A Study of Zidovudine in HIV-Infected Pregnant Women and Their Children
A Phase I Trial To Evaluate Zidovudine (ZDV) in HIV-1 Infected Pregnant Women and Their Offspring
2 other identifiers
interventional
40
1 country
9
Brief Summary
AMENDED: To evaluate the pharmacokinetics of intravenously administered AZT to HIV-1 infected pregnant women in labor; to evaluate the pharmacokinetics and urinary excretion of AZT and its metabolites in newborns of HIV-1 infected mothers who receive IV AZT only during labor; to evaluate the safety of IV AZT administered by continuous infusion to HIV-1 infected laboring women and their infants. Original design: To determine the distribution and elimination of zidovudine (AZT) in the body as well as its safety in the treatment of pregnant women and their unborn children. The information derived from this study is required in order to design a future study that will assess the efficacy of AZT in reducing the transmission rate of HIV-1 from seropositive women to their fetus by treating them during the third trimester of pregnancy. An estimated 30 percent to 40 percent infected pregnant women risk transmission of HIV-1 to their infants, whether they be symptomatic or asymptomatic. Zidovudine (AZT) has previously demonstrated its effectiveness as a potent inhibitor of HIV replication in vitro and in adult patients; benefits of treatment include decreased mortality rate, decreased incidence of opportunistic infections, and increased number of CD4 cells. Phase I AZT studies in children, however, have resulted in uncontrolled information regarding clinical efficacy. The present study, therefore, will investigate the safety and pharmacokinetics of intravenous (IV) and oral AZT administration to HIV-1 infected pregnant women in the 3rd trimester, as well as the safety and efficacy of such treatment in their newborns. It is hoped that the results will be instrumental in designing future studies to assess the efficacy of AZT in reducing the transmission risk of HIV-1.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 hiv-infections
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Completion
Last participant's last visit for all outcomes
March 1, 1994
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedNovember 1, 2021
October 1, 2021
November 2, 1999
October 28, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Concurrent Medication:
- Allowed:
- In one group of four or more patients, methadone maintenance treatment.
- Acetaminophen for periods less than 72 hours.
- Supportive therapy including blood and blood products, vaginal creams, antiemetics, antidiarrheals, and cough medicines as deemed necessary by the responsible investigator.
- Iron, multivitamins, and short course of treatment for correctable medical problems, such as urinary tract infection.
- Concurrent Treatment:
- Allowed:
- Blood and blood products as supportive therapy.
- Patients must have HIV-1 infection and be in the third trimester of pregnancy. Additional patients will also be receiving methadone maintenance therapy for intravenous drug use.
You may not qualify if:
- Concurrent Medication:
- Excluded:
- Systemic medications during this pregnancy.
- Acetaminophen for periods more than 72 hours.
- Patients will be excluded from the study for the following reasons:
- Complications of pregnancy.
- History of poor medical compliance related to factors other than accessibility of care.
- Insistence on breast-feeding during the first 24 hours of the birth of the child.
- Evidence of preexisting fetal anomalies at = or \> 20 weeks gestation as noted by an abnormal level 2 sonogram prior to study entry.
- Evidence of fetal intolerance of the intrauterine environment including intrauterine growth retardation, oligohydramnios, polyhydramnios, biophysical profile equal to or less than 6 for fetus with a gestational age \> 32 weeks, congenital malformation, fetal hydrous or ascites.
- Previous systemic infection including influenza during this pregnancy.
- Malabsorption syndrome and/or history of frequent diarrhea that might interfere with absorption of oral zidovudine (AZT).
- Prior Medication:
- Excluded:
- Antivirals and other systemic medications during this pregnancy.
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Kaiser - Edgemont Street / UCLA Med Ctr
Los Angeles, California, 900951752, United States
UCLA Med Ctr / Pediatric
Los Angeles, California, 900951752, United States
Univ of Miami (Pediatric)
Miami, Florida, 33161, United States
Boston City Hosp / Pediatrics
Boston, Massachusetts, 02118, United States
UMDNJ - New Jersy Med School
Newark, New Jersey, 071032714, United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, 071032714, United States
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016, United States
Children's Hosp of Seattle
Seattle, Washington, 98105, United States
Univ of Washington
Seattle, Washington, 981224304, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
O'Sullivan MJ
- STUDY CHAIR
Parks W
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Completion
March 1, 1994
Last Updated
November 1, 2021
Record last verified: 2021-10