Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00125099
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2005-07-27
Brief Title:
Safety of and Immune Response to a DNA HIV Vaccine VRC-HIVDNA009-00-VP in HIV Infected Individuals With Acute HIV Infection
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Safety and Immunogenicity of the HIV-1 DNA Vaccine VRC-HIVDNA009-00-VP GAG-POL-NEF-MULTICLADE ENV in HIV-1 Infected Subjects Treated During Acute HIV Infection
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 evaluate whether the HIV vaccine VRC-HIVDNA009-00-VP will be safe in individuals who started antiretroviral therapy during acute HIV-1 infection The study will also test whether the vaccine can increase the immune system function in these participants
Detailed Description:
Highly active antiretroviral therapy HAART has greatly improved mortality and morbidity rates associated with HIV and AIDS However many HIV-1 infected individuals are unable to access HAART It is therefore important to develop a safe and effective therapeutic vaccine to improve immune control of viral replication and reduce the need for antiretroviral medication This study will evaluate the safety and immunogenicity of the HIV-1 DNA vaccine VRC-HIVDNA009-00-VP in treating HIV-1 infected individuals who initiated antiretroviral therapy during acute infection This study will involve a supervised treatment interruption STI in order to determine whether therapeutic vaccination results in improved immune control of viral replication
Participants in this study will be randomly assigned to receive either the therapeutic vaccine or placebo in addition to their regular HAART regimens During the first part of the study participants will receive 4 vaccinations at Weeks 0 4 8 and 24 All individuals completing the therapeutic vaccination phase defined as completing at least 3 immunizations including the Week 24 immunization will be given the opportunity to participate in the second part of the study and undergo a supervised discontinuation of HAART At Week 30 these participants will discontinue all antiretroviral treatment and will be closely monitored Participants will restart HAART if they experience a significant decline in their CD4 count an increase in their viral loads or if their physicians recommend they resume HAART At Week 52 all other participants can restart HAART at the discretion of their primary physician
21 study visits will occur over a period of 52 weeks After Week 52 monthly study visits will occur through Week 72 Study visits will last approximately two hours and will include physical exams and blood and urine collection
Participants in this study will be randomly assigned to receive either the therapeutic vaccine or placebo in addition to their regular HAART regimens During the first part of the study participants will receive 4 vaccinations at Weeks 0 4 8 and 24 All individuals completing the therapeutic vaccination phase defined as completing at least 3 immunizations including the Week 24 immunization will be given the opportunity to participate in the second part of the study and undergo a supervised discontinuation of HAART At Week 30 these participants will discontinue all antiretroviral treatment and will be closely monitored Participants will restart HAART if they experience a significant decline in their CD4 count an increase in their viral loads or if their physicians recommend they resume HAART At Week 52 all other participants can restart HAART at the discretion of their primary physician
21 study visits will occur over a period of 52 weeks After Week 52 monthly study visits will occur through Week 72 Study visits will last approximately two hours and will include physical exams and blood and urine collection
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 |
|---|---|---|---|
| ACTG A5187 | Registry Identifier | DAIDS ES Registry Number | None |
| 10010 | REGISTRY | None | None |