Effects of Raltegravir (Isentress®) on Lipid and Carbohydrate Metabolism and Mitochondrial Function in Healthy Volunteers (RALMET-VOLHCB)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Hospital Clinic of Barcelona.
Recruitment status was Recruiting
Information provided by:
Hospital Clinic of Barcelona
First received: October 14, 2008
Last updated: March 30, 2010
Last verified: March 2010
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.
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
||Study on the Effects of Raltegravir (Isentress®) on Lipid and Carbohydrate Metabolism and Mitochondrial Function in Healthy Volunteers
Primary Outcome Measures:
- Blood levels of total cholesterol [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Changes in HDL, LDL and triglycerides [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
- Oral glucose tolerance test [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
- Mitochondrial DNA levels [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||March 2011 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years to 45 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Healthy male.
- age between 18 and 45.
- BMI between 19 and 25 kg/m2
- Normal physical exam.
- Blood analysis without relevant findings.
- Negative serology for hepatitis B, Hepatitis C and HIV.
- Negative urine test for abuse drugs.
- Severe psychiatric disease.
- Alcohol intake above 30 g per day.
- Xanthine intake above 5 coffee cup -equivalents per day
- Use of any drugs in the last month
- Participation in other trials in the last 3 months
- Diseases capable to modify drug ADME
- Drug allergy
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00772720
|Barcelona, Catalonia, Spain, 08036 |
|Contact: Esteban Martinez, MD 0034932275400 ext 3310 firstname.lastname@example.org |
Hospital Clinic of Barcelona
No publications provided
ClinicalTrials.gov processed this record on October 23, 2014
||Jose M Gatell, Hospital Clinic
History of Changes
|Other Study ID Numbers:
||RALMET-VOLHCB, EUDRACT #: 2008- 003288-37
|Study First Received:
||October 14, 2008
||March 30, 2010
||Spain: Spanish Agency of Medicines