drugset / Trial / NCT00531557

Double Protease Inhibitor to Darunavir Switch Study

NCT00531557

Phase 4 Completed 12 enrolled St Stephens Aids Trust
NaSingle-groupOpen-label

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)

Timeline

Start
2007-09
Primary completion
2008-11
Completion
2008-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Darunavir Small molecule 600 mg Oral
Background Ritonavir Other / unclassified 100 mg Oral