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Raltegravir Insulin Sensitivity Study

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ClinicalTrials.gov Identifier: NCT00531999
Recruitment Status : Completed
First Posted : September 19, 2007
Last Update Posted : August 16, 2010
Sponsor:
Information provided by:
St Stephens Aids Trust

Study Description
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Brief 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).


Condition or disease Intervention/treatment Phase
HIV Infections Drug: Raltegravir then lopinavir/ritonavir Drug: Lopinavir/ritonavir then raltegravir Phase 1

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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.
Study Start Date : October 2007
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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
 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
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.
 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


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in insulin sensitivity by euglycaemic clamp method [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. Change from baseline in serum levels of fasting cholesterol, triglycerides [ Time Frame: 2 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00531999


Locations
United Kingdom
St Stephens Centre, Chelsea & Westminster Hospital
London, United Kingdom
Sponsors and Collaborators
St Stephens Aids Trust
Investigators
Principal Investigator: Greame Moyle Chelsea & Westminser Healthcare NHS Trust
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Dr Graeme Moyle, St Stephen's AIDS Trust
ClinicalTrials.gov Identifier: NCT00531999     History of Changes
Other Study ID Numbers: SSAT023
First Posted: September 19, 2007    Key Record Dates
Last Update Posted: August 16, 2010
Last Verified: August 2010

Keywords provided by St Stephens Aids Trust:
Raltegravir
Euglycaemic clamp
healthy volunteer

Additional relevant MeSH terms:
HIV Infections
Insulin Resistance
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Ritonavir
Lopinavir
 Raltegravir Potassium
Insulin
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
HIV Integrase Inhibitors
Integrase Inhibitors
Hypoglycemic Agents