Viral Load in Blood and Lymph Tissues in People Living With HIV

ConditionHIV
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

About this trial

This is a study to determine the effect of the human immunodeficiency virus (HIV) on lymphoid tissues (e.g., lymph nodes) as compared to peripheral white blood cells. We have shown in previous studies that the lymph node is a major site of accumulation of HIV in the body, as well as being a site where much of the viral replication occurs which leads to the destruction of the body's immune system. To better understand the role of the lymph node in HIV infection and destruction of one s immunity, we wish to examine both the virus itself as well as the effects it is having on various types of white cells (called lymphocytes) obtained simultaneously from both peripheral blood and lymph nodes of people living with HIV (PLWH). We also need to look at cells derived from blood and lymph nodes from people who do not have HIV to serve as a control for experiments. We may also use your lymph node tissue and blood cells to attempt to make new T-cells, or rebuild the immune cells, in the laboratory by adding various factors or other substances released by different cells in the body. If you are living with HIV, you may be asked to undergo a second biopsy six weeks to 12 months after the first biopsy. Because of the ability of aspirin to interfere with blood clotting, you must have refrained from the use of aspirin for one week (7 days) prior to the biopsy date. You also cannot use non-aspirin containing, non-steroidal, anti-inflammatory medications (e.g., ibuprofen, naproxen, and similar drugs) one week (7 days) prior to the biopsy. In addition, pregnancy testing will be performed on all females at the time of admission and a positive test will exclude you from participation. No participant will undergo more than six biopsies while participating in this study unless a particular research requires it....

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

HIV status 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.

Absolute neutrophil count of greater than 1000/mm^3

Disqualifiers

Women who are pregnant and/or breast-feeding

Currently abusing alcohol or other drugs including narcotics or cocaine

Participants 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.

Trial population

Both healthy volunteers and individuals with HIV will be recruited from other existing NIAID studies and from the DC metropolitan area.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

400 Participants
are grouped into 2 trial groups
Group A: Individuals with HIV
Group B: Individuals without HIV

Trial outcomes

Primary outcomes

1

Relative burden of HIV

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 mononuclear cells versus the lymphoid tissues (LT) and bone marrow (BM) in people living with HIV (PLWH).

Time frame
Throughout
2

Immunoregulatory mechanisms

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 lymphoid tissues (LT) of people living with HIV (PLWH).

Time frame
Throughout
3

Effect of Therapy on Viral Burden and Immune Activation

We wish to examine the effect of therapy on viral burden and/or immune activation in the immunoregulatory pathways observed in lymphocyte subsets in lmyphoid tissues (LT) versus peripheral blood mononuclear cells. For LT specimen, the analyses can be performed both on intact tissue sections and excised cells.

Time frame
Throughout

Secondary outcomes

Other outcomes

Sponsors and contacts

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