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

This study has been completed.
Sponsor:
Collaborator:
Lederle-Praxis Biologicals
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00001060
First received: November 2, 1999
Last updated: May 3, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
HIV Infections
Biological: HIV-1 C4-V3 Polyvalent Peptide Vaccine
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: A Phase I Trial of HIV-1 C4-V3 Polyvalent Peptide Vaccine in HIV-1 Infected Persons

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 30
Study Completion Date: June 2002
Detailed Description:

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. Injections are administered on day 0 and at weeks 4, 8, 12, and 24. When patients entered at the lower vaccine dose (Cohort A) reach week 6, the data is reviewed and the higher dose cohort (Cohort B) will begin. When both cohorts reach week 14, data is evaluated and Cohort C begins vaccine administrations at a chosen vaccine dose. Within each cohort, eight patients receive vaccine plus IFA and two patients receive IFA alone. Patients are followed to week 52; 18 clinic visits and four telephone calls are required.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001060

Locations
United States, North Carolina
Duke Univ Med Ctr
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Lederle-Praxis Biologicals
Investigators
Study Chair: Bartlett JA
Study Chair: Tacket CO
Study Chair: Virani-Ketter N
  More Information

Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00001060     History of Changes
Other Study ID Numbers: DATRI 101, 11741, DATRI 0101
Study First Received: November 2, 1999
Last Updated: May 3, 2013
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Vaccines, Synthetic
HIV-1
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
AIDS Vaccines
HIV Therapeutic Vaccine

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on September 30, 2014