Metabolic Effects of Enfuvirtide in Healthy Volunteers | NCT00657761

Studies
Metabolic Effects of Enfuvirtide in Healthy Volunteers

NCT00657761

Sponsor

Hospital Clinic of Barcelona

Status

Completed

Last Update Posted

Apr 14, 2008Estimated

Enrollment

15Actual

Phase

Phase 4

Conditions

HIV Infections

Interventions

Enfuvirtide
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 #: 2005-002018-39

Status Module

Record Verification Date

Apr 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2005

Primary Completion Date

Mar 2006Actual

Completion Date

Mar 2006Actual

First Submitted Date

Apr 8, 2008

First Submission Date that Met QC Criteria

Apr 8, 2008

First Posted Date

Apr 14, 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

Apr 8, 2008

Last Update Posted Date

Apr 14, 2008Estimated

Name	Class
Hoffmann-La Roche	INDUSTRY

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

The metabolic effects of T-20 are not completely known, since the drug is used in combination with other antiretroviral agents. A short-term study in healthy volunteers, with a double-blind crossover design vs. placebo will illustrate if there may be some direct metabolic effects without the influence of HIV infection and the concurrent use of other drugs.

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Saline solution 0.9% sc/12h for 7 days	Drug: Placebo
Enfuvirtide	Experimental	Enfuvirtide 90 mg/12h sc for 7 days	Drug: Enfuvirtide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Enfuvirtide	Drug	90 mg/12h sc for 7 days	Enfuvirtide
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in fasting plasma total cholesterol		6 weeks

Secondary Outcomes

Measure	Description	Time Frame
Changes in LDL- and HDL- cholesterol, triglycerides, oral glucose tolerance test, lactate and mt-DNA		6 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy adult males
BMI between 19-24.9 kg/m2
No active concomitant clinical conditions
Negative HIV, HBV and HCV serologies
Negative abuse drug urine test

Exclusion Criteria:

Prior psychiatric illness
Prior dyslipemia
Alcohol consumption > 30g/day
Caffeine consumption > 5 units/day
Current smoker
Known drug allergies
Participation in other drug trials in the previous 3 months
No medications in the previous 30 days

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

Name	Affiliation	Role
Neus Riba, MD	Hospital Clinic of Barcelona	Principal Investigator

Locations

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

Condition Browse Module

MeSH Terms

ID	Term
D015658	HIV Infections

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077560	Enfuvirtide

Ancestor Terms

ID	Term
D010446	Peptide Fragments
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D015700	HIV Envelope Protein gp41

Browse Leaves

Not provided

Browse Branches

Not provided