A Phase I Study of the Safety and Pharmacokinetics of Recombinant CD4 Immunoglobulin G (rCD4-IgG) in Infants and Children With Documented HIV-1 Infection
To determine the safety profile, assess pharmacokinetic properties (blood levels), and obtain preliminary indication of the antiviral and immunologic effects of recombinant CD4 immunoglobulin G (CD4-IgG).
CD4-IgG may be effective in blocking HIV transmission and spread, that is, CD4-IgG has antiviral effects. Studies done in adult patients with AIDS and AIDS related complex (ARC) have shown that rCD4 can be safely administered by intravenous bolus, intramuscular or subcutaneous injection. No serious or dose-limiting, drug-related toxicities have been observed to date.
研究概览
详细说明
CD4-IgG may be effective in blocking HIV transmission and spread, that is, CD4-IgG has antiviral effects. Studies done in adult patients with AIDS and AIDS related complex (ARC) have shown that rCD4 can be safely administered by intravenous bolus, intramuscular or subcutaneous injection. No serious or dose-limiting, drug-related toxicities have been observed to date.
Patients receive one intravenous injection the first week, followed by a 6 day washout period and then intravenous injections on a twice weekly basis from week 2 to week 12. The dose per injection may vary. The study evaluates 2 groups: (1) Children 3 months to 5 years of age; (2) Infants 0-3 months of age.
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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California
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San Diego、California、美国、92103
- UCSD Treatment Ctr
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Florida
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Miami、Florida、美国、33136
- Univ of Miami School of Medicine
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Illinois
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Chicago、Illinois、美国、60612
- Cook County Hosp
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Louisiana
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New Orleans、Louisiana、美国、70112
- Tulane Univ Med School
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New York
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Great Neck、New York、美国、11021
- North Shore Univ Hosp
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New York、New York、美国、10032
- Columbia Univ Babies' Hosp
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Texas
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Houston、Texas、美国、77030
- Texas Children's Hosp / Baylor Univ
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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
Patients must have the following:
- HIV-1 infection, or if less than 15 months old, born to mother with HIV-1 infection.
- Legally qualified guardian with the ability to sign a written, informed consent form.
- Willingness to abstain from all other experimental therapy for HIV-1 infection during the first 12 weeks of the study period.
- Anticipated life expectancy of at least 3 months.
Prior Medication:
Allowed:
- Prophylactic anti-Pneumocystis carinii pneumonia (PCP) or antifungal therapy.
- Gamma globulin as prophylaxis for measles and varicella.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
- Past or present history of neurological abnormalities including withdrawal syndrome or seizures.
- Past or present history of any serious active opportunistic infection including Pneumocystis carinii pneumonia (PCP).
- Echocardiogram values > 2 standard deviations from normal.
- Hematologic, renal, or hepatic insufficiency.
Concurrent Medication:
Excluded:
- Zidovudine (AZT).
- Intravenous gamma globulin (IVIG) except as prophylaxis for measles and varicella.
- Cancer chemotherapy.
- Corticosteroids.
- Other known immunomodulatory agents.
- Other experimental therapy not specifically allowed.
Patients with the following are excluded:
- Hematologic, renal, or hepatic insufficiency.
- Past or present history of any serious active opportunistic infection.
Prior Medication:
Excluded for a minimum of 3 weeks prior to study entry:
- Zidovudine (AZT).
- Intravenous gamma globulin (IVIG).
- Cancer chemotherapy.
- Immunomodulatory agents.
- Acyclovir and other experimental therapy.
Risk Behavior:
Excluded:
- Patients born to substance abusing mothers (including alcohol) during the pregnancy.
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
合作者
调查人员
- 学习椅:W Shearer
- 学习椅:R Yogev
出版物和有用的链接
一般刊物
- Weintrub P, Yogev R, Conner E, Wilfert K, Mordenti J, Ammann AJ. Safety and pharmacokinetics of recombinant CD4 in children with HIV infection. Int Conf AIDS. 1990 Jun 20-23;6(2):95 (abstract no FB23)
- Shearer WT, Israel RJ, Starr S, Fletcher CV, Wara D, Rathore M, Church J, DeVille J, Fenton T, Graham B, Samson P, Staprans S, McNamara J, Moye J, Maddon PJ, Olson WC. Recombinant CD4-IgG2 in human immunodeficiency virus type 1-infected children: phase 1/2 study. The Pediatric AIDS Clinical Trials Group Protocol 351 Study Team. J Infect Dis. 2000 Dec;182(6):1774-9. doi: 10.1086/317622. Epub 2000 Oct 27.
研究记录日期
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 (估计)
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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Hospital Clinic of Barcelona完全的
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Rajavithi Hospital未知研究在放疗前和放疗最后一周接受放疗的 HIV 癌症患者的免疫状态 | 研究在放疗前和放疗最后一周接受放疗的 HIV 癌症患者的 HIV 病毒载量泰国
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National Institute of Allergy and Infectious Diseases...完全的HIV-1 感染 | HIV抗体 | 中和抗体 | 病毒载量 | 单克隆抗体美国
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AIDS Healthcare FoundationUniversity of California, Los Angeles完全的
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CD4-IgG的临床试验
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Genentech, Inc.完全的
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