Ignite Creation Date:
2024-05-05 @ 6:44 PM
Last Modification Date:
2024-10-26 @ 9:36 AM
Study NCT ID:
NCT00531557
Status:
COMPLETED
Last Update Posted:
2010-08-16
First Post:
2007-09-18
Brief Title:
Double Protease Inhibitor to Darunavir Switch Study
Sponsor:
St Stephens Aids Trust
Organization:
St Stephens Aids Trust
Study Overview
Official Title:
Phase IV Cohort Study Assessing Feasibility of Substituting Double Ritonavir-boosted Protease Inhibitors With Ritonavir-boosted Darunavir in HIV-infected Individuals With Viral Suppression on Highly Active Antiretroviral Therapy
Status:
COMPLETED
Status Verified Date:
2010-08
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:
The purpose of the study is to study the effects of switching from an antiretroviral combination that includes two ritonavir boosted protease inhibitors to replacement of these two protease inhibitors with a new protease inhibitor called Darunavir also boosted with ritonavir
The study will investigate the effect of the switch on viral load the levels of the HIV virus in the blood on immunological parameters CD4 count and on other safety parameters and also on quality of life
In a subgroup of patients the impact of the switch on the bodys response to the hormone insulin will also be measured Euglycaemic clamp sub group
The study will investigate the effect of the switch on viral load the levels of the HIV virus in the blood on immunological parameters CD4 count and on other safety parameters and also on quality of life
In a subgroup of patients the impact of the switch on the bodys response to the hormone insulin will also be measured Euglycaemic clamp sub group
Detailed Description:
HIV-RNA and CD4 cell count to monitor virological and immunological response on switching to DRVr
Routine safety bloods to include haematology and biochemistry including UE fasted glucose and insulin liver function test fasting cholesterol and triglycerides and serum lactate measurements
Quality of life EuroQOL questionnaires at baseline and throughout the study to evaluate quality of life in the continued treatment treatment switch arms
A sub group of 10 patients will undergo two euglycaemic clamp procedures in order to determine the extent of glucose disposal The first clamp will be performed prior to the switching from a double boosted PI therapy to DRVr and the second one following administration of DRVr for 4 weeks
Routine safety bloods to include haematology and biochemistry including UE fasted glucose and insulin liver function test fasting cholesterol and triglycerides and serum lactate measurements
Quality of life EuroQOL questionnaires at baseline and throughout the study to evaluate quality of life in the continued treatment treatment switch arms
A sub group of 10 patients will undergo two euglycaemic clamp procedures in order to determine the extent of glucose disposal The first clamp will be performed prior to the switching from a double boosted PI therapy to DRVr and the second one following administration of DRVr for 4 weeks
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