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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.]
연구 유형
연구 유형
등록
등록
단계
단계
- 1단계
연락처 및 위치
연구 장소
-
-
California
-
Long Beach, California, 미국, 90801
- Long Beach Memorial Med. Ctr., Miller Children's Hosp.
-
Los Angeles, California, 미국, 900276016
- Childrens Hosp. LA - Dept. of Ped., Div. of Clinical Immunology & Allergy
-
Los Angeles, California, 미국, 90090-1752
- UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
-
Orange, California, 미국, 92868
- Children's Hosp. of Orange County
-
San Francisco, California, 미국, 941430105
- UCSF Pediatric AIDS CRS
-
-
District of Columbia
-
Washington, District of Columbia, 미국, 20010-2970
- Children's National Med. Ctr. Washington DC NICHD CRS
-
-
Florida
-
Jacksonville, Florida, 미국, 32209
- Univ. of Florida Jacksonville NICHD CRS
-
-
Texas
-
Houston, Texas, 미국, 77030
- Texas Children's Hosp. CRS
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 마스킹: 없음(오픈 라벨)
공동 작업자 및 조사자
스폰서
스폰서
협력자
협력자
수사관
수사관
- 연구 의자: Stuart Starr
- 연구 의자: William Shearer
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 완료 (실제)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- PACTG 351
- 10699 (기타 식별자: CTEP)
- ACTG 351
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .