NCT00657761

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_4 hiv-infections

Timeline
Completed

Started Sep 2005

Shorter than P25 for phase_4 hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 1, 2005

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

April 8, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 14, 2008

Completed
Last Updated

April 14, 2008

Status Verified

April 1, 2008

Enrollment Period

6 months

First QC Date

April 8, 2008

Last Update Submit

April 8, 2008

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

  • Change in fasting plasma total cholesterol

    6 weeks

Secondary Outcomes (1)

  • Changes in LDL- and HDL- cholesterol, triglycerides, oral glucose tolerance test, lactate and mt-DNA

    6 weeks

Study Arms (2)

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

EnfuvirtideDRUG

90 mg/12h sc for 7 days

Enfuvirtide
PlaceboDRUG

0.9% saline solution/12h sc for 7 days

Placebo

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinic

Barcelona, Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Enfuvirtide

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Peptide FragmentsPeptidesAmino Acids, Peptides, and ProteinsHIV Envelope Protein gp41Viral Fusion ProteinsMembrane Fusion ProteinsMembrane ProteinsProteinsHIV AntigensAntigens, ViralViral Proteinsenv Gene Products, Human Immunodeficiency VirusGene Products, envRetroviridae ProteinsHuman Immunodeficiency Virus ProteinsViral Envelope ProteinsViral Structural ProteinsAntigensBiological Factors

Study Officials

  • Neus Riba, MD

    Hospital Clinic of Barcelona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 8, 2008

First Posted

April 14, 2008

Study Start

September 1, 2005

Primary Completion

March 1, 2006

Study Completion

March 1, 2006

Last Updated

April 14, 2008

Record last verified: 2008-04

Locations

ES(1)