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Study of Enfuvirtide in HIV-Positive Subjects

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

Condition Intervention Phase
HIV Infections AIDS Drug: Fuzeon Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Trimeris:

Estimated Enrollment: 26

Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00086710

United States, Florida
Miami, Florida, United States, 33181
Sponsors and Collaborators
Hoffmann-La Roche
  More Information Identifier: NCT00086710     History of Changes
Other Study ID Numbers: T20-405
Study First Received: July 8, 2004
Last Updated: June 23, 2005

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
HIV Fusion Inhibitors
Viral Fusion Protein Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents processed this record on September 18, 2017