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.

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