Ignite Creation Date:
2024-05-06 @ 2:21 AM
Last Modification Date:
2024-10-26 @ 11:17 AM
Study NCT ID:
NCT02023450
Status:
UNKNOWN
Last Update Posted:
2014-09-08
First Post:
2013-12-23
Brief Title:
Testing of HIV Protease Inhibitors to Suppress Inflammation and Improve Cardio Pulmonary Hemodynamics in Subjects With Pulmonary Arterial Hypertension
Sponsor:
The Third Xiangya Hospital of Central South University
Organization:
The Third Xiangya Hospital of Central South University
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2014-09
Last Known Status:
RECRUITING
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:
Study RationaleThere is recent evidence that HIV protease inhibitors HIV-PI can improve pulmonary hemodynamics in experimental models of pulmonary arterial hypertension PAH There is also experimental evidence that both TLR4 and high mobility group box 1 HMGB1 participate in the pathogenesis of experimental pulmonary hypertension A recent high throughput screen for inhibitors of HMGB1 induced macrophage activation yielded HIV-protease inhibitors PIs as potent inhibitors of HMGB1 induced cytokine production Based on the experimental evidence we propose a trial to determine whether HIV-PIs will alter the pathobiology of PAH
Study ObjectivesThe main objective of this study is to determine whether saquinavir and ritonavir SQVRIT which have a well-characterized safety profile in humans will reduce bio markers of inflammation and pulmonary artery pressures in patients with PAH
Study HypothesisWe hypothesize that the HIV-PI SQVRIT will reduce circulating parameters of inflammation including HMGB1 IL1-beta IL-6 IL-8 IL-10 TNF-alpha and CRP Our end points will be changes in these parameters from baseline over the duration of the studyWe hypothesize that treatment with SQVRIT will reduce pulmonary arteryPA pressure of patients with PAH as measured by echocardiography
Study DesignThis is a single center open label phase 0 study to evaluate the effect of SQV RIT in patients with IPAH Subjects with IPAHN20 will be enrolled into a study which will be divided into 3 cohorts and entail the administration of HIV protease inhibitors in three doses The first cohort n3 will receive a starting dose of SQV 03 mgkg twice daily in combination with RIT 003 mgkg twice daily If the first dose is well-tolerated the second cohort n 3 with IPAH will be given doses of SQV 3 mgkg and RIT 03 mgkg twice daily If the second dose is well-tolerated the last cohort n 14 with IPAH will be given doses of SQV 15 mgkg and RIT 15 mgkg twice daily
Study ObjectivesThe main objective of this study is to determine whether saquinavir and ritonavir SQVRIT which have a well-characterized safety profile in humans will reduce bio markers of inflammation and pulmonary artery pressures in patients with PAH
Study HypothesisWe hypothesize that the HIV-PI SQVRIT will reduce circulating parameters of inflammation including HMGB1 IL1-beta IL-6 IL-8 IL-10 TNF-alpha and CRP Our end points will be changes in these parameters from baseline over the duration of the studyWe hypothesize that treatment with SQVRIT will reduce pulmonary arteryPA pressure of patients with PAH as measured by echocardiography
Study DesignThis is a single center open label phase 0 study to evaluate the effect of SQV RIT in patients with IPAH Subjects with IPAHN20 will be enrolled into a study which will be divided into 3 cohorts and entail the administration of HIV protease inhibitors in three doses The first cohort n3 will receive a starting dose of SQV 03 mgkg twice daily in combination with RIT 003 mgkg twice daily If the first dose is well-tolerated the second cohort n 3 with IPAH will be given doses of SQV 3 mgkg and RIT 03 mgkg twice daily If the second dose is well-tolerated the last cohort n 14 with IPAH will be given doses of SQV 15 mgkg and RIT 15 mgkg twice daily
Detailed Description:
None
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