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OpenTrials
Completed

NCT Number: NCT00657761

Metabolic Effects of Enfuvirtide in Healthy Volunteers

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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Clinic

Barcelona, 08036, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enfuvirtide

Drug

90 mg/12h sc for 7 days

Placebo

Drug

0.9% saline solution/12h sc for 7 days

Primary outcomes

  1. Change in fasting plasma total cholesterol

    Time frame: 6 weeks

Secondary outcomes

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

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Collaborators

  • Hoffmann-La Roche

Registry information

Official study title

Effect of Enfuvirtide on Lipid and Glucose Metabolism and Mitochondrial Function in Healthy Volunteers

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Apr 14, 2008
Registry last updated
Apr 14, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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