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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
History of Changes
  Purpose

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
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: 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:

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Enfuvirtide
U.S. FDA Resources

Further study details as provided by Trimeris:

Estimated Enrollment: 26
  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

-

Exclusion Criteria:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00086710

Locations
United States, Florida
SFBC
Miami, Florida, United States, 33181
Sponsors and Collaborators
Trimeris
Hoffmann-La Roche
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00086710     History of Changes
Other Study ID Numbers: T20-405
Study First Received: July 8, 2004
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
HIV Seropositivity
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
 Slow Virus Diseases
Enfuvirtide
HIV Fusion Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013