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NCT00001120 Clinical Trial

A Study of Patients With AIDS Syndrome

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00001120
Other study ID # ACTG A5035
Secondary ID
Status Completed
Phase N/A
First received November 2, 1999
Last updated September 11, 2008

Study information
Verified date May 2006
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 5000
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

N/A

Related Conditions & MeSH terms

Locations
Country Name City State
United States Johns Hopkins Hosp Baltimore Maryland
United States Harvard (Massachusetts Gen Hosp) Boston Massachusetts
United States SUNY / Erie County Med Ctr at Buffalo Buffalo New York
United States Univ of North Carolina Chapel Hill North Carolina
United States Univ of Cincinnati Cincinnati Ohio
United States Case Western Reserve Univ Cleveland Ohio
United States MetroHealth Med Ctr Cleveland Ohio
United States Ohio State Univ Hosp Clinic Columbus Ohio
United States Duke Univ Med Ctr Durham North Carolina
United States Univ of Hawaii Honolulu Hawaii
United States Indiana Univ Hosp Indianapolis Indiana
United States Willow Clinic Menlo Park California
United States Charity Hosp / Tulane Univ Med School New Orleans Louisiana
United States Tulane Univ School of Medicine New Orleans Louisiana
United States Bellevue Hosp / New York Univ Med Ctr New York New York
United States Mem Sloan - Kettering Cancer Ctr New York New York
United States St Mary's Hosp (Univ of Rochester/Infectious Diseases) Rochester New York
United States Univ of Rochester Medical Center Rochester New York
United States San Francisco Gen Hosp San Francisco California
United States Marin County Specialty Clinic San Rafael California
United States Univ of Washington Seattle Washington
United States San Mateo AIDS Program / Stanford Univ Stanford California
United States Stanford Univ Med Ctr Stanford California

Sponsors (2)
Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

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