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Metabolic Effects of Enfuvirtide in Healthy Volunteers

NCT00657761 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2008-04-14

No results posted yet for this study

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.

Conditions

  • HIV Infections

Interventions

DRUG

Enfuvirtide

90 mg/12h sc for 7 days

DRUG

Placebo

0.9% saline solution/12h sc for 7 days

Sponsors & Collaborators

Principal Investigators

  • Neus Riba, MD · Hospital Clinic of Barcelona

Study Design

Allocation
RANDOMIZED
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2006-03-31
Completion
2006-03-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00657761 on ClinicalTrials.gov