Viral Load in Blood and Lymph Tissues of HIV-Infected Individuals
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ClinicalTrials.gov Identifier: NCT00001316 |
Recruitment Status
:
Recruiting
First Posted
: November 4, 1999
Last Update Posted
: March 29, 2018
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Condition or disease |
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HIV Infection |
Study Type : | Observational |
Estimated Enrollment : | 400 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | A Study of Viral Burden in Peripheral Blood Versus Lymphoid and Bone Marrow Tissue in HIV-Infected Individuals |
Study Start Date : | March 18, 1992 |

- We also wish to investigate the HIV-specific B-cell and T-cell responses in the different subsets of cells in both peripheral blood, aswell as BM and LT of HIV-infected individuals. [ Time Frame: Throughout ]
- In addition, we wish to delineate the precise nature of the immunoregulatory mechanisms and altered homing patterns that contribute to the perturbations in the phenotype and functions of various lymphocyte subsets in peripheral blood versus the ... [ Time Frame: Throughout ]
- The purpose of this project is to determine the relative burden of human immunodeficiency virus (HIV) and/or associated changes in hematopoiesis and immune activation as well as HIV-specific responses in the various subsets of peripheral blood m... [ Time Frame: Throughout ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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INCLUSION CRITERIA:
- HIV infection must be documented by a licensed ELISA and confirmed either by Western blot, or plasma viremia.
- Aged 18 years or older.
- Ability to give informed, written consent.
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The following laboratory values:
- Absolute neutrophil count of greater than 1000/mm3.
- PT, PTT within normal limits (unless PTT is elevated in presence of positive lupus anticoagulant in a subject with no prior history of abnormal bleeding).
- Adequate blood counts (HIV positive volunteers: hemoglobin greater than or equal to 9.0 g/dL, HCT greater than or equal to 28%, platelets greater than or equal to 75,000; HIV negative volunteers: hemoglobin greater than or equal to 11.2 g/dL, HCT greater than or equal to 34.1%, platelets greater than or equal to 150,000).
- Blood pressure less than or equal to 180/100; pulse rate 50-100, unless a lower pulse rate is considered normal for the volunteer.
- HIV negative individuals will qualify as control subjects.
- Patients must have a clinically palpable lymph node in an easily accessible location.
EXCLUSION CRITERIA:
- Women who are pregnant and/or breast-feeding.
- Currently abusing alcohol or other drugs, including narcotics or cocaine.
- Patients with AIDS dementia or with an AIDS related malignancy other than minimal Kaposi's sarcoma.
- No Aspirin or Non-Steroidal Anti-inflammatory medications (NSIADs) 7 days prior to procedure. Acetaminophen (Tylenol) is permitted at any time.
- Any medical condition for which the PI feels LN BX might be contraindicated.
- Subjects in which sedation is planned. Use of narcotics (other than as prescribed by a physician) or cocaine less than 1 week prior to the date of biopsy will be excluded.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001316
Contact: Catherine A Seamon, R.N. | (301) 402-3481 | cseamon@cc.nih.gov | |
Contact: Susan Moir, Ph.D. | (301) 402-4559 | sm221a@nih.gov |
United States, Maryland | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
Bethesda, Maryland, United States, 20892 | |
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 prpl@cc.nih.gov |
Principal Investigator: | Susan Moir, Ph.D. | National Institute of Allergy and Infectious Diseases (NIAID) |
Additional Information:
Publications:
Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00001316 History of Changes |
Other Study ID Numbers: |
920125 92-I-0125 |
First Posted: | November 4, 1999 Key Record Dates |
Last Update Posted: | March 29, 2018 |
Last Verified: | July 12, 2017 |
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ):
Lymph Node Polymerase Chain Reaction (PCR) In Situ Hybridization AIDS Excisional Biopsy |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |