Search / Trial NCT00000862

A Study of Zidovudine During Labor and Delivery in HIV-Infected Pregnant Women

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

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Trial Information

Current as of March 05, 2024

Completed

Keywords

Pregnancy Pregnancy Complications, Infectious Administration, Oral Zidovudine Delivery Labor Anti Hiv Agents

Description

The worldwide use of constant intrapartum ZDV infusions to prevent transmission is not practical or feasible. Approximately 18% of the women in the ACTG 076 trial missed their IV ZDV infusions, even at experienced ACTG sites. There is an urgent need to establish a more practical method of delivering ZDV during labor and delivery that, at minimum, will approximate the rate of ZDV administration utilized in ACTG 082. In the future, this would enable women to start an intensive ZDV regimen during early labor, even prior to reaching the hospital. Cohort 1: Women in active labor receive 3 doses...

Gender

Female

Eligibility criteria

  • Inclusion Criteria
  • A woman may be eligible for this study if:
  • She is HIV-positive.
  • She is at least 34 weeks pregnant.
  • She has a history of at least 4 weeks of continuous oral ZDV during her current pregnancy and tolerated it well.
  • She has given consent for her newborn to participate in this study. (The father must also give consent if he is available after reasonable attempts to contact him. A woman under 18 needs the consent of a parent or legal guardian for her and her infant to participate.)
  • Exclusion Criteria
  • A woman will not be eligible for this study if:
  • She is taking part in another study of HIV treatment during pregnancy.
  • Her infant has a life-threatening illness indicated in an ultrasound.
  • Her infant does not appear to be growing normally in the womb.
  • She has a cesarean section.
  • She has abnormal blood test results.
  • She has severe nausea, vomiting, or other problems of the stomach and intestines at the time of study entry.
  • She has an active opportunistic (AIDS-related) infection or other serious infection at the time of study entry.
  • The study staff cannot find a usable vein.
  • The study doctor feels that she cannot take drugs by mouth.

Attachments

readout_NCT00000862_2024-03-05.pdf

4.5 MB

NCT00000862_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

La Jolla, California, United States

Los Angeles, California, United States

San Francisco, California, United States

Miami, Florida, United States

Memphis, Tennessee, United States

San Juan, , Puerto Rico

Newark, New Jersey, United States

Jacksonville, Florida, United States

Miami, Florida, United States

Norfolk, Virginia, United States

San Francisco, California, 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

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?

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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