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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
HIV-1 C4-V3 Polyvalent Peptide Vaccine
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring Vaccines, Synthetic, HIV-1, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, AIDS Vaccines, HIV Therapeutic Vaccine

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Duke Univ Med Ctr

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
May 3, 2013
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Lederle-Praxis Biologicals
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1. Study Identification

Unique Protocol Identification Number
NCT00001060
Brief Title
A Phase I Trial of HIV-1 C4-V3 Polyvalent Peptide Vaccine in HIV-1 Infected Persons
Official Title
A Phase I Trial of HIV-1 C4-V3 Polyvalent Peptide Vaccine in HIV-1 Infected Persons
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2002 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Lederle-Praxis Biologicals

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Vaccines, Synthetic, HIV-1, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, AIDS Vaccines, HIV Therapeutic Vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Masking
Double
Enrollment
30 (false)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
HIV-1 C4-V3 Polyvalent Peptide Vaccine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bartlett JA
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Tacket CO
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Virani-Ketter N
Official's Role
Study Chair
Facility Information:
Facility Name
Duke Univ Med Ctr
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
9708408
Citation
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.
Results Reference
result

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

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