A Study to Compare Two Anti-HIV Combination Therapies Each Containing Saquinavir in HIV-Positive Children
A Randomized Trial of Two Saquinavir-Containing Combination Treatment Regimens in Children With HIV Infection
The purpose of this study is to determine the safety and effectiveness of a soft-gel capsule formulation of saquinavir (SQV-SGC), a protease inhibitor, when given in combination with other anti-HIV drugs.
SQV-SGC has been tested in adults for the treatment of HIV infection, but more information is still needed about SQV-SGC in children. Recent studies suggest that this soft-gel capsule form may be safer and more effective than other protease inhibitors.
연구 개요
상세 설명
Clinical trials in adults and children suggest that SQV-SGC has advantages over other protease inhibitors in terms of tolerability, safety, and effectiveness in patients who have failed therapy with other protease inhibitors. [AS PER AMENDMENT 11/24/99: Pharmacokinetic data from this study demonstrate lower than expected plasma SQV exposures, particularly in Arm 1. Based on these data, patients in the study will be offered the opportunity to adjust their doses. Ritonavir added to the Arm 1 regimen is expected to significantly increase SQV-SGC plasma levels and allow twice-daily dosing for SQV-SGC.]
Patients are randomized to one of two study arms. Patients in Arm 1 receive SQV-SGC plus two [AS PER AMENDMENT 11/24/99: one or two] NRTIs of choice. Patients in Arm 2 receive SQV-SGC plus NFV plus one or two NRTIs of choice. All participants are evaluated by physical examinations and laboratory tests during the study and are followed for incidence of death, cancer, or fetal abnormality. NRTIs are not provided as part of this study. [AS PER AMENDMENT 11/24/99: This study is closed to accrual. All subjects on follow-up (Cohort 1) are given the option of either discontinuing participation in ACTG 397 or participating in the next phase of the study (version 2.0). Those electing to continue participation constitute Cohort 1A. The adjusted Arm 1 regimen consists of SQV-SGC plus ritonavir plus one or two NRTIs. Ritonavir is not provided as part of this study. The Arm 2 regimen study drugs have not changed but the maximum allowable dose of SQV-SGC has increased from 1,200 mg twice-daily to 1,600 mg twice-daily. Participants continue to be followed with physical examinations and laboratory evaluations that include an intensive pharmacokinetics study on Day 14 of the new regimen.]
연구 유형
등록
단계
- 2 단계
연락처 및 위치
연구 장소
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Alabama
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Birmingham, Alabama, 미국, 35233
- Univ of Alabama at Birmingham - Pediatric
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Birmingham, Alabama, 미국, 352330011
- Univ of Alabama at Birmingham / Childrens Hosp of AL
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California
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Long Beach, California, 미국, 90801
- Long Beach Memorial (Pediatric)
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Los Angeles, California, 미국, 90033
- Los Angeles County - USC Med Ctr
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Oakland, California, 미국, 946091809
- Children's Hosp of Oakland
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San Francisco, California, 미국, 941430105
- UCSF / Moffitt Hosp - Pediatric
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Connecticut
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New Haven, Connecticut, 미국, 06504
- Yale Univ Med School
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District of Columbia
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Washington, District of Columbia, 미국, 20060
- Howard Univ Hosp
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Florida
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Miami, Florida, 미국, 33161
- Univ of Miami (Pediatric)
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Riviera Beach, Florida, 미국, 33404
- Palm Beach County Health Dept
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Georgia
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Atlanta, Georgia, 미국, 30306
- Emory Univ Hosp / Pediatrics
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Illinois
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Chicago, Illinois, 미국, 60612
- Cook County Hosp
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Chicago, Illinois, 미국, 606143394
- Chicago Children's Memorial Hosp
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Chicago, Illinois, 미국, 60612
- Univ of Illinois College of Medicine / Pediatrics
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Louisiana
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New Orleans, Louisiana, 미국, 701122699
- Tulane Univ / Charity Hosp of New Orleans
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Maryland
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Baltimore, Maryland, 미국, 21201
