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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
Sponsor:
Information provided by:
Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT00772720
First received: October 14, 2008
Last updated: March 30, 2010
Last verified: March 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Healthy Volunteers
 Drug: raltegravir
Drug: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study on the Effects of Raltegravir (Isentress®) on Lipid and Carbohydrate Metabolism and Mitochondrial Function in Healthy Volunteers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospital Clinic of Barcelona:

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: 14
Study Start Date: March 2010
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: raltegravir
    raltegravir 400 mg BID for 7 days
    Other Name: Isentress
    Drug: Placebo
    Placebo BID for 7 days
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00772720

Locations
Spain
Hospital Clinic Recruiting
Barcelona, Catalonia, Spain, 08036
Contact: Esteban Martinez, MD     0034932275400 ext 3310     esteban@fundsoriano.es    
Sponsors and Collaborators
Hospital Clinic of Barcelona
  More Information

No publications provided

Responsible Party: Jose M Gatell, Hospital Clinic
ClinicalTrials.gov Identifier: NCT00772720     History of Changes
Other Study ID Numbers: RALMET-VOLHCB, EUDRACT #: 2008- 003288-37
Study First Received: October 14, 2008
Last Updated: March 30, 2010
Health Authority: Spain: Spanish Agency of Medicines

ClinicalTrials.gov processed this record on May 16, 2013