A Study of Didanosine Use Alone or in Combination With Zidovudine in Infants Exposed to or Infected With HIV
A Phase I Evaluation of the Safety and Toxicity of Zidovudine and Didanosine in Combination in HIV-Infected or Exposed Infants and a Phase II Study of the Effect of Didanosine vs. Combination Therapy With Zidovudine and Didanosine on HIV-1 RNA in Infants With HIV Infection
To determine the pharmacokinetics, safety, and efficacy of didanosine (ddI) alone or in combination with zidovudine (AZT) in HIV-infected infants.
PER AMENDMENT 4/8/97: Part A study objectives are completed. Part B objectives: To assess the safety, toxicity, and tolerability and to compare anti-HIV activity, as measured by change in log10 RNA, of the two study arms.
Early treatment of HIV-infected infants with antiretroviral agents may prevent the early and rapid decline of CD4 count and immunologic function. Combination therapy may be preferred over monotherapy, since resistance to a single agent can develop rapidly. Currently, there is little information on ddI monotherapy in young infants less than 90 days and no information on the use of combination therapy in this population.
연구 개요
상세 설명
Early treatment of HIV-infected infants with antiretroviral agents may prevent the early and rapid decline of CD4 count and immunologic function. Combination therapy may be preferred over monotherapy, since resistance to a single agent can develop rapidly. Currently, there is little information on ddI monotherapy in young infants less than 90 days and no information on the use of combination therapy in this population.
In Part A, a cohort of patients younger than 28 days (was less than 120 days; amended 6/20/95) of age receives open-label ddI monotherapy for 1 week before initiation of AZT/ddI combination therapy. After pharmacokinetic data are obtained, an additional cohort of patients receives ddI at a higher dose. An age-adjusted dose for ddI is determined for use in Part B. (NOTE: As of 2/13/95, Part A has completed accrued for infants 29 to 120 days of age.) Part B patients less than 90 days of age (was less than 180 days of age; amended 6/20/95) are randomized, on a double-blind basis, to receive ddI or AZT/ddI. All patients continue treatment until 12 months after the last patient on Part B is enrolled. PER AMENDMENT 4/8/97: Part A of this protocol is closed with accrual objectives met. Part B of the study will remain open for patient accrual until 6/2/97. Part B is designed as a 2-arm, randomized, double-blind study to assess safety, toxicity and tolerability as well as anti-HIV activity of ddI or AZT/ddI.
연구 유형
등록
단계
- 1단계
연락처 및 위치
연구 장소
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Alabama
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Birmingham, Alabama, 미국, 35294
- Univ of Alabama at Birmingham Schl of Med / Pediatrics
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California
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La Jolla, California, 미국, 920930672
- UCSD Med Ctr / Pediatrics / Clinical Sciences
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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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Los Angeles, California, 미국, 905022004
- Harbor - UCLA Med Ctr / UCLA School of Medicine
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Oakland, California, 미국, 946091809
- Children's Hosp of Oakland
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San Francisco, California, 미국, 94110
- San Francisco Gen Hosp
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San Francisco, California, 미국, 941430105
- UCSF / Moffitt Hosp - Pediatric
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Colorado
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Denver, Colorado, 미국, 802181088
- Children's Hosp of Denver
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Connecticut
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Farmington, Connecticut, 미국, 06032
- Univ of Connecticut / Farmington
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District of Columbia
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Washington, District of Columbia, 미국, 200102916
- Children's Hosp of Washington DC
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Washington, District of Columbia, 미국, 20060
- Howard Univ Hosp
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Florida
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Fort Lauderdale, Florida, 미국, 33311
- North Broward Hosp District
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Jacksonville, Florida, 미국, 32209
- Univ of Florida Health Science Ctr / Pediatrics
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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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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, 606371470
- Univ of Chicago Children's 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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Worcester, Massachusetts, 미국, 016550001
- Univ of Massachusetts Med School
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Michigan
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Detroit, Michigan, 미국, 48201
- Children's Hosp of Michigan
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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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Newark, New Jersey, 미국, 07103
- Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
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Newark, New Jersey, 미국, 071072198
- Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl
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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, 10457
- Bronx Lebanon Hosp Ctr
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New Hyde Park, New York, 미국, 11040
- Schneider Children's Hosp
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New York, New York, 미국, 10029
- Metropolitan Hosp Ctr
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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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New York, New York, 미국, 10029
- Mount Sinai Med Ctr / Pediatrics
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Rochester, New York, 미국, 14642
- Univ of Rochester Medical Center
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Syracuse, New York, 미국, 13210
- SUNY Health Sciences Ctr at Syracuse / Pediatrics
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North Carolina
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Durham, North Carolina, 미국, 277103499
- Duke Univ Med Ctr
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 191044318
- Children's Hosp of Philadelphia
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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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Norfolk, Virginia, 미국, 23507
- Children's Hosp of the King's Daughters
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Richmond, Virginia, 미국, 23219
- Med College of Virginia
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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
Concurrent Medication:
Recommended:
- PCP prophylaxis.
Allowed:
- Acetaminophen if not on a continual basis.
NOTE:
- Drugs that are metabolized by hepatic glucuronidation or that are associated with occurrence of pancreatitis are allowed but should be used with caution.
Patients must have at least one of the following:
- Documented HIV infection.
- Been born to an HIV-infected woman and receiving AZT.
PER AMENDMENT 4/8/97:
- Number 2 above no longer required with closure of Part A of study.
- Patients must have signed, informed consent of parent or legal guardian.
PER 6/20/95 AMENDMENT, patients in Part A must be less than 28 days of age and those in Part B must be less than 90 days of age.
PER 7/7/94 AMENDMENT, patients in Part A were less than 120 days of age and those in Part B were less than 180 days of age.
NOTE:
- All patients must have been more than 34 weeks gestation at birth.
Prior Medication:
Allowed:
- Prior vaccine therapy.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
- Pancreatitis.
- Clinically unstable condition.
- Current participation on a vaccine trial or, for Part A, a perinatal trial if of indeterminate infection status.
Concurrent Medication:
Excluded:
- Vaccine therapy.
Patients with the following prior condition are excluded:
- Pancreatitis at any time since birth.
Prior Medication:
Excluded in Part B patients only:
- More than 90 days of prior antiretroviral or immunomodulator therapy, exclusive of therapy received in utero.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 마스킹: 더블
공동 작업자 및 조사자
수사관
- 연구 의자: A Kovacs
- 연구 의자: R Husson
간행물 및 유용한 링크
일반 간행물
- McKinney RE Jr. Ongoing and future trials of antiretroviral therapy in the pediatric AIDS clinical trials group (PACTG). Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:173
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- ACTG 239
- 11216 (DAIDS ES Registry Number)
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. .