A Phase I Clinical Trial to Study the Toxicity, Pharmacokinetics, and Efficacy of Human Monoclonal Antibody, F105, for Treating Human Immunodeficiency Virus Infection.
Data Collection
Infections
Treatment Study
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 for subsequent drawing of blood samples. The third group (highest dose) will be studied only after the first two groups are analyzed for pharmacokinetics. No more than two patients are enrolled per week. Patients on Part A undergo follow-up three to four times within the first week after injection and weekly thereafter for 7 weeks. Pharmacokinetic and toxicity data generated from Part A will be used to select two dose levels for intermittent administration in Part B. In this part, cohorts of four to six patients receive one of two doses of F105 for 8-12 weeks. Per 9/30/94 amendment, eight patients receive one dose of F105 every 21 days for four doses (dose determined from analysis of Part A data).
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.8 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location