Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00021762
Status:
WITHDRAWN
Last Update Posted:
2021-11-01
First Post:
2001-08-04
Brief Title:
Effects of Immunization With HIV-1 Immunogen Plus Anti-HIV Treatment Interruption on the Levels of HIV
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Pilot Phase II Evaluation of the Effects on HIV Replication of Immunization With a gp120-Depleted Inactivated Whole Virus Vaccine Combined With Exposures to Replicating Autologous HIV by Scheduled Treatment Interruptions a Rollover Study of A5057
Status:
WITHDRAWN
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 whether or not an HIV vaccination will help the body control the amount of HIV virus in blood viral load in patients who are not taking anti-HIV medicines
Doctors are not sure why the body fails to control HIV viral load in most people infected with HIV The vaccine Remune has been shown to boost part of the bodys immune response to HIV in patients whose viral load has been lowered with anti-HIV drugs This study will test the ability of Remune to improve the bodys immune response and to lower HIV viral load in patients who stop taking anti-HIV drugs for short periods of time
Doctors are not sure why the body fails to control HIV viral load in most people infected with HIV The vaccine Remune has been shown to boost part of the bodys immune response to HIV in patients whose viral load has been lowered with anti-HIV drugs This study will test the ability of Remune to improve the bodys immune response and to lower HIV viral load in patients who stop taking anti-HIV drugs for short periods of time
Detailed Description:
Investigators of the pathogenesis of HIV infection agree that one of the most critical questions in HIV disease is why immune responses do not control HIV replication in the vast majority of infected individuals More specifically the absence of large lymphocyte proliferation response LPR to HIV antigens in these individuals and their presence in long-term nonprogressors LTNPs with a low viral load requires an investigation of whether a causal relationship exists between LPR to HIV and control of HIV replication Immunization with Remune has been shown to induce large LPR to HIV antigens when administered to patients in whom HIV replication has been suppressed with antiretroviral therapy ART A5120 will evaluate the abilities of immunization with HIV-1 Immunogen and of STIs to enhance immune responses that may control HIV replication in the absence of antiretroviral drugs
Patients remain in the treatment arm vaccine versus adjuvant placebo to which they were randomized on entry to protocol A5057 and both the participant and investigator remain blinded as to the assignment Patients may receive up to 3 injections of vaccineadjuvant control in 1 of the following 2 groups
Arm A HIV-1 immunogen at study entry and at Week 9 in Step 3 and Step 5 Arm B HIV-1 immunogen placebo at study entry and at Week 9 in Step 3 and Step 5
ART is required during Steps 1 3 5 and 8 but is not provided by this study The study is organized into the following series of steps
Step 1 ART and injection receive injection of vaccineadjuvant control Patients remain on ART for 6 to 8 weeks
Step 2 first STI all ART is stopped for up to 8 weeks with careful monitoring of viral load and CD4 T cells Patients whose viral load is controlled may remain on Step 2 for an additional 6 weeks
Step 3 resumption of ART restart ART for 14 weeks Eligible patients receive an immunization with vaccineadjuvant control at Week 9
Step 4 second STI identical to Step 2 Step 5 resumption of ART identical to Step 3 Step 6 analytical treatment interruption ATI analytical read-out discontinuation of ART for up to 14 weeks
Step 7 long-term follow-up without ART open only to patients with control of viral load who agree to participate in continued treatment withdrawal
Step 8 final resumption of ART patients are followed for 8 weeks on ART to document the effect of restarting ART on suppression of viral load Patients advance through steps as criteria for HIV RNA level CD4 count and treatment are met
Patients have regular clinic visits for medicalmedication histories physical examinations and laboratory tests for viral load and immunological parameters
Patients remain in the treatment arm vaccine versus adjuvant placebo to which they were randomized on entry to protocol A5057 and both the participant and investigator remain blinded as to the assignment Patients may receive up to 3 injections of vaccineadjuvant control in 1 of the following 2 groups
Arm A HIV-1 immunogen at study entry and at Week 9 in Step 3 and Step 5 Arm B HIV-1 immunogen placebo at study entry and at Week 9 in Step 3 and Step 5
ART is required during Steps 1 3 5 and 8 but is not provided by this study The study is organized into the following series of steps
Step 1 ART and injection receive injection of vaccineadjuvant control Patients remain on ART for 6 to 8 weeks
Step 2 first STI all ART is stopped for up to 8 weeks with careful monitoring of viral load and CD4 T cells Patients whose viral load is controlled may remain on Step 2 for an additional 6 weeks
Step 3 resumption of ART restart ART for 14 weeks Eligible patients receive an immunization with vaccineadjuvant control at Week 9
Step 4 second STI identical to Step 2 Step 5 resumption of ART identical to Step 3 Step 6 analytical treatment interruption ATI analytical read-out discontinuation of ART for up to 14 weeks
Step 7 long-term follow-up without ART open only to patients with control of viral load who agree to participate in continued treatment withdrawal
Step 8 final resumption of ART patients are followed for 8 weeks on ART to document the effect of restarting ART on suppression of viral load Patients advance through steps as criteria for HIV RNA level CD4 count and treatment are met
Patients have regular clinic visits for medicalmedication histories physical examinations and laboratory tests for viral load and immunological parameters
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| AACTG A5120 | Registry Identifier | DAIDS ES Registry Number | None |
| 10938 | REGISTRY | None | None |
| ACTG A5120 | None | None | None |