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.

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

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). Patien...

Gender

ALL

Eligibility 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.

Trial Officials