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.
- Conditions
- HIV Infections
- Registration Number
- NCT00000818
- 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.
- Detailed Description
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.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (9)
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
Cedars Sinai Med Ctr🇺🇸Los Angeles, California, United States