Status:
TERMINATED
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
Lead Sponsor:
Hoffmann-La Roche
Conditions:
HIV Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 21 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 16 2005
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00100984
Start Date
July 21 2004
End Date
July 16 2005
Last Update
June 20 2017
Active Locations (20)
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1
Hobson City, Alabama, United States, 36201
2
Los Angeles, California, United States, 90033
3
Los Angeles, California, United States, 90036
4
Washington D.C., District of Columbia, United States, 20007