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A Study Comparing the Efficacy and Safety of Once-Daily Fuzeon (Enfuvirtide) Dosing Versus the Currently Recommended Twice-Daily Dosing in Human Immunodeficiency Virus-Type 1 (HIV-1) Infected Patients

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Optimized Background ARVs
enfuvirtide [Fuzeon]
enfuvirtide [Fuzeon]
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: HIV-1 infected adults or adolescents >=16 years of age; HIV-1 RNA >=5000 copies/mL; prior experience or documented resistance to each of the 3 currently available classes of ARV drugs (nucleoside reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors, and protease inhibitors). Exclusion Criteria: history of prior use of Fuzeon or T-1249; female patients who are pregnant or breastfeeding, or who plan to become pregnant during the study; current severe illness; currently taking drugs affecting the immune system, HIV vaccine, or investigational agents for any conditions other than HIV/AIDS.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Viral load.\n\n

Secondary Outcome Measures

CD4 lymphocyte count.
AEs, laboratory abnormalities, local injection site reactions, AIDS-defining events.\n

Full Information

First Posted
August 5, 2004
Last Updated
November 1, 2016
Sponsor
Hoffmann-La Roche
Collaborators
Trimeris
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1. Study Identification

Unique Protocol Identification Number
NCT00089492
Brief Title
A Study Comparing the Efficacy and Safety of Once-Daily Fuzeon (Enfuvirtide) Dosing Versus the Currently Recommended Twice-Daily Dosing in Human Immunodeficiency Virus-Type 1 (HIV-1) Infected Patients
Official Title
A Phase II Open-label, Randomized, Active-controlled Study Comparing the Efficacy and Safety of Once Daily Enfuvirtide Dosing Versus the Currently Recommended Twice Daily Dosing in HIV-1 Infected Treatment-experienced Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
June 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
Collaborators
Trimeris

4. Oversight

5. Study Description

Brief Summary
This study will assess the safety and efficacy of once-daily administration of Fuzeon compared with twice-daily administration in HIV-1 infected patients who have received prior treatment. Patients will also receive an optimized treatment consisting of antiretroviral (ARV) therapy as determined by the treating physician. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Optimized Background ARVs
Intervention Description
As prescribed
Intervention Type
Drug
Intervention Name(s)
enfuvirtide [Fuzeon]
Intervention Description
180mg sc once daily for 48 weeks
Intervention Type
Drug
Intervention Name(s)
enfuvirtide [Fuzeon]
Intervention Description
90mg sc bid for 48 weeks
Primary Outcome Measure Information:
Title
Viral load.\n\n
Time Frame
Week 48
Secondary Outcome Measure Information:
Title
CD4 lymphocyte count.
Time Frame
Week 48
Title
AEs, laboratory abnormalities, local injection site reactions, AIDS-defining events.\n
Time Frame
Throughout study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: HIV-1 infected adults or adolescents >=16 years of age; HIV-1 RNA >=5000 copies/mL; prior experience or documented resistance to each of the 3 currently available classes of ARV drugs (nucleoside reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors, and protease inhibitors). Exclusion Criteria: history of prior use of Fuzeon or T-1249; female patients who are pregnant or breastfeeding, or who plan to become pregnant during the study; current severe illness; currently taking drugs affecting the immune system, HIV vaccine, or investigational agents for any conditions other than HIV/AIDS.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Hobson City
State/Province
Alabama
ZIP/Postal Code
36201
Country
United States
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90022
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34209
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33169
Country
United States
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202-2689
Country
United States
City
Union
State/Province
New Jersey
ZIP/Postal Code
07083
Country
United States
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18102-7017
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 2P4
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
City
Ponce
ZIP/Postal Code
00732
Country
Puerto Rico
City
San Juan
ZIP/Postal Code
00921-3201
Country
Puerto Rico
City
San Juan
ZIP/Postal Code
00935
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
18474492
Citation
Wright D, Rodriguez A, Godofsky E, Walmsley S, Labriola-Tompkins E, Donatacci L, Shikhman A, Tucker E, Chiu YY, Chung J, Rowell L, Demasi R, Graham N, Salgo M. Efficacy and safety of 48 weeks of enfuvirtide 180 mg once-daily dosing versus 90 mg twice-daily dosing in HIV-infected patients. HIV Clin Trials. 2008 Mar-Apr;9(2):73-82. doi: 10.1310/hct0902-73.
Results Reference
derived

Learn more about this trial

A Study Comparing the Efficacy and Safety of Once-Daily Fuzeon (Enfuvirtide) Dosing Versus the Currently Recommended Twice-Daily Dosing in Human Immunodeficiency Virus-Type 1 (HIV-1) Infected Patients

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