Double Protease Inhibitor to Darunavir Switch Study
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)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
|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.|
- The proportion of subjects maintaining viral suppression (< 50 copies/mL) [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
- • CD4+ count at screening, baseline, weeks 4, 12, 24, 36 and at the end of the study period • Viral suppression below 50 copies/mL and below 500 copies/mL at 4, 12, 24, 36 and 48 weeks • Laboratory abnormalities and adverse events at baseline, 4 [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||September 2007|
|Study Completion Date:||November 2008|
|Primary Completion Date:||November 2008 (Final data collection date for primary outcome measure)|
Darunavir 600mg BID with ritonavir 100mg BID administered orally.
|Drug: Darunavir ritonavir|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00531557
|St Stephens Centre, Chelsea & Westminster Hospital|
|London, United Kingdom|
|Principal Investigator:||Mark Nelson||Chelsea & Westminser Healthcare NHS Trust|