Evaluation of the Changes in HIV-1 Burden in Peripheral Blood and Lymphoid Tissue Following Zidovudine ( AZT ) Treatment in HIV-1-Infected Patients With CD4+ Cells Between 100 and 500 Cells/mm3.
NCT ID: NCT00000818
Last Updated: 2008-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
18 participants
INTERVENTIONAL
Brief Summary
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SECONDARY: To determine the extent to which apoptosis (programmed cell death) occurs in these patients.
In previous trials of AZT treatment in HIV-infected patients, an antiviral effect has been clearly demonstrated by quantitative measurement of virus in plasma and peripheral blood mononuclear cells. However, the lymphoid tissues appear to be a major reservoir for HIV-1 and a major site of virus replication in HIV-infected persons. Further data is needed to assess the effect of treatment on viral burden and HIV-1 replication in lymphoid tissue.
Detailed Description
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Patients receive AZT daily for 8 weeks and are followed in clinic at weeks 2, 4, 6, 8, 9, and 14 (or possibly via telephone call at week 14). Patients undergo a lymph node biopsy at day 0 and week 8.
Conditions
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Keywords
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Study Design
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TREATMENT
NONE
Interventions
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Zidovudine
Eligibility Criteria
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Inclusion Criteria
Allowed:
* Prophylaxis against AIDS-related opportunistic infections.
* Supportive therapies, such as medications for nausea, vomiting, anemia, and analgesia.
Patients must have:
* HIV infection.
* CD4 count 100 - 500 cells/mm3.
* At least two palpable lymph nodes.
* Plasma viremia.
* No CURRENT AIDS-defining conditions.
* No prior antiretroviral treatment.
Exclusion Criteria
Excluded during the first 8 weeks of study:
* Other antiretroviral agents.
* Steroids.
* Interleukins.
* Interferons.
* Cytotoxic chemotherapy.
Prior Medication:
Excluded:
* Prior antiretroviral therapy.
* Prior cytotoxic chemotherapy.
* Acute therapy for an infection or another medical illness within 14 days prior to study entry.
18 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Principal Investigators
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Cohn J
Role: STUDY_CHAIR
Bilello J
Role: STUDY_CHAIR
Locations
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Cedars Sinai Med Ctr
Los Angeles, California, United States
Palo Alto Veterans Affairs Health Care System
Palo Alto, California, United States
AIDS Community Research Consortium
Redwood City, California, United States
Mount Zion Med Ctr / UCSF
San Francisco, California, United States
North Broward Hosp District
Fort Lauderdale, Florida, United States
Goodgame Med Group
Maitland, Florida, United States
Univ of Illinois
Chicago, Illinois, United States
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, United States
Baylor College of Medicine / Houston Veterans Adm Med Ctr
Houston, Texas, United States
Countries
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Other Identifiers
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DATRI 012
Identifier Type: -
Identifier Source: org_study_id