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)

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.