The Safety and Effectiveness of Human Monoclonal Antibody, F105, in the Treatment of HIV
Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001
Trial Information
Current as of January 15, 2025
Completed
Keywords
ClinConnect Summary
Early in the course of HIV infection, the primary humoral immune response appears to be highly strain specific and to be directed at a hypervariable portion of the viral gp120. The F105 human monoclonal antibody reacts with the CD4 binding region of gp120 and has been shown to neutralize the IIIB, SF2, and MN strains of HIV at concentrations readily achievable in humans.
In Part A, three cohorts of four patients each receive a single intravenous (IV) injection of F105 human monoclonal antibody at 1 of 3 doses. The IV catheter will remain in the patient's arm for 12 hours after injection fo...
Gender
ALL
Eligibility criteria
- • 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.
Trial Officials
Samore MH
Study Chair
About National Institute Of Allergy And Infectious Diseases (Niaid)
The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Boston, Massachusetts, United States
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
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