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

NCT00001060 | Completed Phase 1

• 3 other identifiers: DATRI 10111741DATRI 0101
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV Infections

Keywords

Vaccines, Synthetic; HIV-1; Acquired Immunodeficiency Syndrome; AIDS-Related Complex; AIDS Vaccines; HIV Therapeutic Vaccine

Interventions

HIV-1 C4-V3 Polyvalent Peptide Vaccine BIOLOGICAL

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Lederle-Praxis Biologicals: collaborator

Study Sites (1)

Duke Univ Med Ctr

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

• Bartlett JA, Wasserman SS, Hicks CB, Dodge RT, Weinhold KJ, Tacket CO, Ketter N, Wittek AE, Palker TJ, Haynes BF. Safety and immunogenicity of an HLA-based HIV envelope polyvalent synthetic peptide immunogen. DATRI 010 Study Group. Division of AIDS Treatment Research Initiative. AIDS. 1998 Jul 30;12(11):1291-300. doi: 10.1097/00002030-199811000-00010.

  PMID: 9708408 RESULT

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome; AIDS-Related Complex

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Study Officials

• Bartlett JA

  STUDY CHAIR

• Tacket CO

  STUDY CHAIR

• Virani-Ketter N

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: DOUBLE
• Purpose: PREVENTION
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: June 1, 2002
• Last Updated: May 6, 2013

Record last verified: 2013-05

Locations

US (1)