We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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: June 24, 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
  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
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
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Inclusion Criteria:

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00086710


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

ClinicalTrials.gov Identifier: NCT00086710     History of Changes
Other Study ID Numbers: T20-405
First Submitted: July 8, 2004
First Posted: July 13, 2004
Last Update Posted: June 24, 2005
Last Verified: April 2004

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
Enfuvirtide
HIV Fusion Inhibitors
Viral Fusion Protein Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents