NCT00531999

Raltegravir Insulin Sensitivity Study

An Open Label Study of the Impact on Insulin Sensitivity, Lipid Profile and Vascular Inflammation by Treatment With Lopinavir / Ritonavir (400 / 100 mg Twice Daily) or Raltegravir 400 mg Twice Daily in HIV Negative Male Volunteers.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: St Stephens Aids Trust · Academic / Other
• Sex: Male
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to look at the effects of two different HIV medications on the body's response to insulin (a hormone that regulates blood sugar levels). This will be done using a method called the 'euglycaemic clamp' The study will also investigate the effects of these drugs on blood fats and on circulating markers in the blood stream related to blood vessels (vascular inflammation markers).

Detailed description

Subjects will undergo four euglycaemic clamp procedures in order to determine the extent of glucose disposal. The first clamp will be performed prior to the commencement of the first study drug administration, the second one following two weeks of study drug, the third after a two week washout period, prior to commencement of second study drug administration and the fourth after two weeks of the second study drug

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	Raltegravir then lopinavir/ritonavir	raltegravir 400mg twice daily for first 14 days of study lopinavir/ritonavir 400/100mg twice daily for last 14 days of study
DRUG	Lopinavir/ritonavir then raltegravir	lopinavir/ritonavir 400 mg twice daily for the first 14 days of the study raltegravir 400mg twice daily for the last 14 days of the study

Timeline

• Start date: 2007-10-01
• Primary completion: 2008-08-01
• Completion: 2008-08-01
• First posted: 2007-09-19
• Last updated: 2010-08-16

Locations

1 site across 1 country: United Kingdom