A Phase I Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of Immuno-AG Recombinant HIV gp160 in Asymptomatic HIV Seropositive Individuals

Inclusion Criteria

Concurrent Medication: Recommended:

• Prophylaxis with isoniazid in patients not previously treated.

Patients must have:

• HIV seropositivity by Western blot.
• Normal history and physical exam (generalized lymphadenopathy is acceptable).
• Mean CD4 cell count = or > 600 cells/mm3 for all visits (minimum 2 counts) within 60 days prior to study entry, with no single count < 450 cells/mm3.
• Negative PPD test or normal chest x-ray with positive PPD (induration = or > 5 mm).

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Hepatitis B surface antigen positive.
• Evidence of an AIDS- or ARC-defining opportunistic infection.
• Evidence of disseminated tuberculosis, severe or persistent candidiasis, oral hairy leukoplakia, prolonged or very severe diarrhea, herpes zoster, or herpes simplex persisting more than one month.
• Active syphilis.

Patients with the following prior conditions are excluded:

• Evidence of psychiatric disorder within the past year that would impair adherence to the protocol.
• History of an AIDS- or ARC-defining opportunistic infection.
• History of disseminated tuberculosis, severe or persistent candidiasis, oral hairy leukoplakia, prolonged or very severe diarrhea, herpes zoster, or herpes simplex persisting more than one month.

Prior Medication:

Excluded:

• Immunomodulating agents (e.g., isoprinosine, imuthiol, lithium) within 90 days of screening.
• Immunosuppressive medications within the previous 3 months.
• Zidovudine (AZT) or any antiviral agent (including interferon) within the previous 6 months.
• Vaccination against other pathogens within 4 weeks of initial screening laboratory work.

Use of illicit drugs or significant amounts of alcohol that could significantly interfere with study compliance.