Back to resultsA 48 Week Study Comparing Treatment With Saquinavir + Lopinavir/Ritonavir in Combination With Enfuvirtide HAART Versus Saquinavir + Lopinavir/Ritonavir + Other Nucleoside Combinations to See the Efficacy of These Treatments in Patients Infected With HIV-1
Primary Purpose
HIV Infection
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
FUZEON [enfuvirtide]
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infection
Eligibility Criteria
Inclusion Criteria: CD4 cell count greater than 50 cells/mm^3 HIV-1 RNA viral load greater than or equal to 5000 copies/mL Patients must be HIV treatment experienced Patients diagnosed with HIV-1 infection Exclusion Criteria: Female patients must not be able to have children or must be under effective contraceptives Female patients who are pregnant Have taken enfuvirtide and/or T-1249 before Have serious kidney problems Alcohol and/or drug abuse Have had an organ transplant
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00100984
Brief Title
A 48 Week Study Comparing Treatment With Saquinavir + Lopinavir/Ritonavir in Combination With Enfuvirtide HAART Versus Saquinavir + Lopinavir/Ritonavir + Other Nucleoside Combinations to See the Efficacy of These Treatments in Patients Infected With HIV-1
Study Type
Interventional
2. Study Status
Record Verification Date
December 2005
Overall Recruitment Status
Terminated
Why Stopped
Insufficient enrollment
Study Start Date
July 21, 2004 (Actual)
Primary Completion Date
July 16, 2005 (Actual)
Study Completion Date
July 16, 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
The main objective of this study is to compare the safety and efficacy of an enfuvirtide containing regimen to a nucleoside combination regimen. Resistance information will also be collected.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
FUZEON [enfuvirtide]
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
CD4 cell count greater than 50 cells/mm^3
HIV-1 RNA viral load greater than or equal to 5000 copies/mL
Patients must be HIV treatment experienced
Patients diagnosed with HIV-1 infection
Exclusion Criteria:
Female patients must not be able to have children or must be under effective contraceptives
Female patients who are pregnant
Have taken enfuvirtide and/or T-1249 before
Have serious kidney problems
Alcohol and/or drug abuse
Have had an organ transplant
Facility Information:
City
Hobson City
State/Province
Alabama
ZIP/Postal Code
36201
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
City
Washington, D.C.
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
City
Washington, D.C.
State/Province
District of Columbia
ZIP/Postal Code
20009
Country
United States
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215-3318
Country
United States
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216-4505
Country
United States
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63139
Country
United States
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A 48 Week Study Comparing Treatment With Saquinavir + Lopinavir/Ritonavir in Combination With Enfuvirtide HAART Versus Saquinavir + Lopinavir/Ritonavir + Other Nucleoside Combinations to See the Efficacy of These Treatments in Patients Infected With HIV-1
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