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HLA and KIR Associations With Infectious Viral Agents in an HIV Cohort of Women (WIHS)


N/A
18 Years
N/A
Not Enrolling
Female
Liver Cancer, Nonneoplastic Condition, Precancerous Condition

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Trial Information

HLA and KIR Associations With Infectious Viral Agents in an HIV Cohort of Women (WIHS)


OBJECTIVES:

- Examine the role of HLA and killer immunoglobulin-like receptors (KIR) in the natural
history of human papillomavirus (HPV), hepatitis C virus (HCV), and hepatitis B virus
(HBV) in HIV-positive and HIV-negative women.

- Test the hypothesis that KIR and HLA genotype may play a role in the pathogenesis of
HIV, HPV, HCV, and HBV infection.

- Determine the relationship between KIR and HLA genes and risk of HIV infection,
according to likely source of virus exposure (sexual versus IV) and demographic factors
such as race.

- Determine the relationship between KIR and HLA genes and CD4+ cell counts and serum HIV
RNA levels.

- Determine the relationship between KIR and HLA genes and incidence of AIDS and other
clinical endpoints, including AIDS-associated malignancies and opportunistic
infections.

- Determine the relationship between KIR and HLA genes and the response to highly active
antiretroviral treatment (HAART), as measured by increases in CD4+ T-cell levels,
reduction in serum HIV RNA levels, and reduction in AIDS rates.

- Determine the relationship between KIR and HLA genes and risk of HCV infection among
injecting drug users, according to viral subtype and demographic factors, such as race.

- Determine the relationship between KIR and HLA genes and persistence of HCV infection.

- Determine the relationship between KIR and HLA genes and incidence of HCV-related
end-stage liver disease and/or hepatocellular carcinoma.

- Determine the relationship between KIR and HLA genes and response to immunotherapy, as
measured by viral load and liver function tests.

- Determine the relationship between KIR and HLA genes and the natural history of HPV and
cervical dysplasia in HIV-positive and HIV-negative women.

- Determine the relationship between KIR and HLA genes and persistence of HBV infection.

- Determine the relationship between KIR and HLA genes and incidence of HBV-related
end-stage liver disease and/or hepatocellular carcinoma.

OUTLINE: This is a multicenter study.

Blood samples are analyzed for genomic DNA isolated from lymphoblastoid B-cell lines or from
peripheral blood lymphocytes and used for genotyping of HLA and killer immunoglobulin-like
receptors (KIR) genes. High-resolution HLA class I and class II genotyping is performed
using the HLA class I genes (HLA-A, -B, -C), which are amplified using polymerase chain
reaction (PCR) and sequenced.

Previously collected clinical data is also evaluated. Patients were followed every 6 months
on the Women's Interagency HIV Study and underwent physical and gynecological examinations
and completed questionnaires. Blood samples, cervical lavage specimens, and cervical
cytology samples were also collected at that time.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- DNA and relevant clinical data from properly consented Women's Interagency HIV Study
(WIHS) subjects meeting 1 of the following criteria:

- HIV positive

- HIV negative but at high risk of HIV infection

PATIENT CHARACTERISTICS:

- Not specified

PRIOR CONCURRENT THERAPY:

- Not specified

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

Infection

Safety Issue:

No

Principal Investigator

Stephen J. O'Brien

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute - Frederick

Authority:

United States: Federal Government

Study ID:

CDR0000594251

NCT ID:

NCT00897689

Start Date:

August 2002

Completion Date:

Related Keywords:

  • Liver Cancer
  • Nonneoplastic Condition
  • Precancerous Condition
  • adult primary liver cancer
  • adult primary hepatocellular carcinoma
  • high-grade squamous intraepithelial lesion
  • low-grade squamous intraepithelial lesion
  • HIV infection
  • human papilloma virus infection
  • hepatitis B infection
  • hepatitis C infection
  • HIV Infections
  • Hepatitis
  • Hepatitis A
  • Hepatitis B
  • Hepatitis C
  • Liver Neoplasms
  • Precancerous Conditions

Name

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral OfficeBethesda, Maryland  20892-1182