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)

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.

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety