Double Protease Inhibitor to Darunavir Switch Study

HIV Infections Clinical Trial

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

Clinical Trial 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)

Clinical Trial 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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• HIV Infections

• NCT number: NCT00531557
• Study type: Interventional
• Source: St Stephens Aids Trust
• Status: Completed
• Phase: Phase 4
• Start date: September 2007
• Completion date: November 2008