Study of Perinatal Transmission of Zidovudine-Resistant HIV Among Pregnant Women Treated With Zidovudine
To identify patterns of zidovudine ( AZT ) susceptibility among mother/infant pairs with perinatal HIV transmission.
Most HIV-infected infants acquire their disease via perinatal transmission. Since transmission of HIV-resistant strains to infants could alter the course of disease and response to currently recommended treatment, a study to assess the patterns of AZT susceptibility among mother/infant pairs with perinatal transmission is essential to delineate future therapeutic strategies.
연구 개요
상세 설명
Most HIV-infected infants acquire their disease via perinatal transmission. Since transmission of HIV-resistant strains to infants could alter the course of disease and response to currently recommended treatment, a study to assess the patterns of AZT susceptibility among mother/infant pairs with perinatal transmission is essential to delineate future therapeutic strategies.
HIV-infected pregnant women are enrolled at 20-36 weeks gestation. Patients have blood drawn for HIV culture at study entry and at delivery. Infants have blood drawn for HIV culture at delivery and at 1, 3, 6, and 18 months of age.
연구 유형
등록
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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Los Angeles, California, 미국, 900951752
- UCLA Med Ctr / Pediatric
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Connecticut
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Farmington, Connecticut, 미국, 06032
- Univ of Connecticut / Farmington
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Hartford, Connecticut, 미국, 06106
- Connecticut Children's Med Ctr - Pediatric
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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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Miami, Florida, 미국, 33161
- Univ of Miami (Pediatric)
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Illinois
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Chicago, Illinois, 미국, 606371470
- Univ of Chicago Children's Hosp
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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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New Orleans, Louisiana, 미국, 70112
- Univ Hosp
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Maryland
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Baltimore, Maryland, 미국, 212874933
- Johns Hopkins Hosp - Pediatric
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Massachusetts
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Boston, Massachusetts, 미국, 02115
- Brigham and Women's Hosp
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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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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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Bronx, New York, 미국, 10457
- Bronx Lebanon Hosp Ctr
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New York, New York, 미국, 10016
- Bellevue Hosp / New York Univ Med 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, 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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Ohio
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Columbus, Ohio, 미국, 432052696
- Columbus Children's Hosp
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San Juan, 푸에르토 리코, 009367344
- San Juan City Hosp
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria
Prior Medication: Required:
- At least 6 months of prior AZT, including continuously during the current pregnancy.
Patients must have:
- HIV seropositivity.
- CD4 count <= 300 cells/mm3.
- Gestational age of 20-36 weeks, with intention to carry pregnancy to term.
- At least 6 months of prior AZT therapy, including continuous AZT therapy during the current pregnancy.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
- Evidence of pre-existing fetal anomalies that would preclude survival to the end of the study, such as anencephaly, renal agenesis, or Potter's syndrome.
Concurrent Medication:
Excluded:
- Antiretrovirals other than AZT.
공부 계획
연구는 어떻게 설계됩니까?
공동 작업자 및 조사자
수사관
- 연구 의자: Bardeguez AD
- 연구 의자: Pitt J
간행물 및 유용한 링크
일반 간행물
- Garcia PM, Kalish LA, Pitt J, Minkoff H, Quinn TC, Burchett SK, Kornegay J, Jackson B, Moye J, Hanson C, Zorrilla C, Lew JF. Maternal levels of plasma human immunodeficiency virus type 1 RNA and the risk of perinatal transmission. Women and Infants Transmission Study Group. N Engl J Med. 1999 Aug 5;341(6):394-402. doi: 10.1056/NEJM199908053410602.
- Bardeguez AD. Management of HIV infection for the childbearing age woman. Clin Obstet Gynecol. 1996 Jun;39(2):344-60. doi: 10.1097/00003081-199606000-00009. No abstract available.
- Bardeguez AD, Taylor U, Appuzio J, Leus C, Lister M, Denny T, Palumbo P, Connor E. Characteristics of pregnant women infected with human immunodeficiency virus 1: Newark perinatal transmission study. Int Conf AIDS. 1991 Jun 16-21;7(2):193 (abstract no WB2044)
- Welles SL, Pitt J, Colgrove R, McIntosh K, Chung PH, Colson A, Lockman S, Fowler MG, Hanson C, Landesman S, Moye J, Rich KC, Zorrilla C, Japour AJ. HIV-1 genotypic zidovudine drug resistance and the risk of maternal--infant transmission in the women and infants transmission study. The Women and Infants Transmission Study Group. AIDS. 2000 Feb 18;14(3):263-71. doi: 10.1097/00002030-200002180-00008.
연구 기록 날짜
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- ACTG 255
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