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:

BACKGROUND: A number of important scientific advances can be made through the study of blood, bone marrow, tumor, or other tissue samples from patients with HIV infection, infection with Kaposi's sarcoma associated herpesvirus (KSHV), infection with other oncogenic viruses, or cancer. This protocol provides a mechanism to effect a variety of such studies.

OBJECTIVES: Acquisition of serum, circulating cells, bone marrow, and tumor or

normal tissue samples from patients with HIV infection, KSHV infection, or with cancer.

ELIGIBILITY: Eligibility criteria include age 18 years or older and at lest 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.

DESIGN: Blood samples may be collected at the initial visit, and at follow-up visits. Tumor samples may be obtained by fine needle aspirate, by removal of pleural or peritoneal fluid, by skin punch biopsy, or by excisional biopsy, providing the tumor is accessible with minimal risk to the patients. Specific risks will be described in a separate consent to be obtained at the time of the biopsy. Samples will be studied in the HIV and AIDS Malignancy Branch, CCR, NCI; laboratories in NCI-Frederick; or those of collaborating investigators.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled

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: such procedure include fine needle aspirates, bone marrow aspirate and biopsy, or excisional biopsy. Such biopsies can be completely sepatate from any other protocol or evaluation process.

EXCLUSION CRITERIA:

Inability to provide informed consent.

Special Instructions:

Currently Not Provided

Keywords:

HIV

KSHV

HHV-8

Cancer

AIDS

Recruitment Keyword(s):

None

Condition(s):

HIV Infection

Kaposi's Sarcoma

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Cancer Institute

Contact(s):

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
Phone: 1-888-NCI-1937
Fax: Not Listed
Electronic Address: ncicssc@mail.nih.gov

Citation(s):

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

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