Study of Enfuvirtide in HIV-Positive Subjects

This study has been completed.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
Trimeris
ClinicalTrials.gov Identifier:
NCT00086710
First received: July 8, 2004
Last updated: June 23, 2005
Last verified: April 2004

July 8, 2004
June 23, 2005
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Complete list of historical versions of study NCT00086710 on ClinicalTrials.gov Archive Site
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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
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: 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:

-

Both
18 Years to 64 Years
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