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

Hospital Clinic of Barcelona14 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Healthy Volunteers

Interventions

raltegravirDRUG

raltegravir 400 mg BID for 7 days

PlaceboDRUG

Placebo BID for 7 days

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Hospital Clinic

Barcelona, Catalonia, Spain

RECRUITING

Outcomes

Primary Outcomes

Blood levels of total cholesterol

Time frame: 7 days

Secondary Outcomes

Changes in HDL, LDL and triglycerides

Time frame: 7 days

Oral glucose tolerance test

Time frame: 7 days

Mitochondrial DNA levels

Time frame: 7 days

Data from ClinicalTrials.gov

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