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

Completed · Phase 1

Conditions studied: HIV Infections

In brief

To determine the safety of immunization with HIV-1 C4-V3 polyvalent peptide vaccine in HIV-infected persons. To determine the proportion of study participants immunized who develop new specificities or increased levels of neutralizing and other antibody responses, T-cell proliferative responses, and Class I restricted cytotoxic T-lymphocyte ( CTL ) responses. HIV-1 C4-V3 polyvalent peptide vaccine contains amino acid sequences for selected epitopes from four of the most common HIV isolates in the United States and Europe, predicted to represent about 50-90 percent of the HIV isolates in the United States. It includes epitopes that generate potentially salutary immune responses and deletes epitopes that generate immune responses which might contribute to further immunopathogenesis.

Key facts

Study ID

NCT00001060

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

30

Expected to finish

2002-06-01

Last updated by the study team

2013-05-06

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Duke Univ Med Ctr — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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