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Clinical Trials/NCT00772720
NCT00772720UnknownPhase 1

Study on the Effects of Raltegravir (Isentress®) on Lipid and Carbohydrate Metabolism and Mitochondrial Function in Healthy Volunteers

Hospital Clinic of Barcelona1 site in 1 country14 target enrollmentStarted: March 1, 2010Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Enrollment
14
Locations
1
Primary Endpoint
Blood levels of total cholesterol
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Healthy male.
  • •age between 18 and
  • •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.

Exclusion Criteria

  • •Severe psychiatric disease.
  • •Dyslipemia.
  • •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

Outcomes

Primary Outcomes

Blood levels of total cholesterol

Time Frame: 7 days

Secondary Outcomes

  • Changes in HDL, LDL and triglycerides(7 days)
  • Oral glucose tolerance test(7 days)
  • Mitochondrial DNA levels(7 days)

Investigators

Sponsor Class
Other

Study Sites (1)

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