Status:
COMPLETED
Active Immunization of HIV-1 Infected, Pregnant Women With CD4 Lymphocyte Counts >= 400/mm3: A Phase I Study of Safety and Immunogenicity of VaxSyn Recombinant gp160 (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
To evaluate the safety of gp160 vaccine (VaxSyn) in HIV-1 infected pregnant women with CD4 counts \>= 400 cells/mm3. To evaluate the immunogenicity of this vaccine in pregnant women and the passive ac...
Detailed 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 ...
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
July 1 1998
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00000777
End Date
July 1 1998
Last Update
October 28 2021
Active Locations (2)
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1
Yale Univ Med School
New Haven, Connecticut, United States, 06504
2
Vanderbilt Univ Hosp
Nashville, Tennessee, United States, 37232