Completed

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

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What is being collected

Data Collection

Who is being recruted

Blood-Borne Infections+35

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Observational
See protocol details

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: September 12, 2008
Sourced from a government-validated database.Claim as a partner

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.

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: September 12, 2008
Sourced from a government-validated database.Claim as a partner

Protocol

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

5000 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesChromosome AberrationsCommunicable DiseasesDNA Virus InfectionsHemic and Lymphatic DiseasesHerpesviridae InfectionsImmunologic Deficiency SyndromesImmune System DiseasesImmunoproliferative DisordersInfectionsLymphatic DiseasesLymphomaNeoplasmsNeoplasms by Histologic TypeNeoplasms, Vascular TissuePathologic ProcessesRetroviridae InfectionsRNA Virus InfectionsSarcomaSexually Transmitted DiseasesSlow Virus DiseasesPathological Conditions, Signs and SymptomsTumor Virus InfectionsVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsLymphoma, B-CellNeoplasms, Connective and Soft TissueAcquired Immunodeficiency SyndromeLymphoma, Non-HodgkinLymphoproliferative DisordersSarcoma, KaposiTranslocation, GeneticHIV InfectionsLymphoma, AIDS-RelatedEpstein-Barr Virus Infections

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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 23 locations

Willow Clinic

Menlo Park, United StatesOpen Willow Clinic in Google Maps

San Francisco Gen Hosp

San Francisco, United States

Marin County Specialty Clinic

San Rafael, United States

San Mateo AIDS Program / Stanford Univ

Stanford, United States
Completed23 Study Centers