Search / Trial NCT00000960

The Safety and Effectiveness of Zidovudine in HIV-Infected Pregnant Women and Their Infants

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

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Trial Information

Current as of December 09, 2023

Completed

Keywords

Pregnancy Pregnancy Complications, Infectious Prenatal Exposure Delayed Effects Administration, Oral Aids Related Complex Zidovudine

Description

No method exists to prevent transmission of HIV from an infected mother to her newborn infant. Giving an antiviral agent (such as AZT) to the mother and to the newborn could in theory decrease the risk of infection to the newborn by reducing the exposure of the fetus to maternal virus, or by preventive treatment of the fetus before exposure. Patients are enrolled during their pregnancy, between 14 and 34 weeks of gestation. They are chosen by random selection to receive AZT or placebo. Treatment continues until labor at which time they begin to receive continuous intravenous study drug. St...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed for infants:
  • Treatment for signs of drug withdrawal (e.g., phenobarbital, chlorpromazine, tincture of opium, paregoric, or Valium).
  • Treatment for nonserious conditions (e.g., syphilis treatment, hepatitis B vaccine).
  • All essential supportive treatment for conditions that are nonlife threatening as deemed by the on-site pediatrician.
  • Acetaminophen.
  • Standard immunizations.
  • Allowed for women:
  • All medications/treatments as required for normal OB care of HIV+ women, except as noted under exclusions.
  • Pneumocystis prophylaxis as indicated.
  • Topical steroids. Parenteral and oral steroids for 6 or fewer days.
  • Concurrent Treatment:
  • Allowed for pregnant woman:
  • Blood transfusion for anemia (hemoglobin less than 7 g/dl).
  • Allowed for infant:
  • - Blood transfusions for anemia except if attributed to study drug.
  • -
  • Patients must:
  • Have HIV infection.
  • Intend to carry pregnancy to term.
  • Be willing to be followed by a participating ACTG center for duration of the study.
  • Be able to provide informed consent (if available, father of the fetus must also provide informed consent).
  • Infants may enroll simultaneously in other pediatric protocols after completing the initial 6 weeks of study treatment.
  • Inclusion age for women is 13 years old or more or IRB local age of consent.
  • Inclusion age for infants is 0 to 20 months.
  • Exclusion Criteria
  • Co-existing Condition:
  • Infants with the following conditions or symptoms are excluded:
  • Requiring treatment for hyperbilirubinemia (except phototherapy).
  • Concurrent Medication:
  • Excluded:
  • Infants:
  • Antiretroviral drugs or vaccines.
  • Excluded during current pregnancy:
  • Zidovudine (AZT).
  • Other antiretroviral agents (e.g., rCD4, CD4-IgG, d4T, didanosine (ddI), dideoxycytidine (ddC)), passive immunotherapy (e.g., HIVIG), anti-HIV vaccines, cytolytic chemotherapeutic agents.
  • Corticosteroids for equal to or more than 7 days.
  • Patients with the following are excluded:
  • Evidence of preexisting fetal anomalies that may (1) result in a high probability that the fetus/infant will not survive to the end of the study period (e.g., anencephaly, renal agenesis, or Potter's syndrome); or (2) increase the fetal tissue concentration of zidovudine (AZT) or its metabolites to a toxic level (e.g., neural tube or ventral wall defects).
  • Baseline sonogram completed within 28 days prior to randomization that demonstrates 2nd trimester findings of anencephaly or oligohydramnios, or 3rd trimester findings of unexplained polyhydramnios, fetal hydrops, ascites or other evidence of preexisting in-utero anemia.
  • History of intolerance to AZT dose of 500 or less mg/day prior to this pregnancy that resulted in discontinuation of treatment for more than 4 weeks.
  • Recipient of AZT during current pregnancy for any indication or meet criteria for AZT as defined by this protocol (CD4+ cell counts less than 200 cells/mm3 or AIDS).
  • Infants not having parent/guardian available to give informed consent if necessary.
  • Prior Treatment:
  • Excluded during current pregnancy:
  • Radiation therapy.

Attachments

readout_NCT00000960_2023-12-09.pdf

4.5 MB

NCT00000960_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

Los Angeles, California, United States

Birmingham, Alabama, United States

Springfield, Massachusetts, United States

San Francisco, California, United States

Chicago, Illinois, United States

Bronx, New York, United States

Birmingham, Alabama, United States

La Jolla, California, United States

Los Angeles, California, United States

Los Angeles, California, United States

Denver, Colorado, United States

Farmington, Connecticut, United States

Washington, District Of Columbia, United States

Miami, Florida, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Baltimore, Maryland, United States

Baltimore, Maryland, United States

Boston, Massachusetts, United States

Boston, Massachusetts, United States

Worcester, Massachusetts, United States

Detroit, Michigan, United States

Newark, New Jersey, United States

Albany, New York, United States

Bronx, New York, United States

Brooklyn, New York, United States

Brooklyn, New York, United States

New York, New York, United States

New York, New York, United States

New York, New York, United States

New York, New York, United States

New York, New York, United States

Rochester, New York, United States

Stony Brook, New York, United States

Syracuse, New York, United States

Valhalla, New York, United States

Chapel Hill, North Carolina, United States

Durham, North Carolina, United States

Philadelphia, Pennsylvania, United States

Providence, Rhode Island, United States

Charleston, South Carolina, United States

Memphis, Tennessee, United States

Dallas, Texas, United States

Houston, Texas, United States

Seattle, Washington, United States

Bayamon, , Puerto Rico

San Juan, , Puerto Rico

San Juan, , Puerto Rico

San Juan, , Puerto Rico

Baltimore, Maryland, United States

Newark, New Jersey, United States

Cincinnati, Ohio, United States

Philadelphia, Pennsylvania, United States

Boston, Massachusetts, United States

Charlotte, North Carolina, United States

Farmington, Connecticut, United States

New Orleans, Louisiana, United States

Philadelphia, Pennsylvania, United States

Newark, New Jersey, United States

Houston, Texas, 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
0
1 stars
0
Leslie Alexander
20 September 2023

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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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