Ignite Creation Date:
2024-05-06 @ 1:38 AM
Last Modification Date:
2024-10-26 @ 11:06 AM
Study NCT ID:
NCT01852942
Status:
COMPLETED
Last Update Posted:
2020-12-11
First Post:
2012-02-20
Brief Title:
Reversing Tissue Fibrosis to Improve Immune Reconstitution in HIV
Sponsor:
University of Minnesota
Organization:
University of Minnesota
Study Overview
Official Title:
Reversing Tissue Fibrosis to Improve Immune Reconstitution in HIV
Status:
COMPLETED
Status Verified Date:
2020-11
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 study was designed to test the hypothesis that treatment of HIV infected subjects with losartan an agent with specific anti-inflammatory and anti-fibrotic actions will
1 reverse existing lymphoid tissue fibrosis
2 restore lymphoid tissue architecture
3 increase the number and improve the function of peripheral and lymphatic CD4 T cells
4 decrease levels of systemic immune activation IA
5 decrease size of the HIV reservoir and
6 be safe and well tolerated
1 reverse existing lymphoid tissue fibrosis
2 restore lymphoid tissue architecture
3 increase the number and improve the function of peripheral and lymphatic CD4 T cells
4 decrease levels of systemic immune activation IA
5 decrease size of the HIV reservoir and
6 be safe and well tolerated
Detailed Description:
This is a randomized double-blind placebo-controlled trial of 50 HIV-1 infected individuals on stable ART randomized in a 11 ratio to losartan 50 mg orally daily titrated to 100 mg daily vs placebo for 30 months We plan to enroll a total of 63 HIV infected subjects to ensure that 50 complete the protocol All HIV infected subjects will undergo biopsies of inguinal lymph node LN and gut associated lymphatic tissue GALT for primary endpoint analysis at baseline 12 and 30 months after study enrollment Blood will be collected at least quarterly throughout the study and an intensive blood pharmacokinetic PK study will be conducted at month 1 All HIV infected subjects will be vaccinated with the quadrivalent human papillomavirus HPV vaccine at months 23 25 and 295 to measure immune function 5 HIV uninfected control subjects will also be enrolled
The primary endpoint is to determine the impact of losartan on lymphoid tissue fibrosis in HIV infected ART treated adults This will be determined by measuring the amount of collagen deposition in lymphoid tissues and the integrity of the FRCn using immunohistochemistry IHC and quantitative image analysis QIA
The primary endpoint is to determine the impact of losartan on lymphoid tissue fibrosis in HIV infected ART treated adults This will be determined by measuring the amount of collagen deposition in lymphoid tissues and the integrity of the FRCn using immunohistochemistry IHC and quantitative image analysis QIA
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 |
|---|---|---|---|
| U01AI105872 | NIH | Hennepin County Medical Center | httpsreporternihgovquickSearchU01AI105872 |
| 13-3613 | OTHER | None | None |