Overview
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.
Status:
Completed
Completed
Trial end date:
1969-12-31
1969-12-31
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)Treatments:
Zidovudine
Criteria
Inclusion CriteriaConcurrent 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.
Exclusion Criteria
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.