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Study of Enfuvirtide in HIV-Positive Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00086710
First Posted: July 13, 2004
Last Update Posted: July 1, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Hoffmann-La Roche
Information provided by:
Trimeris
July 8, 2004
July 13, 2004
July 1, 2005
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No Changes Posted
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Study of Enfuvirtide in HIV-Positive Subjects
An Open-label, Randomized, Cross-over Study in HIV-Positive Subjects to Determine and Compare the Single-dose Pharmacokinetics of Enfuvirtide after a Single 90 mg SC Administration
A total of 26 patients will be admitted to the clinic where they will be dosed with each injection device. There will be a 7-day washout between doses and a 7-10 day follow-up period.
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Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • HIV Infections
  • AIDS
Drug: Fuzeon
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
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Inclusion Criteria:

Exclusion Criteria:

Sexes Eligible for Study: All
18 Years to 64 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00086710
T20-405
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Trimeris
Hoffmann-La Roche
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Trimeris
April 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP