The Safety and Effectiveness of Human Monoclonal Antibody, F105, in the Treatment of HIV

Inclusion Criteria

Concurrent Medication:

PART B ONLY. Allowed:

• Concomitant AZT or other antiretroviral drugs if patient is on a stable dose of such therapy within 3 months prior to study entry.

Patients must have:

• Documented HIV-1 infection.
• CD4 count 200 - 500 cells/mm3 (Part A) or <= 400 cells/mm3 (Part B, per amendment).
• No diagnosis of AIDS (Part A only, per amendment).
• Life expectancy of at least 6 months.

Part B patients only (per amendment):

• Primary (viral) isolates sensitive to F105 antibody using the yield reduction assay currently under development by ACTG, determined within 15-90 days prior to study entry.
• Plasma viremia by qualitative plasma culture.
• NO active opportunistic infection within 6 weeks prior to drawing of first isolate.
• NO AIDS-related malignancy other than minimal Kaposi's sarcoma.

Prior Medication:

Allowed:

• Prior AZT or other nucleoside antiviral agents.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Evidence of active renal disease as manifested by sediment containing red or white cell casts.

Concurrent Treatment:

Excluded:

• Red cell transfusions administered to maintain hemoglobin at acceptable level or alleviate symptoms of anemia.

Prior Medication:

Excluded within 6 weeks prior to study entry:

• Intravenous gamma globulin.
• Chemotherapy.
• Corticosteroids.
• Other experimental therapy.

EXCLUDED IN ALL PATIENTS:

• Immunosuppressive treatments, cytokine therapy, or biologic response modifiers not included in this study, including interferons or adjuvant treatment for chronic and severe fungal infections such as cryptococcal meningitis.
• Intravenous gamma globulin.
• Chemotherapy.
• Corticosteroids.
• Other experimental therapy.
• G-CSF, GM-CSF, or erythropoietin.

EXCLUDED IN PART A ONLY:

• Drugs known to enhance or block metabolism of other drugs.

EXCLUDED IN PART B ONLY:

• AZT or other antiretroviral drugs IF INITIATED during or within 1 month after completion of study.

Active alcohol or drug abuse that may compromise ability to comply with study requirements.