Tenofovir DF + Efavirenz (TDF+EFV) Versus Tenofovir DF + Efavirenz + Lamivudine (TDF+EFV+3TC) Maintenance Regimen in Virologically Controlled Patients: COOL Trial
NCT ID: NCT00643968
Last Updated: 2008-06-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
140 participants
INTERVENTIONAL
2003-03-31
2005-09-30
Brief Summary
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Main Secondary objectives:
Comparison of the two arms for genotypic resistance profile in case of virological failure
CD4 changes from baseline
Evolution of the lipid profile and morphological changes in fat distribution, and safety
Efficacy and genotypic profile data, results of lipid markers, morphological changes and main biological parameters
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
NONE
Study Groups
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1
TDF+EFV
EFV+TDF
2
TDF+3TC+EFV
EFV+3TC+TDF
Interventions
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EFV+TDF
EFV+3TC+TDF
Eligibility Criteria
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Inclusion Criteria
* HIV-1 RNA \< 50 c/mL ≥ 6 months
* No HAART failure history
Exclusion Criteria
* No CD4+ cell count criteria
* No significant laboratory or clinical abnormalities
* Creatinine Clearance \> 60 mL/min
18 Years
70 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Gilead Sciences, Inc.
Principal Investigators
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Aldo Trylesinski, MD
Role: PRINCIPAL_INVESTIGATOR
Gilead Sciences
Locations
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France and French West Indies
Paris, , France
Countries
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Related Links
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Other Identifiers
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GS-FR-104-1016
Identifier Type: -
Identifier Source: org_study_id