Search / Trial NCT00000828

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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

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Trial Information

Current as of April 22, 2024

Completed

Keywords

Pregnancy Pregnancy Complications, Infectious Acquired Immunodeficiency Syndrome Aids Related Complex Zidovudine Drug Resistance, Microbial Disease Transmission, Vertical

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 m...

Gender

Female

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.

Attachments

readout_NCT00000828_2024-04-22.pdf

4.5 MB

NCT00000828_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Los Angeles, California, United States

Springfield, Massachusetts, United States

Bronx, New York, United States

Birmingham, Alabama, United States

La Jolla, California, United States

Long Beach, California, United States

Los Angeles, California, United States

Los Angeles, California, United States

Washington, District Of Columbia, United States

Washington, District Of Columbia, United States

Miami, Florida, United States

Chicago, Illinois, United States

Baltimore, Maryland, United States

Boston, Massachusetts, United States

New York, New York, United States

New York, New York, United States

New York, New York, United States

New York, New York, United States

Rochester, New York, United States

Syracuse, New York, United States

Durham, North Carolina, United States

Columbus, Ohio, United States

San Juan, , Puerto Rico

Newark, New Jersey, United States

Farmington, Connecticut, United States

New Orleans, Louisiana, United States

New Orleans, Louisiana, United States

Boston, Massachusetts, United States

Hartford, Connecticut, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
41
4 stars
6
3 stars
2
2 stars
0
1 stars
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Leslie Alexander
20 September 2023

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Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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