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Sponsored by: |
St Stephens Aids Trust |
---|---|
Information provided by: | St Stephens Aids Trust |
ClinicalTrials.gov Identifier: | NCT00531999 |
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 I |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Active Control, Parallel Assignment, Pharmacodynamics Study |
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. |
Estimated Enrollment: | 16 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | October 2008 |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
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
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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
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2: Active Comparator
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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
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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
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Receiving on-going therapy with any of the following:
United Kingdom | |
St Stephens Centre, Chelsea & Westminster Hospital | |
london, United Kingdom |
Principal Investigator: | Greame Moyle | Chelsea & Westminser Healthcare NHS Trust |
Responsible Party: | St Stephen's AIDS Trust ( Dr Graeme Moyle ) |
Study ID Numbers: | SSAT023 |
Study First Received: | September 18, 2007 |
Last Updated: | July 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00531999 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Raltegravir Euglycaemic clamp healthy volunteer |
Virus Diseases Sexually Transmitted Diseases, Viral Lopinavir Ritonavir HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Healthy Retroviridae Infections Insulin Immunologic Deficiency Syndromes Inflammation |
Anti-Infective Agents RNA Virus Infections HIV Protease Inhibitors Slow Virus Diseases Anti-HIV Agents Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors |
Infection Antiviral Agents Pharmacologic Actions Protease Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections |