Raltegravir Insulin Sensitivity Study

HIV Infections Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00531999
• Other study ID #: SSAT023
• Status: Completed
• Phase: Phase 1
• First received: September 18, 2007
• Last updated: August 13, 2010
• Start date: October 2007
• Est. completion date: August 2008

Study information

• Verified date: August 2010
• Source: St Stephens Aids Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Subjects must have documented negative HIV serology by ELISA and P24 antigen

• Subjects must be clinically well males aged between 18 to 60 years

• Fasting blood glucose, total cholesterol and triglycerides within normal limits

• Hepatic transaminases (AST and ALT) = 3 × upper limit of normal (ULN)

• Adequate hematologic function (absolute neutrophil count = 1,000/mm3; platelets = 50,000/mm3; hemoglobin = 8.0 g/dL)

• Serum amylase = 1.5 × ULN (subjects with serum amylase > 1.5 × ULN will remain eligible if pancreatic lipase is = 1.5 × ULN)

• Sexually active males must use condoms during the course of the study

• Life expectancy = 1 year

• Willing and able to provide informed consent

Exclusion Criteria:

• Subjects with a waist hip ratio > 0.97 or BMI > 28 kg/m2 will be excluded

• Acute or chronic hepatitis B infection (determined by positive hepatitis B surface antigen result at the screening visit)

• Acute or chronic hepatitis C infection (determined by positive hepatitis C antibody result at the screening visit)

• Other metabolic syndrome or disease process in the opinion of the investigator likely to cause marked disturbance in glucose and lipid homeostasis including hypertension

• Receiving on-going therapy with any of the following:

• Metabolically active medications

• Any lipid-lowering medication

• Hormonal agents (oestrogens or androgens)

• Glucocorticoids

• Beta-blockers

• Thiazide diuretics

• Thyroid preparations

• Psychotropic agents

• Anabolic steroids

• Megestrol acetate

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• HIV Infections

Intervention

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
• 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

Locations

Country	Name	City	State
United Kingdom	St Stephens Centre, Chelsea & Westminster Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
St Stephens Aids Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in insulin sensitivity by euglycaemic clamp method		2 weeks	No
Secondary	Change from baseline in serum levels of fasting cholesterol, triglycerides		2 weeks	No