A Study of Patients With AIDS Syndrome

September 11, 2008 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Menlo Park, California, United States, 94025
        • Willow Clinic
      • San Francisco, California, United States, 941102859
        • San Francisco Gen Hosp
      • San Rafael, California, United States, 94903
        • Marin County Specialty Clinic
      • Stanford, California, United States, 943055107
        • San Mateo AIDS Program / Stanford Univ
      • Stanford, California, United States, 943055107
        • Stanford Univ Med Ctr
    • Hawaii
      • Honolulu, Hawaii, United States, 96816
        • Univ of Hawaii
    • Indiana
      • Indianapolis, Indiana, United States, 462025250
        • Indiana Univ Hosp
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane Univ School of Medicine
      • New Orleans, Louisiana, United States, 70112
        • Charity Hosp / Tulane Univ Med School
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hosp
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Harvard (Massachusetts Gen Hosp)
    • New York
      • Buffalo, New York, United States, 14215
        • SUNY / Erie County Med Ctr at Buffalo
      • New York, New York, United States, 10016
        • Bellevue Hosp / New York Univ Med Ctr
      • New York, New York, United States, 10021
        • Mem Sloan - Kettering Cancer Ctr
      • Rochester, New York, United States, 14642
        • Univ of Rochester Medical Center
      • Rochester, New York, United States, 14642
        • St Mary's Hosp (Univ of Rochester/Infectious Diseases)
    • North Carolina
      • Chapel Hill, North Carolina, United States, 275997215
        • Univ of North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke Univ Med Ctr
    • Ohio
      • Cincinnati, Ohio, United States, 452670405
        • Univ of Cincinnati
      • Cleveland, Ohio, United States, 44106
        • Case Western Reserve Univ
      • Cleveland, Ohio, United States, 441091998
        • MetroHealth Med Ctr
      • Columbus, Ohio, United States, 432101228
        • Ohio State Univ Hosp Clinic
    • Washington
      • Seattle, Washington, United States, 98104
        • Univ of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

National Cancer Institute (NCI)

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

September 12, 2008

Last Update Submitted That Met QC Criteria

September 11, 2008

Last Verified

May 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACTG A5035

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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