Viral Load in Blood and Lymph Tissues of HIV-Infected Individuals
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| ClinicalTrials.gov Identifier: NCT00001316 |
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Recruitment Status :
Recruiting
First Posted : November 4, 1999
Last Update Posted : May 19, 2022
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Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
| Tracking Information | |||||||||
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| First Submitted Date | November 3, 1999 | ||||||||
| First Posted Date | November 4, 1999 | ||||||||
| Last Update Posted Date | May 19, 2022 | ||||||||
| Actual Study Start Date | August 26, 1992 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures |
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| Original Primary Outcome Measures | Not Provided | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures | Not Provided | ||||||||
| Original Secondary Outcome Measures | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Viral Load in Blood and Lymph Tissues of HIV-Infected Individuals | ||||||||
| Official Title | A Study of Viral Burden in Peripheral Blood Versus Lymphoid and Bone Marrow Tissue in HIV-Infected Individuals | ||||||||
| Brief Summary | Our laboratory has previously demonstrated that lymph nodes are a major reservoir for human immunodeficiency virus (HIV) and a major site of active virus replication in infected individuals. There is at least a 10 fold greater viral burden per given number of CD4+ T lymphocytes obtained from the lymph nodes versus the peripheral blood in the same infected individual. These data have been accumulated predominantly in individuals with progressive generalized lymphadenopathy (CDC Class A1 and A2). It is unclear at present whether this pattern holds true for all categories of HIV infected individuals. We have proposed that the seeding of lymph nodes by HIV early in the course of HIV infection and the persistent production of virus in lymph nodes throughout the course of infection are major factors in the pathogenesis of HIV in virtually all infected individuals. In addition, it is likely that the selective perturbations of various T cell subsets (i.e., V-B classes of CD4+T cells) that have been observed in peripheral blood are much more dramatic in the lymph node given the greater viral burden in the lymph node compared to the peripheral blood. In order to investigate this hypothesis, it is essential that we study simultaneously lymph nodes and peripheral blood from the same individuals and that we study different individuals at various stages of disease from early in the course of infection (CDC Class A) to advanced disease (CDC Class B and C). If, as we suspect, there is active virus replication in the lymph node early in the course of infection, even at a time when there is little virus burden or active replication in the peripheral blood, this would justify anti-retroviral therapy at the earliest possible time in the course of infection. In addition, in certain patients who are about to initiate treatment with an anti-retroviral agent such as zidovudine or didanosine through their private physician, it would be important to know whether treatment actually reduces the viral burden and virus replication in lymph nodes. The effect of therapy on viral burden and replication will be compared in the lymph node versus peripheral blood mononuclear cells and both of these parameters will be compared with the level of plasma viremia. | ||||||||
| Detailed Description | We are studying the pathogenesis of HIV infection and other immune dysfunctions. Because of the lack of an adequate animal model it is generally necessary to utilize human peripheral blood and lymphoid tissues cells for studying aspects of either in vivo or in vitro HIV infection. A dichotomy exists between the amount of HIV that can be measured in peripheral blood compared to lymphoid tissue, as well as the types of immune cells that reside in each compartment. We wish to be able to continue to elucidate many pathogenic aspects of HIV infection and other immune dysfunctions using human peripheral blood mononuclear cells and intact tissue or cells obtained from two major lymphoid organs, lymph nodes and bone marrow. | ||||||||
| Study Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Both healthy volunteers and individuals with HIV will be recruited from other existing NIAID studies and from the DC metropolitan area. | ||||||||
| Condition | HIV | ||||||||
| Intervention | Not Provided | ||||||||
| Study Groups/Cohorts |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
400 | ||||||||
| Original Enrollment |
300 | ||||||||
| Study Completion Date | Not Provided | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria |
EXCLUSION CRITERIA:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts |
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| Listed Location Countries | United States | ||||||||
| Removed Location Countries | Belgium | ||||||||
| Administrative Information | |||||||||
| NCT Number | NCT00001316 | ||||||||
| Other Study ID Numbers | 920125 92-I-0125 |
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| Has Data Monitoring Committee | Not Provided | ||||||||
| U.S. FDA-regulated Product | Not Provided | ||||||||
| IPD Sharing Statement | Not Provided | ||||||||
| Responsible Party | National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ) | ||||||||
| Study Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators |
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| PRS Account | National Institutes of Health Clinical Center (CC) | ||||||||
| Verification Date | January 27, 2022 | ||||||||