Search / Trial NCT00001106

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

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Trial Information

Current as of May 23, 2024

Completed

Keywords

Pregnancy Pregnancy Complications, Infectious Prenatal Exposure Delayed Effects Drug Evaluation Acquired Immunodeficiency Syndrome Zidovudine

Description

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.

Attachments

readout_NCT00001106_2024-05-23.pdf

4.5 MB

NCT00001106_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Seattle, Washington, United States

Los Angeles, California, United States

Miami, Florida, United States

Boston, Massachusetts, United States

New York, New York, United States

Seattle, Washington, United States

Newark, New Jersey, United States

Newark, New Jersey, United States

Los Angeles, California, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
41
4 stars
6
3 stars
2
2 stars
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1 stars
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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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