Protocol Number: 01-C-0038

Title:

Collection of Blood, Bone Marrow, Tumor, or Tissue Samples from Patients with HIV Infection, KSHV Infection, Viral-related Pre-malignant Lesions, and/or Cancer

Number:

01-C-0038

Summary:

This study will collect blood and tissue samples from patients with human immunodeficiency virus (HIV) infection, Kaposi's sarcoma-associated herpes virus infection (KSHV) or with cancers associated with viral infections. The samples will be used for research relating to the patient's cancer or virus, to the immune system, or to methods of devising new therapies for these conditions.

Patients 18 years or older with HIV infection or malignancy, or high-risk exposure to HIV or KSHV may be eligible for this study.

Upon entering the study, patients will have 3 to 4 tablespoons of blood drawn for use in experimental research studies. Additional samples of the same amount may be requested periodically at later intervals.

Patients may be asked to have a biopsy (removal of a sample of tumor or normal tissue) as part of their medical care, or for another research study they are participating in. Part of the sample obtained will be used for research. If a biopsy is not required for other reasons, permission will be requested to perform a biopsy as part of this protocol. Samples may be obtained by withdrawing bone marrow through a small needle, removing fluid from the chest or abdomen through a needle or other instrument; withdrawing a tumor sample through a needle (called a needle aspiration), or removing a sample by making a small incision into or around the tumor. The method used will depend in part upon the location of the tumor.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria:

INCLUSION CRITERIA:

Age 18 years or older.

ECOG performance status less than or equal to 3.

At least one of the following: Exposure risk to HIV, KSHV, or HPV; HIV seropositive; KSHV seropositive; EBV seropositive; HTLV-1 seropositive; Malignancy, Castleman's disease, or skin lesions with appearance of Kaposi's sarcoma; or Cervical or anal intraepithelial lesion.

Patients not requiring biopsy for a medical indication can be included on the study solely for the purpose of obtaining research samples, including blood, pleural fluid, peritoneal fluid, or biopsy samples providing the biopsy or aspiration procedure is of low risk.

EXCLUSION CRITERIA:

Inability to provide informed consent.

Special Instructions: Currently Not Provided

Keywords:

HIV

KSHV

HHV-8

Cancer

AIDS

Recruitment Keywords:

None

Conditions:

HIV Infection

Kaposi's Sarcoma

Investigational Drug(s):

None

Investigational Device(s):

None

Contacts:

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:

Regulatiomn of HIV-1 protease activity through cysteine modification

HIV-2 protease is inactiviated after oxidation at the dimer interface and activity can be partly restored with methionine sulphoxide reductase

HIV-specific immunity following immunization with HIV synthetic envelope peptides in asymptomatic HIV-infected patients

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Networks and Applications, CC.

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Warren Grant Magnuson Clinical Center (CC)
National Institutes of Health (NIH)
Bethesda, Maryland 20892. Last update: 10/23/2004