A Study of Zidovudine During Labor and Delivery in HIV-Infected Pregnant Women
NCT ID: NCT00000862
Last Updated: 2021-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
36 participants
INTERVENTIONAL
2003-11-30
Brief Summary
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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.
Detailed Description
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Cohort 1: Women in active labor receive 3 doses of oral ZDV 3 hours apart followed by PK sampling. After PK sampling post 3rd oral dose, or at 8 cm dilation (whichever comes first), women receive IV ZDV until delivery. The cord blood will be analyzed for serum ZDV PK levels and the infant's infection status will be determined. If the dose of ZDV is adequate to achieve targeted maternal serum drug levels in Cohort 1 and if oral dosing is tolerated in this cohort, Cohort 2 will begin enrollment. \[AS PER AMENDMENT 08/03/01: Cohort 1 has been completed and only Cohort 2 is open for enrollment.\] Cohort 2: \[AS PER AMENDMENT 08/03/01: Women in active labor receive initial loading dose of oral ZDV, then another dose of oral ZDV 3 hours later, both doses followed by PK sampling. After PK sampling post second oral dose, or at 8 cm dilation (whichever comes first), woman receives IV ZDV until delivery. The cord blood will not be analyzed for serum ZDV PK levels and the infant's infection status will be determined.\]
Conditions
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Keywords
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Study Design
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PARALLEL
TREATMENT
Interventions
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Zidovudine
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
FEMALE
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Mark Mirochnick
Role: STUDY_CHAIR
Pamela Boyer
Role: STUDY_CHAIR
Locations
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UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, United States
UCLA Med Ctr / Pediatric
Los Angeles, California, United States
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, United States
Univ of California, San Francisco
San Francisco, California, United States
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, United States
Univ of Miami / Jackson Memorial Hosp
Miami, Florida, United States
Univ of Miami (Pediatric)
Miami, Florida, United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, United States
Saint Jude Children's Research Hosp of Memphis
Memphis, Tennessee, United States
Children's Hosp of the King's Daughters
Norfolk, Virginia, United States
San Juan City Hosp
San Juan, , Puerto Rico
Countries
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Other Identifiers
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11298
Identifier Type: REGISTRY
Identifier Source: secondary_id
PACTG 324
Identifier Type: -
Identifier Source: secondary_id
ACTG 324
Identifier Type: -
Identifier Source: org_study_id