- Univ of Maryland at Baltimore / Univ Med Ctr
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Massachusetts
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Boston, Massachusetts, 미국, 021155724
- Children's Hosp of Boston
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Springfield, Massachusetts, 미국, 01199
- Baystate Med Ctr of Springfield
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Mississippi
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Jackson, Mississippi, 미국, 39213
- Univ of Mississippi Med Ctr
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New Jersey
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Newark, New Jersey, 미국, 071032714
- Univ of Medicine & Dentistry of New Jersey / Univ Hosp
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New York
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Albany, New York, 미국, 12208
- Children's Hosp at Albany Med Ctr
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Bronx, New York, 미국, 10461
- Bronx Municipal Hosp Ctr/Jacobi Med Ctr
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Bronx, New York, 미국, 10457
- Bronx Lebanon Hosp Ctr
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Great Neck, New York, 미국, 11021
- North Shore Univ Hosp
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New York, New York, 미국, 10021
- Cornell Univ Med College
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New York, New York, 미국, 10032
- Columbia Presbyterian Med Ctr
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New York, New York, 미국, 10032
- Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
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New York, New York, 미국, 10037
- Harlem Hosp Ctr
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Stony Brook, New York, 미국, 117948111
- State Univ of New York at Stony Brook
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 191341095
- Saint Christopher's Hosp for Children
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South Carolina
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Charleston, South Carolina, 미국, 294253312
- Med Univ of South Carolina
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Virginia
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Richmond, Virginia, 미국, 23219
- Med College of Virginia
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Washington
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Seattle, Washington, 미국, 981050371
- Children's Hospital & Medical Center / Seattle ACTU
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Bayamon, 푸에르토 리코, 00956
- Ramon Ruiz Arnau Univ Hosp / Pediatrics
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San Juan, 푸에르토 리코, 009367344
- San Juan City Hosp
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San Juan, 푸에르토 리코, 009365067
- Univ of Puerto Rico / Univ Children's Hosp AIDS
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria
Your child may be eligible for this study if he or she:
- Is HIV-positive.
- Is 3 to 16 years of age (consent of parent or guardian is required).
- Has an HIV level greater than 10,000 copies/ml.
- Has never taken at least one of the following anti-HIV drugs: lamivudine, zidovudine, stavudine, or didanosine.
- Is able to swallow capsules and tablets.
Exclusion Criteria
Your child will not be eligible if he or she:
- Has cancer requiring chemotherapy.
- Has an acute opportunistic (AIDS-related) infection requiring therapy.
- Has had two or more episodes of moderate or severe diarrhea or vomiting in the 3 months prior to study entry.
- Has ever taken SQV or NFV.
- Is pregnant or breast-feeding.
- Is taking certain medications, including those that would interfere with the study drugs.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
공동 작업자 및 조사자
수사관
- 연구 의자: Courtney Fletcher
- 연구 의자: Mark Kline
간행물 및 유용한 링크
일반 간행물
- Brundage RC, Kline MW, Lindsey J, Fenton T, Fletcher CV. Pharmacokinetics of saquinavir (SQV) with nelfinavir (NFV) or ritonavir (RTV) in HIV-infected children. 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 728)
- Kline MW, Fletcher CV, Lindsey JC, Fenton T. A randomized trial of two saquinavir (SQV-SGC)-containing combination treatment regimens in HIV-infected children. 7th Conference on Retroviruses and Opportunistic Infections. 2000 Jan 30-Feb 2 [Poster 694]
- Kline MW, Fletcher CV, Lindsey JC, Fenton T. A randomized trial of combination therapy with saquinavir soft gelatin capsules (SQV) in HIV-infected children. 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 683)
- Brundage RC, Kline MW, Lindsey JC, Fenton T, Fletcher CV. Pharmacokinetics (PK) of saquinavir (SQV) and nelfinavir (NFV) in a twice-daily (BID) regimen in HIV-infected children. 7th Conference on Retroviruses and Opportunistic Infections. 2000 Jan 30-Feb 2 [Poster 718]
연구 기록 날짜
연구 주요 날짜
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- ACTG 397
- 11353 (레지스트리 식별자: DAIDS ES)
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. .