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Study of Enfuvirtide in HIV-Positive Subjects

Primary Purpose

HIV Infections, AIDS

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Fuzeon
Sponsored by
Trimeris
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: - Exclusion Criteria: -

Sites / Locations

  • SFBC

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 8, 2004
Last Updated
June 23, 2005
Sponsor
Trimeris
Collaborators
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT00086710
Brief Title
Study of Enfuvirtide in HIV-Positive Subjects
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2004
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Trimeris
Collaborators
Hoffmann-La Roche

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, AIDS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Fuzeon

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Exclusion Criteria: -
Facility Information:
Facility Name
SFBC
City
Miami
State/Province
Florida
ZIP/Postal Code
33181
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study of Enfuvirtide in HIV-Positive Subjects

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