The Safety and Effectiveness of Human Monoclonal Antibody, F105, in the Treatment of HIV
A Phase I Clinical Trial to Study the Toxicity, Pharmacokinetics, and Efficacy of Human Monoclonal Antibody, F105, for Treating Human Immunodeficiency Virus Infection.
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.
研究概览
详细说明
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).
研究类型
注册
阶段
- 阶段1
联系人和位置
学习地点
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Massachusetts
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Boston、Massachusetts、美国、02215
- Beth Israel Deaconess Med. Ctr., ACTG CRS
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
合作者和调查者
调查人员
- 学习椅:Samore MH
出版物和有用的链接
研究记录日期
研究主要日期
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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