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
  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:


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
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

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 October 01, 2014