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.

National Institute of Allergy and Infectious Diseases (NIAID)

Status and phase: Completed; Phase 1

Conditions: HIV Infections

Treatments: Drug: Zidovudine

Study type: Interventional

Funder types: NIH

Identifiers

NCT00000818

DATRI 012

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.