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Home > "V" Clinical Trials Conditions > Viral Load in Blood and Lymph Tissues of HIV-Infected Individuals  Viral Load in Blood and Lymph Tissues of HIV-Infected Individuals
Viral Load in Blood and Lymph Tissues of HIV-Infected Individuals
For Condition: HIV Infection,Viremia
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: This study will examine and compare lymph tissues and peripheral white blood cells in HIV-infected patients. Lymph nodes are a major site of viral accumulation and replication. Study of the effects of the virus on white cells from both peripheral blood and lymph nodes of the same individual may further understanding of the role of lymph nodes in the course of infection and immune destruction. Cells from uninfected normal volunteers will also be collected to serve as a control for experiments. HIV-infected persons 18 years of age and older and normal healthy volunteers may be eligible for this study. Infected individuals at various stages of infection-from early in the course of infection to advanced disease- will be enrolled. Candidates will be screened with a physical examination and blood tests. Women will have a urine pregnancy test. Patients with AIDS dementia or with an AIDS-related cancer other than minimal Kaposi's sarcoma may not participate. Participants will undergo the following procedures: - Blood drawing - Blood samples will be collected through a needle in an arm vein. No more than 400 cc (less than a pint) of blood will be drawn during the study period - Lymph node biopsy - A lymph node from the groin, armpit or neck will be removed for examination and testing. The biopsy will be done under local anesthesia and possibly with a sedative to minimize discomfort. HIV-infected patients may be asked to undergo a second biopsy 6 weeks to 12 months after the first one. The findings of this study may have implications for treatment. If virus replication in the lymph nodes is found to occur early in the course of infection before large amounts of virus can be detected in peripheral blood, it may prove beneficial to start anti-viral therapy as early as possible.
Details: 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-beta 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.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA 1. HIV infection must be documented by a licensed ELISA and confirmed either by Western blot, positive HIV culture, positive HIV antigen, plasma viremia, or second antibody test positive by a method other than ELISA. 2. Aged 18 years or older. 3. Ability to give informed, written consent. 4. The following laboratory values: a) Absolute neutrophil count of greater than 1000/mm3. b) PT, PTT within normal limits. c) 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 12.0 g/dL, HCT greater than or equal to 38%, platelets greater than or equal to 150,000). d) Blood pressure less than or equal to 180/100; pulse rate 50-100, unless a lower pulse rate is considered normal for the volunteer. 5. CD4+T cell count of any level. 6. Patients may be receiving anti-retroviral therapy. 7. Patients may be receiving prophylaxis for opportunistic infections. 8. HIV negative individuals will qualify as control subjects. EXCLUSION CRITERIA: 1. Women who are pregnant and/or breast-feeding. 2. Currently abusing alcohol or other drugs. 3. Patients with AIDS dementia or with an AIDS related malignancy other than minimal Kaposi's sarcoma. 4. Patients who have taken more than two 650 mg doses of aspirin less than one week prior to the date of biopsy. 5. Patients who have taken non-aspirin containing, non-steroidal, anti-inflammatory medications (e.g. ibuprofen, naproxen, and similar drugs) within 24 hours prior to the date of biopsy. 6. Any medical condition for which the PI feels LN BX might be contraindicated.
Total Enrollment: 300
Location and Contact Information:
National Institute of Allergy and Infectious Diseases (NIAID) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 920125; 92-I-0125
Study Start Date: March 18, 1992
Record last reviewed: March 5, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001316
Other Viremia Studies:
1. Subcutaneously Administered Interleukin-2 Therapy in HIV-Infected Patients
2. Capravirine to Treat Children with HIV Infection
3. Study of Patients with Strongyloides stercoralis Infection
4. Long-Term Survival with HIV: Psychological and Behavioral Factors Associated with the Transition from Adolescence to Young Adulthood
5. HIV Maintenance Therapy with T-20 During HAART Interruption
Related Studies:
Other Viremia Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Viral Load in Blood and Lymph Tissues of HIV-Infected Individuals
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