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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00772720 |
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Date of registration:
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14/10/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effects of Raltegravir (Isentress®) on Lipid and Carbohydrate Metabolism and Mitochondrial Function in Healthy Volunteers
RALMET-VOLHCB |
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Scientific title:
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Study on the Effects of Raltegravir (Isentress®) on Lipid and Carbohydrate Metabolism and Mitochondrial Function in Healthy Volunteers |
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Date of first enrolment:
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March 2010 |
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Target sample size:
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14 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00772720 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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Spain
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Contacts
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Name:
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Esteban Martinez, MD |
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Address:
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Telephone:
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0034932275400 |
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Email:
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esteban@fundsoriano.es |
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Affiliation:
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Healthy Volunteers
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Intervention(s)
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Drug: Placebo
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Drug: raltegravir
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Primary Outcome(s)
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Blood levels of total cholesterol
[Time Frame: 7 days]
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Secondary Outcome(s)
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Changes in HDL, LDL and triglycerides
[Time Frame: 7 days]
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Mitochondrial DNA levels
[Time Frame: 7 days]
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Oral glucose tolerance test
[Time Frame: 7 days]
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Secondary ID(s)
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EUDRACT #: 2008- 003288-37
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RALMET-VOLHCB
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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