Raltegravir Insulin Sensitivity Study

NCT00531999 | Completed Phase 1

• 1 other identifier: SSAT023
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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).

Conditions

HIV Infections

Keywords

Raltegravir; Euglycaemic clamp; healthy volunteer

Outcome Measures

Primary Outcomes (1)

• Change from baseline in insulin sensitivity by euglycaemic clamp method

  2 weeks

Secondary Outcomes (1)

• Change from baseline in serum levels of fasting cholesterol, triglycerides

  2 weeks

Study Arms (2)

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

Drug: Raltegravir then lopinavir/ritonavir

2

ACTIVE COMPARATOR

* 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

Interventions

Raltegravir then lopinavir/ritonavir DRUG

raltegravir 400mg twice daily for first 14 days of study lopinavir/ritonavir 400/100mg twice daily for last 14 days of study

1

Lopinavir/ritonavir then raltegravir DRUG

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

2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St Stephens Aids Trust: lead

Study Sites (1)

St Stephens Centre, Chelsea & Westminster Hospital

London, United Kingdom

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Ritonavir; Lopinavir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidinones; Pyrimidines

Study Officials

• Greame Moyle

  Chelsea & Westminser Healthcare NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 18, 2007
• First Posted: September 19, 2007
• Study Start: October 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: August 16, 2010

Record last verified: 2010-08

Locations

GB (1)