Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001060
Status:
COMPLETED
Last Update Posted:
2013-05-06
First Post:
1999-11-02
Brief Title:
A Phase I Trial of HIV-1 C4-V3 Polyvalent Peptide Vaccine in HIV-1 Infected Persons
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase I Trial of HIV-1 C4-V3 Polyvalent Peptide Vaccine in HIV-1 Infected Persons
Status:
COMPLETED
Status Verified Date:
2013-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Freunds 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
Patients are randomized to receive low-dose or high-dose HIV-1 C4-V3 polyvalent peptide vaccine in incomplete Freunds 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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DATRI 0101 | Registry Identifier | DAIDS ES Registry Number | None |
| 11741 | REGISTRY | None | None |