Effects of Raltegravir (Isentress®) on Lipid and Carbohyd... | NCT00772720

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

NCT00772720

Sponsor

Hospital Clinic of Barcelona

Status

Unknown status

Last Update Posted

Mar 31, 2010Estimated

Enrollment

14Estimated

Phase

Phase 1

Conditions

Healthy Volunteers

Interventions

raltegravir
Placebo

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
EUDRACT #: 2008- 003288-37

Status Module

Record Verification Date

Mar 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2010

Primary Completion Date

Mar 2011Estimated

Completion Date

Mar 2011Estimated

First Submitted Date

Oct 14, 2008

First Submission Date that Met QC Criteria

Oct 14, 2008

First Posted Date

Oct 15, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 30, 2010

Last Update Posted Date

Mar 31, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

14Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
raltegravir	Drug	raltegravir 400 mg BID for 7 days		Isentress
Placebo	Drug	Placebo BID for 7 days

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Blood levels of total cholesterol		7 days

Secondary Outcomes

Measure	Description	Time Frame
Changes in HDL, LDL and triglycerides		7 days
Oral glucose tolerance test		7 days
Mitochondrial DNA levels

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

Severe psychiatric disease.
Dyslipemia.
Alcohol intake above 30 g per day.
Smokers
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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Clinic	Recruiting	Barcelona	Catalonia	08036	Spain

Intervention Browse Module

MeSH Terms

ID	Term
D000068898	Raltegravir Potassium

Ancestor Terms

ID	Term
D011760	Pyrrolidinones
D011759	Pyrrolidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided