Safety and Effectiveness of CD4-IgG2 in HIV-Positive Children
Phase I/II Trial of CD4-IgG2 in HIV-Infected Children
CD4-IgG2 is a special man-made protein that was built to block the entrance of HIV into CD4 cells (cells of the immune system that fight infection). The purpose of this study is to see if giving CD4-IgG2 to HIV-infected children is safe and effective.
HIV attaches to CD4 cells and enters them. Inside, HIV makes copies of itself that will help the virus invade the body. CD4 cells are killed or disabled during this process of HIV replication. Decreases in CD4 cells lead to a weakened immune system. When CD4 cell counts become very low, the body is unable to defend itself, and HIV infection develops into AIDS. The protein used in this study, CD4-IgG2, may be able to attach to HIV and inactivate it so that it cannot enter CD4 cells. This is an early study to examine CD4-IgG2 as a possible treatment for HIV in children.
調査の概要
詳細な説明
Since CD4 is the high-affinity receptor for HIV-1, molecules such as CD4-IgG2, which incorporate the gp120 binding region of CD4, have the potential to bind and neutralize all strains of the virus. [AS PER AMENDMENT 4/25/00: Study results have demonstrated that the product is safe in children, well tolerated, and may have antiviral properties. With these encouraging results in hand, an extra cohort has been added using twice the dose of rCD4-IgG2 as in Cohort I.]
The study is conducted in two parts. In Part 1 patients receive a single dose of CD4-IgG2 intravenously at 1 of 4 dose levels. A minimum of 3 patients are treated at a given dose level. If none of these 3 patients experience Grade 3 or 4 toxicity, patients are escalated to the next dose level. If any of these 3 patients have life-threatening toxicities or if more than 1 of these 3 patients experience non-life-threatening Grade 3 or 4 toxicities, escalation stops and the prior dose (if any) is considered the maximum tolerated dose (MTD). If 1 of these 3 patients experiences non-life-threatening Grade 3 or 4 toxicities, 3 additional patients are treated at this dose level. If 1 or more of these 3 additional patients has Grade 3 or 4 toxicity, escalation stops. If none of these 3 additional patients has Grade 3 or 4 toxicity, patients are escalated to the next dose level.
Part 2 provides additional data on the safety, toxicity and pharmacokinetics of CD4-IgG2 when given in multiple doses. Patients receive the highest safe dose (MTD) as established in Part 1. Treatment is given intravenously once weekly at Weeks 0, 1, 2, and 3. If insufficient activity is seen at this dose level, 6 additional patients will be enrolled at a higher dose level. Patients who participate in Part 1 may enroll in Part 2 provided they are followed for at least 3 months and meet inclusion criteria for Part 2. If any patient experiences a life-threatening condition due to CD4-IgG2, the study will stop. [AS PER AMENDMENT 4/25/00: Cohort II receives twice the dose of Cohort I intravenously once weekly at Weeks 0, 1, 2 and 3. Pharmacokinetic samples are obtained at pre-dose and 1 hour after the doses are administered at Weeks 0, 1, and 2; and pre-dose, 1 hour, 24 hours, and Days 3, 7, and 14 after the dose are administered at Week 3. An overnight stay in the hospital is recommended for the first 24 hours. At Weeks 0, 1, 2, and 3, virology testing including HIV-1 RNA is performed with each infusion of CD4-IgG. Follow-up monitoring of patients is done once a month for 4 months for patients in Cohort II.]
研究の種類
入学
段階
- フェーズ 1
連絡先と場所
研究場所
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California
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Long Beach、California、アメリカ、90801
- Long Beach Memorial Med. Ctr., Miller Children's Hosp.
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Los Angeles、California、アメリカ、900276016
- Childrens Hosp. LA - Dept. of Ped., Div. of Clinical Immunology & Allergy
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Los Angeles、California、アメリカ、90090-1752
- UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
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Orange、California、アメリカ、92868
- Children's Hosp. of Orange County
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San Francisco、California、アメリカ、941430105
- UCSF Pediatric AIDS CRS
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District of Columbia
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Washington、District of Columbia、アメリカ、20010-2970
- Children's National Med. Ctr. Washington DC NICHD CRS
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Florida
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Jacksonville、Florida、アメリカ、32209
- Univ. of Florida Jacksonville NICHD CRS
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Texas
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Houston、Texas、アメリカ、77030
- Texas Children's Hosp. CRS
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria
Children may be eligible for this study if they:
- Are HIV-positive.
- Are 2-12 years old and have consent of parent or legal guardian.
- Have HIV levels of 10,000 copies/ml or more on at least 2 occasions and 30 days apart (Part 2 only).
- Have been on stable, unchanged anti-HIV therapy for 3 months before study entry.
Exclusion Criteria
Children will not be eligible for this study if they:
- Have an active opportunistic (HIV-related) infection.
- Are pregnant.
- Are taking certain medications.
- Have received any vaccinations within 30 days prior to study entry.
- Have a heart problem that would affect their ability to take part in the study. (This study has been changed. The original version didn't mention heart problems.)
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- マスキング：なし（オープンラベル）
協力者と研究者
捜査官
- スタディチェア：Stuart Starr
- スタディチェア：William Shearer
出版物と役立つリンク
研究記録日
主要日程の研究
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- PACTG 351
- 10699 (その他の識別子：CTEP)
- ACTG 351
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。