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

18 Years
Not Enrolling
Sarcoma, Kaposi, Lymphoma, Non-Hodgkin, HIV Infections, Lymphoma, AIDS-Related

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Trial Information

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

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.

Inclusion 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.

Type of Study:


Study Design:


Principal Investigator

David A. Wohl

Investigator Role:

Study Chair

Investigator Affiliation:

Univ of North Carolina


United States: Federal Government

Study ID:

ACTG A5035



Start Date:

Completion Date:

Related Keywords:

  • Sarcoma, Kaposi
  • Lymphoma, Non-Hodgkin
  • HIV Infections
  • Lymphoma, AIDS-Related
  • 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)
  • Acquired Immunodeficiency Syndrome
  • HIV Infections
  • Immunologic Deficiency Syndromes
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Sarcoma, Kaposi
  • Lymphoma, AIDS-Related
  • Sarcoma



San Francisco Gen Hosp San Francisco, California  941102859
Bellevue Hosp / New York Univ Med Ctr New York, New York  10016
Mem Sloan - Kettering Cancer Ctr New York, New York  10021
Univ of Rochester Medical Center Rochester, New York  14642
Indiana Univ Hosp Indianapolis, Indiana  462025250
Tulane Univ School of Medicine New Orleans, Louisiana  70112
Harvard (Massachusetts Gen Hosp) Boston, Massachusetts  02114
SUNY / Erie County Med Ctr at Buffalo Buffalo, New York  14215
Univ of North Carolina Chapel Hill, North Carolina  275997215
Duke Univ Med Ctr Durham, North Carolina  27710
Ohio State Univ Hosp Clinic Columbus, Ohio  432101228
Univ of Washington Seattle, Washington  98105
Johns Hopkins Hosp Baltimore, Maryland  21287
Charity Hosp / Tulane Univ Med School New Orleans, Louisiana  70112
Univ of Cincinnati Cincinnati, Ohio  452670405
Stanford Univ Med Ctr Stanford, California  943055107
San Mateo AIDS Program / Stanford Univ Stanford, California  943055107
Univ of Hawaii Honolulu, Hawaii  96816
MetroHealth Med Ctr Cleveland, Ohio  441091998
Case Western Reserve Univ Cleveland, Ohio  44106
Willow Clinic Menlo Park, California  94025
Marin County Specialty Clinic San Rafael, California  94903
St Mary's Hosp (Univ of Rochester/Infectious Diseases) Rochester, New York  14642