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

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000828
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: October 1997

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00000828 on ClinicalTrials.gov Archive Site
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Study of Perinatal Transmission of Zidovudine-Resistant HIV Among Pregnant Women Treated With Zidovudine
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.

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.

Observational
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  • HIV Infections
  • Pregnancy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
250
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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.
Female
13 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00000828
ACTG 255
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National Institute of Allergy and Infectious Diseases (NIAID)
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Study Chair: Bardeguez AD
Study Chair: Pitt J
National Institute of Allergy and Infectious Diseases (NIAID)
October 1997

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP