Specimen Collections From Participants With HIV Infection, KSHV Infection, Viral-Related Pre-malignant Lesions and Cancer

HIV Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00006518
• Other study ID #: 010038
• Secondary ID: 01-C-0038
• Status: Recruiting
• Start date: December 6, 2000

Study information

• Verified date: May 28, 2024
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Anaida Widell
• Phone: (240) 760-6074
• Email: anaida.widell[@]nih.gov
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 affect a variety of such studies.

OBJECTIVES:

-Acquisition of serum, circulating cells, bone marrow, and tumor or normal tissue samples from participants with HIV infection, KSHV infection, or with cancer.

ELIGIBILITY:

-Eligibility criteria include age 18 years or older and 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.

DESIGN:

• Up to 999 subjects will be enrolled in this study.

• Blood samples may be collected at the initial visit, and at follow-up visits.

• Other fluids/excretions may be collected (such as urine, saliva, semen, and stool).

• 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 participants.

• 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.

Description:

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 affect a variety of such studies.

OBJECTIVES:

-Acquisition of serum, circulating cells, bone marrow, and tumor or normal tissue samples from participants with HIV infection, KSHV infection, or with cancer.

ELIGIBILITY:

-Eligibility criteria include age 18 years or older and 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.

DESIGN:

• Up to 999 subjects will be enrolled in this study.

• Blood samples may be collected at the initial visit, and at follow-up visits.

• Other fluids/excretions may be collected (such as urine, saliva, semen, and stool).

• 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 participants.

• 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.

Other known NCT identifiers

• NCT00898651

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 999
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• 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 seropositiv

• HTLV-1 seropositive

NOTE: infection with HIV, KSHV, EBV, and HTLV-1 are life-long, so if patients have previously been seropositive or have had a disease associated with KSHV (KS, primary effusion lymphoma [PEL], or KSHV-multicentric Castleman s disease), this is sufficient to meet this criterion for eligibility.

• Malignancy, Castleman's disease, or skin lesions with appearance of Kaposi's sarcoma

• Cervical or anal intraepithelial lesion

• Ability of subject to understand and the willingness to sign a written informed consent document. Participants could have a witness signature if they are either blind or illiterate, etc.

EXCLUSION CRITERIA:

Inability to provide informed consent.

Related Conditions & MeSH terms

• Castleman Disease
• HIV
• HIV Infections
• Infections
• Kaposi's Sarcoma
• Lymphoma
• Lymphomas
• Multicentric Castleman's Disease
• Primary Effusion Lymphoma
• Sarcoma, Kaposi
• Virus Diseases

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Davis DA, Dorsey K, Wingfield PT, Stahl SJ, Kaufman J, Fales HM, Levine RL. Regulation of HIV-1 protease activity through cysteine modification. Biochemistry. 1996 Feb 20;35(7):2482-8. doi: 10.1021/bi951525k. — View Citation

Davis DA, Newcomb FM, Moskovitz J, Wingfield PT, Stahl SJ, Kaufman J, Fales HM, Levine RL, Yarchoan R. HIV-2 protease is inactivated after oxidation at the dimer interface and activity can be partly restored with methionine sulphoxide reductase. Biochem J. 2000 Mar 1;346 Pt 2(Pt 2):305-11. — View Citation

Pinto LA, Berzofsky JA, Fowke KR, Little RF, Merced-Galindez F, Humphrey R, Ahlers J, Dunlop N, Cohen RB, Steinberg SM, Nara P, Shearer GM, Yarchoan R. HIV-specific immunity following immunization with HIV synthetic envelope peptides in asymptomatic HIV-infected patients. AIDS. 1999 Oct 22;13(15):2003-12. doi: 10.1097/00002030-199910220-00002. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acquisition of serum, circulating cells, bone marrow, and tumor or normal tissue samples from participants with HIV infection, KSHV infection, or with cancer.	Proportion of participants that have contributed serum, circulating cells, bone marrow, and tumor or normal tissue samples	Ongoing

External Links

•   NIH Clinical Center Detailed Web Page