A 48 Week Study Comparing Treatment With Saquinavir + Lopinavir/Ritonavir in Combination With Enfuvirtide HAART Versus Saquinavir +... | NCT00100984 | Trialant
TerminatedInterventionalPhase 4Updated Jun 20, 2017
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
ClinicalTrials.gov ID
NCT00100984
Lead Sponsor
Hoffmann-La RocheINDUSTRY
Overall Status
Terminated
Study Type
Interventional
Phase
Phase 4
Enrollment
8Actual
Last Update Posted
Jun 20, 2017Actual
Start Date
Jul 21, 2004Actual
Primary Completion Date
Jul 16, 2005Actual
Completion Date
Jul 16, 2005Actual
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.
HIV Infection
FUZEON [enfuvirtide]
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
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
Primary Purpose
Treatment
Allocation
Randomized
No central contacts
There are no central contacts for this study.
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Hobson City, Alabama 36201, United States
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Los Angeles, California 90033, United States
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Los Angeles, California 90036, United States
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Washington D.C., District of Columbia 20007, United States
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Washington D.C., District of Columbia 20009, United States