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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. The completion date has passed and the status has not been verified in more than two years.
Verified March 2010 by Hospital Clinic of Barcelona.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00772720
First Posted: October 15, 2008
Last Update Posted: March 31, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hospital Clinic of Barcelona
  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
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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:


Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • Blood levels of total cholesterol [ Time Frame: 7 days ]

Secondary Outcome Measures:
  • Changes in HDL, LDL and triglycerides [ Time Frame: 7 days ]
  • Oral glucose tolerance test [ Time Frame: 7 days ]
  • Mitochondrial DNA levels [ Time Frame: 7 days ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Jose M Gatell, Hospital Clinic
ClinicalTrials.gov Identifier: NCT00772720     History of Changes
Other Study ID Numbers: RALMET-VOLHCB
EUDRACT #: 2008- 003288-37
First Submitted: October 14, 2008
First Posted: October 15, 2008
Last Update Posted: March 31, 2010
Last Verified: March 2010

Additional relevant MeSH terms:
Raltegravir Potassium
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
HIV Integrase Inhibitors
Integrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action