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.