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
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
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 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Treatments:
Zidovudine
Criteria
Inclusion Criteria

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.

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.