Healthy Volunteers
Conditions
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.
Interventions
DRUGraltegravir
raltegravir 400 mg BID for 7 days
DRUGPlacebo
Placebo BID for 7 days
Sponsors
Hospital Clinic of Barcelona
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood levels of total cholesterol | 7 days |
Secondary
| Measure | Time frame |
|---|---|
| Changes in HDL, LDL and triglycerides | 7 days |
| Oral glucose tolerance test | 7 days |
| Mitochondrial DNA levels | 7 days |
Countries
Spain
Outcome results
None listed