Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 6:52 PM
Ignite Modification Date:
2025-12-24 @ 6:52 PM
NCT ID:
NCT00531557
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 body's 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 DRV/r.
Routine safety bloods to include haematology and biochemistry (including U\&E, 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 DRV/r and the second one following administration of DRV/r for 4 weeks.
Study:
NCT00531557
Study Brief:
Protocol Section:
NCT00531557