Ignite Creation Date:
2024-05-06 @ 7:06 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05890963
Status:
RECRUITING
Last Update Posted:
2023-12-18
First Post:
2023-05-26
Brief Title:
10E84iMab Bispecific Antibody and VRC07-523LS Monoclonal Antibody in HIV-infected Adults
Sponsor:
David Ho
Organization:
Columbia University
Study Overview
Official Title:
Phase 1b Single Dose Clinical Trial of a Novel Long-Acting Bispecific Antibody in People With HIV to Inform Development for HIV Pre- and Post-Exposure Prophylaxis
Status:
RECRUITING
Status Verified Date:
2023-11
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:
This is an open-label phase 1b clinical trial enrolling people living with HIV PLWH who are antiretroviral therapy ART-naïve or have not been on ART for 24 weeks This study will enroll PLWH to assess the safety tolerability and antiviral effect of bispecific and long-acting bNAbs alone and in combination The study will be conducted as a single center study at National Institute for Medical Research-Mbeya Medical Research Center NIMR-MMRC in Mbeya Tanzania
20 PLWH will be sequentially enrolled into one of 5 arms each arm comprised of 4 participants Sequential enrollment will occur in the following order
Arm 1 will receive standard daily oral ART
Arm 2 will receive a single dose of 10E84iMab 600mg intravenous injection IV
Arm 3 will receive a single dose of 10E84iMab 600mg intramuscular injection IM
Arm 4 will receive a single dose of 10E84iMab 1800mg IV
Arm 5 will receive a single dose of combination therapy with both 10E84iMab 1800mg IV and VRC07-523LS 1200mg IV
20 PLWH will be sequentially enrolled into one of 5 arms each arm comprised of 4 participants Sequential enrollment will occur in the following order
Arm 1 will receive standard daily oral ART
Arm 2 will receive a single dose of 10E84iMab 600mg intravenous injection IV
Arm 3 will receive a single dose of 10E84iMab 600mg intramuscular injection IM
Arm 4 will receive a single dose of 10E84iMab 1800mg IV
Arm 5 will receive a single dose of combination therapy with both 10E84iMab 1800mg IV and VRC07-523LS 1200mg IV
Detailed Description:
Although global initiatives have made great strides in controlling the human immunodeficiency virus HIV pandemic HIV and acquired immune deficiency syndrome AIDS continue to impact the lives and livelihoods of a significant portion of the population In 2019 38 million individuals were living with HIV and 690000 died of AIDS-related causes Despite extensive global efforts for disease control over the last 20 years 17 million individuals contract HIV annually Antiretroviral therapy ART reduces morbidity and mortality associated with HIV by suppressing viral replication but does not eradicate infection There are barriers to universal ART use that include toxicities costs drug resistance and the need for lifelong adherence To overcome these barriers HIV broadly neutralizing antibodies bNAbs represent a novel approach to HIV prevention and treatment
The primary endpoint of change in viral load will be assessed at day 14 Participants will then transition to Step 2 during which all participants will take standard daily oral ART and have viral load monitored through Step 2 week 48
The primary endpoint of change in viral load will be assessed at day 14 Participants will then transition to Step 2 during which all participants will take standard daily oral ART and have viral load monitored through Step 2 week 48
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RV584 | OTHER | WRAIR IRB | None |
| W81XWH-18-2-0040 | OTHER_GRANT | None | None |