Clinical trial NCT00001120: 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
Overall status: COMPLETED
Conditions: 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)
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
Collaborators: name: National Cancer Institute (NCI)
First posted: 2001-08-31
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

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.

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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Menlo Park
country: United States
facility: Willow Clinic
state: California
city: San Francisco
country: United States
facility: San Francisco Gen Hosp
state: California
city: San Rafael
country: United States
facility: Marin County Specialty Clinic
state: California
city: Stanford
country: United States
facility: San Mateo AIDS Program / Stanford Univ
state: California
city: Stanford
country: United States
facility: Stanford Univ Med Ctr
state: California
city: Honolulu
country: United States
facility: Univ of Hawaii
state: Hawaii
city: Indianapolis
country: United States
facility: Indiana Univ Hosp
state: Indiana
city: New Orleans
country: United States
facility: Charity Hosp / Tulane Univ Med School
state: Louisiana
city: New Orleans
country: United States
facility: Tulane Univ School of Medicine
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins Hosp
state: Maryland
city: Boston
country: United States
facility: Harvard (Massachusetts Gen Hosp)
state: Massachusetts
city: Buffalo
country: United States
facility: SUNY / Erie County Med Ctr at Buffalo
state: New York
city: New York
country: United States
facility: Bellevue Hosp / New York Univ Med Ctr
state: New York
city: New York
country: United States
facility: Mem Sloan - Kettering Cancer Ctr
state: New York
city: Rochester
country: United States
facility: St Mary's Hosp (Univ of Rochester/Infectious Diseases)
state: New York
city: Rochester
country: United States
facility: Univ of Rochester Medical Center
state: New York
city: Chapel Hill
country: United States
facility: Univ of North Carolina
state: North Carolina
city: Durham
country: United States
facility: Duke Univ Med Ctr
state: North Carolina
city: Cincinnati
country: United States
facility: Univ of Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: Case Western Reserve Univ
state: Ohio
city: Cleveland
country: United States
facility: MetroHealth Med Ctr
state: Ohio
city: Columbus
country: United States
facility: Ohio State Univ Hosp Clinic
state: Ohio
city: Seattle
country: United States
facility: Univ of Washington
state: Washington
Study officials:
affiliation: Univ of North Carolina
name: David A. Wohl
role: STUDY_CHAIR
affiliation: Univ of Washington
name: Ann C. Collier
role: STUDY_CHAIR
name: William G. Powderly
role: STUDY_CHAIR
name: Charles S. Rabkin
role: PRINCIPAL_INVESTIGATOR
References: