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

Healthy Volunteers Clinical Trial

— RALMET-VOLHCB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00772720
• Other study ID #: RALMET-VOLHCB
• Secondary ID: EUDRACT #: 2008-
• Status: Recruiting
• Phase: Phase 1
• First received: October 14, 2008
• Last updated: March 30, 2010
• Start date: March 2010
• Est. completion date: March 2011

Study information

• Verified date: March 2010
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 14
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• raltegravir
raltegravir 400 mg BID for 7 days
• Placebo
Placebo BID for 7 days

Locations

Country	Name	City	State
Spain	Hospital Clinic	Barcelona	Catalonia

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood levels of total cholesterol		7 days	Yes
Secondary	Changes in HDL, LDL and triglycerides		7 days	Yes
Secondary	Oral glucose tolerance test		7 days	Yes
Secondary	Mitochondrial DNA levels		7 days	Yes