Study Stopped
Insufficient enrollment
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
1 other identifier
interventional
8
1 country
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jul 2004
Shorter than P25 for phase_4
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 21, 2004
CompletedFirst Submitted
Initial submission to the registry
January 7, 2005
CompletedFirst Posted
Study publicly available on registry
January 10, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 16, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
July 16, 2005
CompletedJune 20, 2017
December 1, 2005
12 months
January 7, 2005
June 19, 2017
Conditions
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Unknown Facility
Hobson City, Alabama, 36201, United States
Unknown Facility
Los Angeles, California, 90033, United States
Unknown Facility
Los Angeles, California, 90036, United States
Unknown Facility
Washington D.C., District of Columbia, 20007, United States
Unknown Facility
Washington D.C., District of Columbia, 20009, United States
Unknown Facility
Orlando, Florida, 32803, United States
Unknown Facility
Atlanta, Georgia, 30308, United States
Unknown Facility
Macon, Georgia, 31201, United States
Unknown Facility
Chicago, Illinois, 60612, United States
Unknown Facility
Chicago, Illinois, 60657, United States
Unknown Facility
Baltimore, Maryland, 21201, United States
Unknown Facility
Boston, Massachusetts, 02215-3318, United States
Unknown Facility
Jackson, Mississippi, 39216-4505, United States
Unknown Facility
St Louis, Missouri, 63139, United States
Unknown Facility
Newark, New Jersey, 07103, United States
Unknown Facility
New York, New York, 10011, United States
Unknown Facility
New York, New York, 10016, United States
Unknown Facility
Huntersville, North Carolina, 28078, United States
Unknown Facility
Dallas, Texas, 75246, United States
Unknown Facility
Houston, Texas, 77004, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 7, 2005
First Posted
January 10, 2005
Study Start
July 21, 2004
Primary Completion
July 16, 2005
Study Completion
July 16, 2005
Last Updated
June 20, 2017
Record last verified: 2005-12