Raltegravir Insulin Sensitivity Study

This study has been completed.
Sponsor:
Information provided by:
St Stephens Aids Trust
ClinicalTrials.gov Identifier:
NCT00531999
First received: September 18, 2007
Last updated: August 13, 2010
Last verified: August 2010

September 18, 2007
August 13, 2010
October 2007
August 2008   (final data collection date for primary outcome measure)
Change from baseline in insulin sensitivity by euglycaemic clamp method [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
 Change from baseline in insulin sensitivity by euglycaemic clamp method [ Time Frame: 2 weeks ]
Complete list of historical versions of study NCT00531999 on ClinicalTrials.gov Archive Site
Change from baseline in serum levels of fasting cholesterol, triglycerides [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
 Change from baseline in serum levels of fasting cholesterol, triglycerides [ Time Frame: 2 weeks ]
Not Provided
Not Provided
 
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.

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).

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

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
HIV Infections
  • 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
  • Active Comparator: 1
    Raltegravir 400 mg twice daily for the first 14 days of the study. Lopinavir/ritonavir 400/100 mg twice daily for the last 14 days of the study
    Intervention: Drug: Raltegravir then lopinavir/ritonavir
  • Active Comparator: 2
    • Lopinavir/ritonavir 400/100 mg twice daily for the first 14 days of the study.
    • Raltegravir 400 mg twice daily for the last 14 days of the study.
    Intervention: Drug: Lopinavir/ritonavir then raltegravir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
August 2008
August 2008   (final data collection date for primary outcome measure)

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
Male
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00531999
SSAT023
No
Dr Graeme Moyle, St Stephen's AIDS Trust
St Stephens Aids Trust
Not Provided
Principal Investigator: Greame Moyle Chelsea & Westminser Healthcare NHS Trust
St Stephens Aids Trust
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP