS patients Common cancers in HIV-infected patients include Kaposis sarcoma KS and non-Hodgkins 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:
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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: