Status:

WITHDRAWN

Active Immunization of HIV-Infected Pregnant Women: A Phase I Study of Safety and Immunogenicity of a rgp120/HIV-1 Vaccine (NOTE: Some Patients Receive Placebo)

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Conditions:

HIV Infections

Pregnancy

Eligibility:

FEMALE

16-40 years

Phase:

PHASE1

Brief Summary

PRIMARY: To evaluate the short-term safety of rgp120/HIV-1SF2 vaccine versus MF59 placebo administered to HIV-infected pregnant women. SECONDARY: To evaluate the immunogenicity and long-term safety o...

Detailed Description

Active immunization of HIV-infected women during pregnancy may slow the progression of maternal disease, reduce the titer of virus in maternal plasma, and increase the titer of epitope-specific antibo...

Eligibility Criteria

Inclusion Criteria

Concurrent Medication:

Allowed during pregnancy:

  • AZT.
  • Methadone maintenance.

NOTE:

  • Patients may not initiate antiretroviral therapy for disease progression.

NOTE:

  • Patients may change from AZT to another antiretroviral agent or may begin antiretroviral therapy following delivery, if clinically indicated.

Patients must have:

  • Documented HIV infection.
  • CD4 count >= 400 cells/mm3 (average of two determinations obtained 1 week apart).
  • No clinical criteria for a diagnosis of AIDS.
  • HIV p24 antigen <= 30 pg/ml.
  • Estimated gestational age between 16 and 24 weeks, confirmed by baseline sonogram that does not demonstrate any congenital abnormalities considered to be incompatible with life.
  • Intention to carry pregnancy to term.
  • Willingness to be followed by an ACTU for the duration of the study.

NOTE:

  • Father of the fetus (if available after a reasonable attempt to contact him) must provide informed consent.

Prior Medication:

Allowed:

  • AZT.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Known hypersensitivity to a component of the vaccine.
  • Hepatitis B antigen positive at study entry.
  • Evidence of life-threatening or other serious pre-existing fetal abnormalities (e.g., anencephaly, renal agenesis, Potter's syndrome).
  • Evidence of syphilis that requires therapy during this pregnancy.
  • Intention to breast-feed.

Presence of obstetrical high-risk factors such as:

  • insulin-dependent diabetes
  • hypertension requiring the use of anti-hypertensive therapy
  • repeated intrauterine fetal demise
  • Rh-sensitization or other blood group alloimmunization
  • diseases requiring use of immunosuppressive therapy (e.g., asthma, lupus).

Concurrent Medication:

Excluded during pregnancy:

  • Antiretrovirals other than AZT.
  • Immunomodulating agents (e.g., HIVIG, IVIG).
  • Other investigational drugs or immunosuppressive agents.

NOTE:

  • Patients may change from AZT to another antiretroviral agent or may begin antiretroviral therapy following delivery, if clinically indicated.

Prior Medication:

Excluded within 90 days prior to study entry:

  • Antiretrovirals other than AZT.
  • Immunomodulating agents (e.g., HIVIG, IVIG).

Current use of illicit drugs or chronic alcohol use by patient history.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT00001046

Last Update

November 1 2021

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Active Immunization of HIV-Infected Pregnant Women: A Phase I Study of Safety and Immunogenicity of a rgp120/HIV-1 Vaccine (NOTE: Some Patients Receive Placebo) | DecenTrialz