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The Safety and Effectiveness of Human Monoclonal Antibody, F105, in the Treatment of HIV Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on The Safety and Effectiveness of Human Monoclonal Antibody, F105, in the Treatment of HIV conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. The Safety and Effectiveness of Human Monoclonal Antibody, F105, in the Treatment of HIV Clinical research trials and The Safety and Effectiveness of Human Monoclonal Antibody, F105, in the Treatment of HIV health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including The Safety and Effectiveness of Human Monoclonal Antibody, F105, in the Treatment of HIV. The Safety and Effectiveness of Human Monoclonal Antibody, F105, in the Treatment of HIV Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a The Safety and Effectiveness of Human Monoclonal Antibody, F105, in the Treatment of HIV clinical trial. Participants oftentimes recieve the most expert healthcare available for their The Safety and Effectiveness of Human Monoclonal Antibody, F105, in the Treatment of HIV condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "T" Clinical Trials Conditions > The Safety and Effectiveness of Human Monoclonal Antibody, F105, in the Treatment of HIV  The Safety and Effectiveness of Human Monoclonal Antibody, F105, in the Treatment of HIV
The Safety and Effectiveness of Human Monoclonal Antibody, F105, in the Treatment of HIV
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: To determine the safety and pharmacokinetics of F105 human monoclonal antibody both following a single dose and during intermittent administration in HIV-infected patients. To determine specific dose concentrations sufficient to achieve efficacy and avoid toxicity. To determine the effect of F105 on virologic, immunologic, and serologic parameters. 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.
Details: 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).
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 8
Location and Contact Information:
Overall Study Official:
SamoreMH, Study Chair,
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215
United States
Additional Information:
Study ID Numbers: ACTG 232;
Study Start Date:
Record last reviewed: April 1996
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001105
Other Hiv Infections Studies:
1. Ganciclovir Implant Study for Cytomegalovirus Retinitis
2. A Pilot Study to Evaluate the Effects of Subcutaneously Administered Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor in Pediatric HIV-Infected Patients With Neutropenia Secondary to Azidothymidine
3. A Phase I /II Study of the Protease Inhibitor Indinavir (MK-0639) in Children with HIV Infection
4. A Study of Viracept in AIDS Patients with Mycobacterium Avium Complex Disease (MAC)
5. Clinical, Laboratory and Epidemiologic Pilot Studies of Individuals at High Risk for Viral-Associated Cancers
Related Studies:
Other HIV Infections Clinical Trials
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Other Boston Clinical Trials
The Safety and Effectiveness of Human Monoclonal Antibody, F105, in the Treatment of HIV
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