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

Hospital Clinic of Barcelona

Status and phase: Unknown; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: raltegravir; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00772720

RALMET-VOLHCB

EUDRACT #: 2008- 003288-37

Details and patient eligibility

About

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.

Enrollment: 14 estimated patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind