Search / Trial NCT00001041

Active Immunization of HIV-1 Infected, Pregnant Women With CD4 Lymphocyte Counts >= 400/mm3: A Phase I Study of Safety and Immunogenicity of MN rgp120/HIV-1 Vaccine (NOTE: Some Patients Receive Placebo)

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

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Trial Information

Current as of December 10, 2023

Completed

Keywords

Vaccines, Synthetic Pregnancy Pregnancy Complications, Infectious Hiv Envelope Protein Gp120 Aids Vaccines Hiv Therapeutic Vaccine

Description

Evidence suggests that an advanced stage of disease with high plasma viremia is associated with increased transmission of HIV-1 to the fetus. Slowing the progression of disease, reducing the titer of virus in plasma, and increasing the titer of epitope-specific antibody are potentially attainable goals through active immunization of the mother during pregnancy. Pregnant women are randomized to receive an initial injection of MN rgp120 vaccine or alum placebo between week 16 and week 24 of gestation, followed by monthly booster injections concluding at the end of pregnancy, for a total of f...

Gender

Female

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • AZT.
  • Acyclovir.
  • Patients must have:
  • HIV-1 infection.
  • CD4 count >= 400 cells/mm3.
  • No AIDS-defining illness or other systemic manifestations related to HIV (other than generalized lymphadenopathy).
  • HIV p24 < 30 pg/ml.
  • Proven pregnancy in the 16th to 24th week of gestation at study entry, with no special obstetrical risks.
  • Concurrent AZT therapy is permitted.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following symptoms and conditions are excluded:
  • Known hypersensitivity to a component of the vaccine.
  • Evidence of fetal abnormality on ultrasound.
  • Evidence of maternal risk factors including insulin-dependent diabetes, moderate to severe hypertension, repeated fetal wastage (> 3), Rh-sensitization or other blood group alloimmunization, severe renal disease, previous infants with malformations or other factors that obstetrically are judged to constitute a special risk of spontaneous abortion or premature birth.
  • Active syphilis.
  • Hepatitis B surface antigen positive.
  • Concurrent Medication:
  • Excluded:
  • Antiretroviral or immunomodulating agent other than AZT during the pregnancy.
  • Prior Medication:
  • Excluded:
  • Antiretroviral or immunomodulating agent other than AZT within 90 days prior to study entry.
  • Current use of illicit drugs or known chronic alcohol use.

Attachments

readout_NCT00001041_2023-12-10.pdf

4.5 MB

NCT00001041_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

Saint Louis, Missouri, United States

Saint Louis, Missouri, United States

Rochester, New York, United States

San Francisco, California, United States

Baltimore, Maryland, United States

San Francisco, 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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