A Phase I Trial of HIV-1 C4-V3 Polyvalent Peptide Vaccine in HIV-1 Infected Persons
Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001
Trial Information
Current as of May 11, 2025
Completed
Keywords
ClinConnect Summary
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.
Patients are randomized to receive low-dose or high-dose HIV-1 C4-V3 polyvalent peptide vaccine in incomplete Freund's adjuvant (IFA), or IFA alone as control. Inject...
Gender
ALL
Eligibility criteria
- • 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.
About National Institute Of Allergy And Infectious Diseases (Niaid)
The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Durham, North Carolina, United States
Patients applied
Trial Officials
Bartlett JA
Study Chair
Tacket CO
Study Chair
Virani-Ketter N
Study Chair
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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