A Study of Zidovudine in HIV-Infected Pregnant Women and Their Children

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

Keywords

ClinConnect Summary

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 safet...

Gender

ALL

Eligibility criteria

• • 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 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.
• Patients may not have any of the following diseases or symptoms:
• * Obstetrical complications:
• • Poor obstetrical history including but not limited to recurrent spontaneous abortions, previous preterm or low-birth-weight infant, congenital anomalies (past or present pregnancy), premature rupture of membranes, multiple gestation, intrauterine fetal death (this pregnancy), and placenta previa or abruptio (this pregnancy).
• * Medical complications:
• • Conditions including but not limited to insulin-dependent diabetes mellitus (IDDM), hypertensive disorders which include preeclampsia, eclampsia, chronic hypertension, cardiovascular disease including rheumatic or congenital heart disease, collagen vascular disease, endocarditis, and renal disease.
• • Hematologic complications.
• • Neurologic complications.
• • Pulmonary complications.
• • History of illicit drug use during this pregnancy.
• • Note: This exclusion applies only to the first six or more women to enter this study who do not have a history of intravenous drug use.
• Four or more patients:
• • Intravenous drug use, if enrolled in a methadone maintenance program.

Trial Officials