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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Bristol-Myers Squibb Glaxo Wellcome |
Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00001024 |
Immunopathogenesis objectives: To compare and quantitatively determine HIV burden and HIV replication in peripheral blood (PB) and lymphoid tissue (LT). To determine the degree to which antiretroviral therapy alters HIV replication in LT.
Clinical objectives: To gain insight into the degree of correlation between immunologic surrogate markers for HIV disease (e.g., CD4, beta-2 microglobulin) as compared to measures of HIV replication in PB and LT. To assess changes in PB and LT viral burden after antiretroviral therapy and to determine its ability to predict an antiviral response.
One of the major problems in defining the immunopathogenic changes in HIV infections has been the inability to correlate the extent of loss of immunologic function with the number of HIV-infected CD4+ cells in the peripheral blood. Few studies exist that measure viral burden in lymph nodes of HIV-infected individuals. Researchers hope to find out whether the amount of HIV virus or markers for the virus in the body's lymph tissue is a better measure of disease progression than the amount of virus or markers for the virus in the blood.
Condition | Intervention |
HIV Infections |
Drug: Zidovudine Drug: Didanosine |
MedlinePlus related topics: | AIDS |
Drug Information available for: | Zidovudine Didanosine |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Multicenter, Open-Label Study of Viral Burden in Peripheral Blood Versus Lymphoid Tissue Before and After Antiretroviral Therapy in HIV-Infected Individuals Without AIDS (NOTE: One Arm Receives no Treatment) |
Estimated Enrollment: | 32 |
One of the major problems in defining the immunopathogenic changes in HIV infections has been the inability to correlate the extent of loss of immunologic function with the number of HIV-infected CD4+ cells in the peripheral blood. Few studies exist that measure viral burden in lymph nodes of HIV-infected individuals. Researchers hope to find out whether the amount of HIV virus or markers for the virus in the body's lymph tissue is a better measure of disease progression than the amount of virus or markers for the virus in the blood.
Sixteen antiretroviral-naive patients are randomized to either remain antiretroviral-naive (no treatment) or receive zidovudine daily (treatment). Additionally, 16 patients with 26 or more weeks of ongoing zidovudine (AZT) therapy are randomized to either continue on their prestudy AZT regimen or add didanosine (ddI) daily to their baseline AZT dose. Patients remain on their assigned treatment arms for 8 weeks. A lymph node biopsy is performed on day 0 and at week 8. Patients are evaluated at weeks 2, 4, 6, 8 and 9.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Recommended:
Concurrent Treatment:
Allowed:
Patients must have:
Patients with prior AZT therapy must have received a stable dose of 300-600 mg daily for 26 or more weeks.
Prior Medication:
Required in patients with prior ongoing therapy:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms and conditions are excluded:
Concurrent Medication:
Excluded:
Concurrent Treatment:
Excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
History of alcohol abuse (patients with prior AZT treatment).
United States, California | |||||
Palo Alto Veterans Affairs Health Care System | |||||
Palo Alto, California, United States, 94304 | |||||
Mount Zion Med Ctr / UCSF | |||||
San Francisco, California, United States, 94115 | |||||
Kaiser Permanente Med Ctr | |||||
San Francisco, California, United States, 94115 | |||||
United States, Illinois | |||||
Univ of Illinois | |||||
Chicago, Illinois, United States, 60612 | |||||
United States, Maryland | |||||
Univ of Maryland at Baltimore | |||||
Baltimore, Maryland, United States, 21201 | |||||
United States, New York | |||||
SUNY / Health Sciences Ctr at Stony Brook | |||||
Stony Brook, New York, United States, 117948153 | |||||
United States, North Carolina | |||||
Duke Univ Med Ctr | |||||
Durham, North Carolina, United States, 27710 | |||||
United States, Pennsylvania | |||||
Univ of Pittsburgh | |||||
Pittsburgh, Pennsylvania, United States, 15261 |
National Institute of Allergy and Infectious Diseases (NIAID) |
Bristol-Myers Squibb |
Glaxo Wellcome |
Study Chair: | J Cohn | |
Study Chair: | M Niu |
Click here for more information about Zidovudine 
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Click here for more information about Didanosine 
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Cohen OJ, Pantaleo G, Graziosi C, Niu M, Fauci AS. Effect of antiretroviral therapy on HIV burden and replication in lymphoid tissue. DATRI 003 Study Group. Int Conf AIDS. 1994 Aug 7-12;10(1):7 (abstract no 001B)
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Study ID Numbers: | DATRI 003 |
First Received: | November 2, 1999 |
Last Updated: | August 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00001024 |
Health Authority: | United States: Federal Government |
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