NCT00772720

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
14

participants targeted

Target at below P25 for phase_1 healthy-volunteers

Timeline
Completed

Started Mar 2010

Longer than P75 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 14, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 15, 2008

Completed
1.4 years until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

March 31, 2010

Status Verified

March 1, 2010

Enrollment Period

1 year

First QC Date

October 14, 2008

Last Update Submit

March 30, 2010

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • Blood levels of total cholesterol

    7 days

Secondary Outcomes (3)

  • Changes in HDL, LDL and triglycerides

    7 days

  • Oral glucose tolerance test

    7 days

  • Mitochondrial DNA levels

    7 days

Interventions

raltegravirDRUG

raltegravir 400 mg BID for 7 days

Also known as: Isentress
PlaceboDRUG

Placebo BID for 7 days

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinic

Barcelona, Catalonia, 08036, Spain

RECRUITING

MeSH Terms

Interventions

Raltegravir Potassium

Intervention Hierarchy (Ancestors)

PyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 14, 2008

First Posted

October 15, 2008

Study Start

March 1, 2010

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

March 31, 2010

Record last verified: 2010-03

Locations

ES(1)