We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00001060
First Posted: August 31, 2001
Last Update Posted: May 6, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Lederle-Praxis Biologicals
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
  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: Masking: Double
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001060


Locations
United States, North Carolina
Duke Univ Med Ctr
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
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 ( Registry Identifier: DAIDS ES Registry Number )
DATRI 0101
First Submitted: November 2, 1999
First Posted: August 31, 2001
Last Update Posted: May 6, 2013
Last Verified: May 2013

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
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs