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)

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.

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