Ignite Creation Date:
2024-05-06 @ 12:36 PM
Last Modification Date:
2024-10-26 @ 1:01 PM
Study NCT ID:
NCT03803605
Status:
COMPLETED
Last Update Posted:
2021-12-02
First Post:
2019-01-10
Brief Title:
Study to Assess Safety and Activity of Combination Therapy of VRC07-523LS and Vorinostat on HIV-infected Persons
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
IGHID 11802 - Combination Therapy With the Novel Clearance Modality VRC07-523LS and the Latency Reversal Agent Vorinostat to Reduce the Frequency of Latent Resting CD4 T Cell Infection The VOR-07 Study
Status:
COMPLETED
Status Verified Date:
2021-07
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:
Adult participants 18-64 years old with HIV-1 Infection on ART with a CD4 T cell count 350 cellsmm3 and viral suppression for 24 months will be enrolled on this study Participants will receive two series of combination therapy consisting of one 1 intravenous IV dose of VRC-HIVMAB075-00-AB VRC07-523LS followed by 10 oral PO doses of Vorinostat VOR taken every 72 hours Each series will last approximately 1 month and the two series will be separated by at least one month Combination ART is maintained throughout the study Participants will be on this study for approximately 28 weeks or about 7 months
The purpose of this study is to
Evaluate the safety of two series of a VRC07-523LS infusion followed by multiple oral doses of VOR
Determine if combining VRC07-523LS and VOR can have an impact on non-active HIV virus
The purpose of this study is to
Evaluate the safety of two series of a VRC07-523LS infusion followed by multiple oral doses of VOR
Determine if combining VRC07-523LS and VOR can have an impact on non-active HIV virus
Detailed Description:
This is a phase I single-site open-label study to evaluate the effects of VOR given in combination with VRC07-523LS on persistent HIV-1 Infection in HIV-infected individuals suppressed on ART
The investigators hypothesize that combination therapy with VRC07-523LS and VOR will be safe and well-tolerated by HIV-1-infected participants suppressed on ART
In Step 1 all participants will undergo study screening and enrollment Participants will complete a baseline Leukapheresis 1 In order to advance to Step 2 participants must be found to have a baseline measurement of the frequency of resting CD4 T cell infection 03 infectious units per million IUPM determined by Quantitative Viral Outgrowth Assay QVOA lower limit of detection is 003 IUPM as a further decrease from this low frequency of infection cannot be definitively measured given the QVOA assay threshold
These criteria assure that eligible enrolled participants will have a measurable endpoint thus decreasing risk of study participation for participants who would not have a measurable outcome
Participants progressing to Steps 2 and 3 will receive two series of a single VRC07-523LS infusion followed by multiple doses of VOR
In the first series Step 2 participants will receive one VRC07-523LS 40 mgkg infusion infusion 1 on Day 0 followed by the 1st dose of VOR 400 mg PO taken at home on Day 2 Participants will take VOR 400 mg PO every 72 hours for a total of 10 doses
In the second series Step 3 participants will receive one VRC07-523LS 40 mgkg infusion infusion 2 on Day 60 followed by the 1st of the 2nd series of VOR dose of VOR 400 mg PO on Day 62 As in the previous Step participants will take VOR 400 mg PO every 72 hours for a total of 10 doses
Step 4 consists of 2 visits The post-study treatment leukapheresis 2 will be completed 5 - 8 weeks after the 2nd VRC07-523LS infusion The End of Study Visit EOS will be scheduled to 2 - 4 weeks following the final leukapheresis 2 visit
The investigators hypothesize that combination therapy with VRC07-523LS and VOR will be safe and well-tolerated by HIV-1-infected participants suppressed on ART
In Step 1 all participants will undergo study screening and enrollment Participants will complete a baseline Leukapheresis 1 In order to advance to Step 2 participants must be found to have a baseline measurement of the frequency of resting CD4 T cell infection 03 infectious units per million IUPM determined by Quantitative Viral Outgrowth Assay QVOA lower limit of detection is 003 IUPM as a further decrease from this low frequency of infection cannot be definitively measured given the QVOA assay threshold
These criteria assure that eligible enrolled participants will have a measurable endpoint thus decreasing risk of study participation for participants who would not have a measurable outcome
Participants progressing to Steps 2 and 3 will receive two series of a single VRC07-523LS infusion followed by multiple doses of VOR
In the first series Step 2 participants will receive one VRC07-523LS 40 mgkg infusion infusion 1 on Day 0 followed by the 1st dose of VOR 400 mg PO taken at home on Day 2 Participants will take VOR 400 mg PO every 72 hours for a total of 10 doses
In the second series Step 3 participants will receive one VRC07-523LS 40 mgkg infusion infusion 2 on Day 60 followed by the 1st of the 2nd series of VOR dose of VOR 400 mg PO on Day 62 As in the previous Step participants will take VOR 400 mg PO every 72 hours for a total of 10 doses
Step 4 consists of 2 visits The post-study treatment leukapheresis 2 will be completed 5 - 8 weeks after the 2nd VRC07-523LS infusion The End of Study Visit EOS will be scheduled to 2 - 4 weeks following the final leukapheresis 2 visit
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 |
|---|---|---|---|
| U01AI117844 | NIH | None | httpsreporternihgovquickSearchU01AI117844 |