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Study of Perinatal Transmission of Zidovudine-Resistant HIV Among Pregnant Women Treated With Zidovudine

Primary Purpose

HIV Infections, Pregnancy

Status
Completed
Phase
Locations
International
Study Type
Observational
Intervention
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for HIV Infections focused on measuring Pregnancy, Pregnancy Complications, Infectious, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine, Drug Resistance, Microbial, Disease Transmission, Vertical

Eligibility Criteria

13 Years - 60 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Univ of Alabama at Birmingham Schl of Med / Pediatrics
  • UCSD Med Ctr / Pediatrics / Clinical Sciences
  • Long Beach Memorial (Pediatric)
  • Los Angeles County - USC Med Ctr
  • UCLA Med Ctr / Pediatric
  • Harbor - UCLA Med Ctr / UCLA School of Medicine
  • Univ of Connecticut / Farmington
  • Connecticut Children's Med Ctr - Pediatric
  • Children's Hosp of Washington DC
  • Howard Univ Hosp
  • Univ of Miami (Pediatric)
  • Univ of Chicago Children's Hosp
  • Tulane Univ / Charity Hosp of New Orleans
  • Univ Hosp
  • Johns Hopkins Hosp - Pediatric
  • Children's Hosp of Boston
  • Brigham and Women's Hosp
  • Baystate Med Ctr of Springfield
  • Univ of Medicine & Dentistry of New Jersey / Univ Hosp
  • Bronx Lebanon Hosp Ctr
  • Bellevue Hosp / New York Univ Med Ctr
  • Mount Sinai Med Ctr / Pediatrics
  • Columbia Presbyterian Med Ctr
  • Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
  • Univ of Rochester Medical Center
  • SUNY Health Sciences Ctr at Syracuse / Pediatrics
  • Duke Univ Med Ctr
  • Columbus Children's Hosp
  • San Juan City Hosp

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00000828
Brief Title
Study of Perinatal Transmission of Zidovudine-Resistant HIV Among Pregnant Women Treated With Zidovudine
Official Title
Study of Perinatal Transmission of Zidovudine-Resistant HIV Among Pregnant Women Treated With Zidovudine
Study Type
Observational

2. Study Status

Record Verification Date
October 1997
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Pregnancy
Keywords
Pregnancy, Pregnancy Complications, Infectious, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine, Drug Resistance, Microbial, Disease Transmission, Vertical

7. Study Design

Enrollment
250 (false)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bardeguez AD
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Pitt J
Official's Role
Study Chair
Facility Information:
Facility Name
Univ of Alabama at Birmingham Schl of Med / Pediatrics
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
UCSD Med Ctr / Pediatrics / Clinical Sciences
City
La Jolla
State/Province
California
ZIP/Postal Code
920930672
Country
United States
Facility Name
Long Beach Memorial (Pediatric)
City
Long Beach
State/Province
California
ZIP/Postal Code
90801
Country
United States
Facility Name
Los Angeles County - USC Med Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
UCLA Med Ctr / Pediatric
City
Los Angeles
State/Province
California
ZIP/Postal Code
900951752
Country
United States
Facility Name
Harbor - UCLA Med Ctr / UCLA School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
905022004
Country
United States
Facility Name
Univ of Connecticut / Farmington
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06032
Country
United States
Facility Name
Connecticut Children's Med Ctr - Pediatric
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
Children's Hosp of Washington DC
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
200102916
Country
United States
Facility Name
Howard Univ Hosp
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20060
Country
United States
Facility Name
Univ of Miami (Pediatric)
City
Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Univ of Chicago Children's Hosp
City
Chicago
State/Province
Illinois
ZIP/Postal Code
606371470
Country
United States
Facility Name
Tulane Univ / Charity Hosp of New Orleans
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
701122699
Country
United States
Facility Name
Univ Hosp
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Johns Hopkins Hosp - Pediatric
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
212874933
Country
United States
Facility Name
Children's Hosp of Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
021155724
Country
United States
Facility Name
Brigham and Women's Hosp
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Baystate Med Ctr of Springfield
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Facility Name
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
City
Newark
State/Province
New Jersey
ZIP/Postal Code
071032714
Country
United States
Facility Name
Bronx Lebanon Hosp Ctr
City
Bronx
State/Province
New York
ZIP/Postal Code
10457
Country
United States
Facility Name
Bellevue Hosp / New York Univ Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Mount Sinai Med Ctr / Pediatrics
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia Presbyterian Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Univ of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
SUNY Health Sciences Ctr at Syracuse / Pediatrics
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Duke Univ Med Ctr
City
Durham
State/Province
North Carolina
ZIP/Postal Code
277103499
Country
United States
Facility Name
Columbus Children's Hosp
City
Columbus
State/Province
Ohio
ZIP/Postal Code
432052696
Country
United States
Facility Name
San Juan City Hosp
City
San Juan
ZIP/Postal Code
009367344
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
8734001
Citation
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.
Results Reference
background
Citation
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)
Results Reference
background
Citation
Japour AJ, Welles S, McIntosh K, Colson A, Chung P, Lockman S, Davenny K, Fowler MG, Hansen IC, Kalish L, Moye J, Rick K, Zorilla C, Pitt J. ZDV resistance (ZDVR) mutations in ZDV exposed mother infant pairs: preliminary findings from the women and infants transmission study (WITS). Int Conf AIDS. 1996 Jul 7-12;11(1):370 (abstract no TuC2606)
Results Reference
background
PubMed Identifier
10432324
Citation
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.
Results Reference
background

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Study of Perinatal Transmission of Zidovudine-Resistant HIV Among Pregnant Women Treated With Zidovudine

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