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A Study of Patients With AIDS Syndrome

Primary Purpose

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

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Sarcoma, Kaposi focused on measuring 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)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Willow Clinic
  • San Francisco Gen Hosp
  • Marin County Specialty Clinic
  • San Mateo AIDS Program / Stanford Univ
  • Stanford Univ Med Ctr
  • Univ of Hawaii
  • Indiana Univ Hosp
  • Charity Hosp / Tulane Univ Med School
  • Tulane Univ School of Medicine
  • Johns Hopkins Hosp
  • Harvard (Massachusetts Gen Hosp)
  • SUNY / Erie County Med Ctr at Buffalo
  • Bellevue Hosp / New York Univ Med Ctr
  • Mem Sloan - Kettering Cancer Ctr
  • St Mary's Hosp (Univ of Rochester/Infectious Diseases)
  • Univ of Rochester Medical Center
  • Univ of North Carolina
  • Duke Univ Med Ctr
  • Univ of Cincinnati
  • Case Western Reserve Univ
  • MetroHealth Med Ctr
  • Ohio State Univ Hosp Clinic
  • Univ of Washington

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
September 11, 2008
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00001120
Brief Title
A Study of Patients With AIDS Syndrome
Official Title
Oncogenic Viral Pathogenesis and Cancer Risk Factors Among Patients With the Acquired Immunodeficiency Syndrome: A Prospective Cohort Study
Study Type
Observational

2. Study Status

Record Verification Date
May 2006
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma, Kaposi, Lymphoma, Non-Hodgkin, HIV Infections, Lymphoma, AIDS-Related
Keywords
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)

7. Study Design

Enrollment
5000 (false)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David A. Wohl
Organizational Affiliation
Univ of North Carolina
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ann C. Collier
Organizational Affiliation
Univ of Washington
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
William G. Powderly
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Charles S. Rabkin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Willow Clinic
City
Menlo Park
State/Province
California
ZIP/Postal Code
94025
Country
United States
Facility Name
San Francisco Gen Hosp
City
San Francisco
State/Province
California
ZIP/Postal Code
941102859
Country
United States
Facility Name
Marin County Specialty Clinic
City
San Rafael
State/Province
California
ZIP/Postal Code
94903
Country
United States
Facility Name
San Mateo AIDS Program / Stanford Univ
City
Stanford
State/Province
California
ZIP/Postal Code
943055107
Country
United States
Facility Name
Stanford Univ Med Ctr
City
Stanford
State/Province
California
ZIP/Postal Code
943055107
Country
United States
Facility Name
Univ of Hawaii
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96816
Country
United States
Facility Name
Indiana Univ Hosp
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
462025250
Country
United States
Facility Name
Charity Hosp / Tulane Univ Med School
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Tulane Univ School of Medicine
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Johns Hopkins Hosp
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Harvard (Massachusetts Gen Hosp)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
SUNY / Erie County Med Ctr at Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
Bellevue Hosp / New York Univ Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Mem Sloan - Kettering Cancer Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
St Mary's Hosp (Univ of Rochester/Infectious Diseases)
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Univ of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Univ of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
275997215
Country
United States
Facility Name
Duke Univ Med Ctr
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Univ of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
452670405
Country
United States
Facility Name
Case Western Reserve Univ
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
MetroHealth Med Ctr
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
441091998
Country
United States
Facility Name
Ohio State Univ Hosp Clinic
City
Columbus
State/Province
Ohio
ZIP/Postal Code
432101228
Country
United States
Facility Name
Univ of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

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A Study of Patients With AIDS Syndrome

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