Ignite Creation Date:
2024-07-17 @ 11:16 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06484335
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-05-31
Brief Title:
Safety and Efficacy of Broadly Neutralizing Antibodies Combined With Therapeutic Vaccination for the Induction of HIV Remission
Sponsor:
Henry M Jackson Foundation for the Advancement of Military Medicine
Organization:
Henry M Jackson Foundation for the Advancement of Military Medicine
Study Overview
Official Title:
Approach to Control HIV With Immune Enhancement and Vaccination ACHIEV Safety and Efficacy of Broadly Neutralizing Antibodies Combined With Therapeutic Vaccination for the Induction of HIV Remission
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
ACHIEV
Brief Summary:
This is a phase I randomized double-blind placebo-controlled clinical trial to investigate the safety of VRC07-523LS and PGDM1400LS in combination with ChAdOx1tHIVconsv1 ChAdOx1HIVconsv62 prime MVAtHIVconsv4 and A244d11gp120ALFQ vaccination and the impact on viral load setpoint during analytic treatment interruption ATI in people living with human immunodeficiency virus-1 HIV-1 PLWH who have initiated or will initiate antiretroviral therapy ART during acute HIV-1 infection AHI
Detailed Description:
The overall goal of this phase I randomized double-blinded placebo-controlled clinical trial to investigate the safety of VRC07-523LS and PGDM1400LS in combination with ChAdOx1tHIVconsv1 ChAdOx1tHIVconsv62 MVAtHIVconsv4 and A244d11 gp120ALFQ vaccination and the impact on viral load setpoint during ATI in PLWH who initiated ART during AHI This study is exploratory in nature and the anticipated outcome of this trial includes the following
1 To evaluate the safety of VRC07-523LS and PGDM1400LS in combination with ChAdOx1tHIVconsv1 ChAdOx1HIVconsv62 prime MVAtHIVconsv4 and A244d11 gp120ALFQ vaccination in PLWH who initiated ART during AHI
2 2 To evaluate the impact of VRC07-523LS and PGDM1400LS in combination with ChAdOx1tHIVconsv1 ChAdOx1HIVconsv62 prime MVAtHIVconsv4 and A244d11 gp120ALFQ vaccination on viral load setpoint after viral rebound during ATI
1 To evaluate the safety of VRC07-523LS and PGDM1400LS in combination with ChAdOx1tHIVconsv1 ChAdOx1HIVconsv62 prime MVAtHIVconsv4 and A244d11 gp120ALFQ vaccination in PLWH who initiated ART during AHI
2 2 To evaluate the impact of VRC07-523LS and PGDM1400LS in combination with ChAdOx1tHIVconsv1 ChAdOx1HIVconsv62 prime MVAtHIVconsv4 and A244d11 gp120ALFQ vaccination on viral load setpoint after viral rebound during ATI
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None