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

• Status: Unknown status
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hospital Clinic of Barcelona
• Treatments: Raltegravir Potassium

Criteria

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