Effects of Raltegravir (Isentress®) on Lipid and Carbohydrate Metabolism and Mitochondrial Function in Healthy Volunteers

Phase 1

• Conditions: Healthy Volunteers

• Registration Number: NCT00772720
• Lead Sponsor: Hospital Clinic of Barcelona

Brief Summary

Raltegravir is the first of a new antiretroviral class. A better profile of metabolic toxicity is expected. In order to better define its effects, without interference with other drugs, a study on healthy volunteers is warranted.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-10-14
• Study First Submitted QC: 2008-10-14
• Study First Posted: 2008-10-15
• Status Verified: 2010-03
• Study Start: 2010-03
• Last Update Submitted: 2010-03-30
• Last Update Posted: 2010-03-31
• Primary Completion: 2011-03
• Study Completion: 2011-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 14

Inclusion Criteria

1. Healthy male.
2. age between 18 and 45.
3. BMI between 19 and 25 kg/m2
4. Normal physical exam.
5. Blood analysis without relevant findings.
6. Negative serology for hepatitis B, Hepatitis C and HIV.
7. Negative urine test for abuse drugs.

Exclusion Criteria

1. Severe psychiatric disease.
2. Dyslipemia.
3. Alcohol intake above 30 g per day.
4. Smokers
5. Xanthine intake above 5 coffee cup -equivalents per day
6. Use of any drugs in the last month
7. Participation in other trials in the last 3 months
8. Diseases capable to modify drug ADME
9. Drug allergy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Blood levels of total cholesterol	7 days

Secondary Outcome Measures

Name	Time	Method
Changes in HDL, LDL and triglycerides	7 days
Oral glucose tolerance test	7 days
Mitochondrial DNA levels	7 days

Trial Locations

Locations (1)

Hospital Clinic; 🇪🇸 Barcelona, Catalonia, Spain