Status:
COMPLETED
A Study of Zidovudine During Labor and Delivery in HIV-Infected Pregnant Women
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
HIV Infections
Pregnancy
Eligibility:
FEMALE
Phase:
PHASE1
Brief Summary
To obtain a pharmacokinetic profile of oral ZDV and to determine whether the oral administration of Zidovudine (ZDV) during labor and delivery will provide a similar profile to that obtained with the ...
Detailed 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 a...
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
November 1 2003
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00000862
End Date
November 1 2003
Last Update
October 28 2021
Active Locations (11)
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1
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, United States, 920930672
2
UCLA Med Ctr / Pediatric
Los Angeles, California, United States, 900951752
3
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, United States, 941430105
4
Univ of California, San Francisco
San Francisco, California, United States, 94143