A Study of Zidovudine in HIV-Infected Pregnant Women and Their Children (NCT00001106) | Clinical Trial Compass
CompletedPhase 1
A Study of Zidovudine in HIV-Infected Pregnant Women and Their Children
United States40 participants
Plain-language 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.
Who can participate
Age range
1 Day – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
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.
Exclusion Criteria
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 gestat…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Trial details
NCT IDNCT00001106
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)