Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005779
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2000-06-03
Brief Title:
Safety of the Candidate Vaccine C4-V3 Alone or With Interleukin-12 IL-12 in HIV-Infected Patients Receiving Effective Anti-HIV Drug Therapy
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 Limited-Center Sequential Cohort Trial of HIV Vaccine Polyvalent Peptide Vaccine C4-V3 in Conjunction With Interleukin-12 in Subjects With Maximal Suppression of HIV Replication and CD4 Count 400 Cellsmm3
Status:
COMPLETED
Status Verified Date:
2021-10
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:
The purpose of this study is to see if it is safe to give C4-V3 a possible HIV vaccine alone or in conjunction with 4 different doses of interleukin-12 IL-12 to HIV-infected patients who are taking anti-HIV drugs that have lowered the amount of HIV in patients blood This study has been changed so that vaccine is administered alone or with 4 different doses of IL-12 Immune cells known as cytotoxic T lymphocytes CTLs help destroy HIV-infected cells However in most patients CTLs decrease over time This allows HIV levels to rise and AIDS symptoms to develop The C4-V3 vaccine contains small pieces of HIV protein that can boost CTL levels allowing the bodys immune system to fight HIV Giving IL-12 a normal part of the immune system with C4-V3 may make the vaccine more effective
Detailed Description:
Cytotoxic T lymphocyte CTL responses are important to the initial decrease in HIV viral load seen in the first several months after acute infection These beneficial CTL responses diminish with disease progression and cannot be recovered with antiretroviral therapy alone Recent studies suggest a vaccine may help restore CTL responses This study tests the effectiveness of the C4-V3 vaccine a synthetic peptide vaccine representing 4 epitopes from HIV gp120 including an HLA B7-restricted CTL epitope Administering IL-12 an immunostimulatory cytokine in conjunction with C4-V3 may enhance HIV-1 specific immune responses and global immune function
All patients continue their antiretroviral regimen during the study Twelve patients are assigned equally to 1 of 3 cohorts all patients receive 4 doses of C4-V3 Cohort 1 receives C4-V3 alone once all 4 patients have received 2 doses and completed 8 weeks of treatment toxicity data are reviewed Barring serious adverse events 4 patients are enrolled in Cohort 2 to receive C4-V3 plus a low dose of IL-12 near the vaccine injection sites Once all 4 patients have received 2 doses of C4-V3IL-12 and completed 8 weeks of treatment toxicity data are reviewed Barring serious adverse events 4 patients are enrolled in Cohort 3 to receive C4-V3 plus a higher dose of IL-12 administered as above AS PER AMENDMENT 8100 Twenty patients are assigned equally to 1 of 5 cohorts all patients receive 4 doses of C4-V3 Cohort 1 receives C4-V3 alone once all 4 patients have received 2 doses and completed 6 weeks of treatment toxicity data are reviewed Barring serious adverse events 4 additional patients are enrolled in Cohort 2 to receive C4-V3 plus a low dose dose level 1 of IL-12 Barring serious adverse events 4 additional patients are enrolled in Cohort 3 to receive C4-V3 plus a higher dose dose level 2 of IL-12 Barring serious adverse events 4 additional patients are enrolled in Cohort 4 to receive C4-V3 plus a higher dose dose level 3 of IL-12 Barring serious adverse events 4 patients are enrolled in Cohort 5 to receive C4-V3 plus a higher dose dose level 4 of IL-12 Patients are followed for safety evaluations and changes in viral load through Week 48 If toxicity related to C4-V3 or IL-12 persists through Week 48 the affected patients are followed until resolution of the toxicity
All patients continue their antiretroviral regimen during the study Twelve patients are assigned equally to 1 of 3 cohorts all patients receive 4 doses of C4-V3 Cohort 1 receives C4-V3 alone once all 4 patients have received 2 doses and completed 8 weeks of treatment toxicity data are reviewed Barring serious adverse events 4 patients are enrolled in Cohort 2 to receive C4-V3 plus a low dose of IL-12 near the vaccine injection sites Once all 4 patients have received 2 doses of C4-V3IL-12 and completed 8 weeks of treatment toxicity data are reviewed Barring serious adverse events 4 patients are enrolled in Cohort 3 to receive C4-V3 plus a higher dose of IL-12 administered as above AS PER AMENDMENT 8100 Twenty patients are assigned equally to 1 of 5 cohorts all patients receive 4 doses of C4-V3 Cohort 1 receives C4-V3 alone once all 4 patients have received 2 doses and completed 6 weeks of treatment toxicity data are reviewed Barring serious adverse events 4 additional patients are enrolled in Cohort 2 to receive C4-V3 plus a low dose dose level 1 of IL-12 Barring serious adverse events 4 additional patients are enrolled in Cohort 3 to receive C4-V3 plus a higher dose dose level 2 of IL-12 Barring serious adverse events 4 additional patients are enrolled in Cohort 4 to receive C4-V3 plus a higher dose dose level 3 of IL-12 Barring serious adverse events 4 patients are enrolled in Cohort 5 to receive C4-V3 plus a higher dose dose level 4 of IL-12 Patients are followed for safety evaluations and changes in viral load through Week 48 If toxicity related to C4-V3 or IL-12 persists through Week 48 the affected patients are followed until resolution of the toxicity
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 |
|---|---|---|---|
| ACTG A5049 | Registry Identifier | DAIDS ES Registry Number | None |
| AACTG A5049 | None | None | None |
| 10893 | REGISTRY | None | None |