A Placebo-Controlled, Phase I, Pilot Clinical Trial to Evaluate the Safety and Immunogenicity of ENV 2-3, a Yeast-Derived Recombinant Envelope Protein of Human Immunodeficiency Virus-1, in Combination With MTP-PE/MF59 in Individuals With HIV Infection (Placebo Patients Receive MF59 Emulsion Only)

Inclusion Criteria

Patients must be:

• Healthy HIV-seropositive adults (generalized lymphadenopathy, seborrheic dermatitis acceptable).
• Negative for HIV plasma culture.
• Available for 6 months follow-up (patients in Pilot study) or 10 months follow-up (patients in Parts A and B).

Prior Medication: Required:

• Part B: Zidovudine (AZT), tolerating a dose of 500 - 600 mg/day for at least 4 months prior to entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

• Evidence of psychological disorder during the past year that would impair adherence to the protocol.
• Evidence of an AIDS defining opportunistic infection.

Prior Medication:

Excluded:

• Any potential immunomodulating agents (e.g., isoprinosine, imuthiol, lithium) within 90 days of screening.
• Immunosuppressive medications during the past 3 months.
• Part A: Use of zidovudine (AZT) for more than 30 days in the preceding 6 months, or any AZT within the last 30 days.
• Parts A and B: Any non-AZT antiretroviral drug.
• Any other investigational agent within the past 30 days.
• Immunoglobulins within the past 60 days.

Patients may not have the following prior conditions:

• Evidence of psychological disorder during the past year that would impair adherence to the protocol.
• History of an AIDS-defining opportunistic infection.

Use of illicit drugs or significant amounts of alcohol that, in the opinion of the principal investigator, would interfere with compliance with the study.