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.
1 other identifier
interventional
18
1 country
9
Brief Summary
PRIMARY: To determine the effect of 8 weeks of zidovudine (AZT) treatment on the HIV-1 burden in peripheral blood and lymphoid tissue in HIV-1-infected, AZT-naive patients with CD4+ T lymphocyte counts between 100 and 500 cells/mm3. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 hiv-infections
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJuly 29, 2008
May 1, 1996
November 2, 1999
July 28, 2008
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Concurrent Medication:
- 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.
You may not qualify if:
- Concurrent Medication:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Cedars Sinai Med Ctr
Los Angeles, California, 90048, United States
Palo Alto Veterans Affairs Health Care System
Palo Alto, California, 94304, United States
AIDS Community Research Consortium
Redwood City, California, 94063, United States
Mount Zion Med Ctr / UCSF
San Francisco, California, 94115, United States
North Broward Hosp District
Fort Lauderdale, Florida, 33316, United States
Goodgame Med Group
Maitland, Florida, 32751, United States
Univ of Illinois
Chicago, Illinois, 60612, United States
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, 75235, United States
Baylor College of Medicine / Houston Veterans Adm Med Ctr
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Cohn J
- STUDY CHAIR
Bilello J
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- NIH
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
July 29, 2008
Record last verified: 1996-05