A Phase I Trial of HIV-1 C4-V3 Polyvalent Peptide Vaccine in HIV-1 Infected Persons
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ClinicalTrials.gov Identifier: NCT00001060 |
Recruitment Status
:
Completed
First Posted
: August 31, 2001
Last Update Posted
: May 6, 2013
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Tracking Information | ||||||||||
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First Submitted Date ICMJE | November 2, 1999 | |||||||||
First Posted Date ICMJE | August 31, 2001 | |||||||||
Last Update Posted Date | May 6, 2013 | |||||||||
Study Start Date ICMJE | Not Provided | |||||||||
Primary Completion Date | Not Provided | |||||||||
Current Primary Outcome Measures ICMJE | Not Provided | |||||||||
Original Primary Outcome Measures ICMJE | Not Provided | |||||||||
Change History | Complete list of historical versions of study NCT00001060 on ClinicalTrials.gov Archive Site | |||||||||
Current Secondary Outcome Measures ICMJE | Not Provided | |||||||||
Original Secondary Outcome Measures ICMJE | Not Provided | |||||||||
Current Other Outcome Measures ICMJE | Not Provided | |||||||||
Original Other Outcome Measures ICMJE | Not Provided | |||||||||
Descriptive Information | ||||||||||
Brief Title ICMJE | A Phase I Trial of HIV-1 C4-V3 Polyvalent Peptide Vaccine in HIV-1 Infected Persons | |||||||||
Official Title ICMJE | A Phase I Trial of HIV-1 C4-V3 Polyvalent Peptide Vaccine in HIV-1 Infected Persons | |||||||||
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. |
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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. |
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Study Type ICMJE | Interventional | |||||||||
Study Phase | Phase 1 | |||||||||
Study Design ICMJE | Masking: Double Primary Purpose: Prevention |
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Condition ICMJE | HIV Infections | |||||||||
Intervention ICMJE | Biological: HIV-1 C4-V3 Polyvalent Peptide Vaccine | |||||||||
Study Arms | Not Provided | |||||||||
Publications * | 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. | |||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||||||||
Recruitment Status ICMJE | Completed | |||||||||
Enrollment ICMJE |
30 | |||||||||
Original Enrollment ICMJE | Same as current | |||||||||
Actual Study Completion Date | June 2002 | |||||||||
Primary Completion Date | Not Provided | |||||||||
Eligibility Criteria ICMJE | Inclusion Criteria Concurrent Medication: Allowed:
Patients must have:
Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded:
Concurrent Medication: Excluded:
Patients with the following prior conditions are excluded:
Prior Medication: Excluded within the past 3 months:
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Sex/Gender |
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Ages | 18 Years to 50 Years (Adult) | |||||||||
Accepts Healthy Volunteers | No | |||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
Listed Location Countries ICMJE | United States | |||||||||
Removed Location Countries | ||||||||||
Administrative Information | ||||||||||
NCT Number ICMJE | NCT00001060 | |||||||||
Other Study ID Numbers ICMJE | DATRI 101 11741 ( Registry Identifier: DAIDS ES Registry Number ) DATRI 0101 |
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Has Data Monitoring Committee | Not Provided | |||||||||
U.S. FDA-regulated Product | Not Provided | |||||||||
IPD Sharing Statement | Not Provided | |||||||||
Responsible Party | National Institute of Allergy and Infectious Diseases (NIAID) | |||||||||
Study Sponsor ICMJE | National Institute of Allergy and Infectious Diseases (NIAID) | |||||||||
Collaborators ICMJE | Lederle-Praxis Biologicals | |||||||||
Investigators ICMJE |
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PRS Account | National Institute of Allergy and Infectious Diseases (NIAID) | |||||||||
Verification Date | May 2013 | |||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |