A Phase I Trial of HIV-1 C4-V3 Polyvalent Peptide Vaccine in HIV-1 Infected Persons

Inclusion Criteria Concurrent Medication: Allowed: Other medically indicated vaccinations, provided they are administered at least 2 weeks before or after any study injection. Alcohol use limited to 1 oz per day of 100 proof. Patients must have: HIV infection without evidence of AIDS. CD4 count > 500 cells/mm3. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Current evidence of underlying lung or liver disease. Suspected or diagnosed allergy to any vaccine component. Medical contraindication to protocol participation. Undergoing allergy skin testing or desensitization. Concurrent Medication: Excluded: Antiretroviral therapy (unless clinically indicated and with approval of investigator). Immunosuppressive or immunomodulatory therapy. Nonsteroidal anti-inflammatory agents (except short-term therapy for acute conditions). Drugs with known hepatotoxicity. Alcohol intake > 1 oz per day of 100 proof. Patients with the following prior conditions are excluded: History of underlying lung disease. Abnormal chest radiograph within 2 weeks prior to first vaccine injection. History of underlying liver disease. Abnormal hepatitis B surface antigen or hepatitis C antibody test within 2 weeks prior to first vaccine injection. Abnormal liver function tests within 30 days prior to study entry. Evidence of uveitis by slit lamp exam within 2 weeks prior to study entry. Anergic as evidenced by negative skin test responses to all three antigens in a panel consisting of tetanus toxoid, mumps, and Candida albicans, within 6 weeks prior to first vaccine injection. Prior participation on an HIV vaccine trial. Prior Medication: Excluded within the past 3 months: Antiretroviral therapy. Immunosuppressive drugs. Alpha interferon or any immunomodulatory drugs. Any investigational HIV drugs or therapies. Current alcohol abuse.