Raltegravir Insulin Sensitivity Study
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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 | Intervention | Phase |
---|---|---|
HIV Infections |
Drug: Raltegravir then lopinavir/ritonavir Drug: Lopinavir/ritonavir then raltegravir |
Phase 1 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: 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. |
- Change from baseline in insulin sensitivity by euglycaemic clamp method [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
- Change from baseline in serum levels of fasting cholesterol, triglycerides [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Enrollment: | 18 |
Study Start Date: | October 2007 |
Study Completion Date: | August 2008 |
Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
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
|
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
|
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
![](https://webarchive.library.unt.edu/web/20130309095251im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
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
![](https://webarchive.library.unt.edu/web/20130309095251im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
United Kingdom | |
St Stephens Centre, Chelsea & Westminster Hospital | |
London, United Kingdom |
Principal Investigator: | Greame Moyle | Chelsea & Westminser Healthcare NHS Trust |
![](https://webarchive.library.unt.edu/web/20130309095251im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
No publications provided
Responsible Party: | Dr Graeme Moyle, St Stephen's AIDS Trust |
ClinicalTrials.gov Identifier: | NCT00531999 History of Changes |
Other Study ID Numbers: | SSAT023 |
Study First Received: | September 18, 2007 |
Last Updated: | August 13, 2010 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by St Stephens Aids Trust:
Raltegravir Euglycaemic clamp healthy volunteer |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Insulin Resistance Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Hyperinsulinism Glucose Metabolism Disorders |
Metabolic Diseases Ritonavir Lopinavir HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on March 07, 2013