HIVNCT00006518
Specimen Collections From Participants With HIV Infection, KSHV Infection, Viral-Related Pre-malignant Lesions and Cancer
An observational study of HIV and Kaposi's Sarcoma, run by National Cancer Institute (NCI) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- HIV, Kaposi's Sarcoma, Lymphomas
- How many people
- 1,029 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Dec 2000to not given
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary Clinical
Who may be able to join
- 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
Show all 12Show fewer
- EBV seropositive
- HTLV-1 seropositive
- NOTE: infection with HIV, KSHV, EBV, and HTLV-1 are life-long, so if participants have previously been seropositive or have had a disease associated with KSHV (KS, primary effusion lymphoma [PEL], or KSHV-multicentric Castleman s disease [MCD]), this is sufficient to meet this criterion for eligibility.
- Malignancy, MCD, or skin lesions with appearance of KS
- Cervical or anal intraepithelial lesion
- Ability of participant to understand and the willingness to sign a written informed consent document.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
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
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.
Read more
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.
Read the detailed 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 (KS); or cervical or anal intraepithelial lesion.
DESIGN:
- Up to 999 participants will be provide samples 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.
- Conditions
- HIV, Kaposi's Sarcoma, Lymphomas, Multicentric Castleman's Disease, Primary Effusion Lymphoma
- Keywords
- Tumor, Viruses, HIV, KSHV, AIDS, Natural History
- Medical subject headings
- Sarcoma, Kaposi, Lymphoma, Multi-centric Castleman's Disease, Lymphoma, Primary Effusion, Neoplasms, Virus Diseases, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Participants with HIV infection, KSHV infection, or with cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2000 (estimated)
- Study start6 Dec 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,029 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Robert Yarchoan, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006518
- Sponsor's protocol ID
- 010038
- Other IDs
- 01-C-0038
- Status last verified
- 13 Oct 2026
- First submitted
- 22 Nov 2000
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD recorded in the medical record will be shared with intramural investigators upon request. @@@@@@@@@@@@In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP
Publications
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.
PubMed 8652592Davis 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.
PubMed 10677347Pinto 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.
PubMed 10546852Mercado Matos J, Marshall VA, Cornejo Castro EM, Miley WJ, Labo N, Roshan R, Ekwede I, Widell A, Agwu I, Namubiru M, Witterholt M, Yarchoan R, Lurain K, Whitby D, Ramaswami R. Kaposi Sarcoma Herpesvirus (KSHV) Subtypes and Impact on Outcomes in KSHV-Associated Diseases. J Infect Dis. 2026 Sep 23;234(3):e572-e582. doi: 10.1093/infdis/jiag168.
PubMed 41845569Lage SL, Ramaswami R, Rocco JM, Rupert A, Davis DA, Lurain K, Manion M, Whitby D, Yarchoan R, Sereti I. Inflammasome activation in patients with Kaposi sarcoma herpesvirus-associated diseases. Blood. 2024 Oct 3;144(14):1496-1507. doi: 10.1182/blood.2024024144.
PubMed 38941593Ramaswami R, Tagawa T, Mahesh G, Serquina A, Koparde V, Lurain K, Dremel S, Li X, Mungale A, Beran A, Ohler ZW, Bassel L, Warner A, Mangusan R, Widell A, Ekwede I, Krug LT, Uldrick TS, Yarchoan R, Ziegelbauer JM. Transcriptional landscape of Kaposi sarcoma tumors identifies unique immunologic signatures and key determinants of angiogenesis. J Transl Med. 2023 Sep 22;21(1):653. doi: 10.1186/s12967-023-04517-5.
PubMed 37740179