- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00643968
Tenofovir DF + Efavirenz (TDF+EFV) Versus Tenofovir DF + Efavirenz + Lamivudine (TDF+EFV+3TC) Maintenance Regimen in Virologically Controlled Patients: COOL Trial (COOL)
Randomized Multicenter Open-Label, Pilot Trial to Evaluate the Efficacy and Safety of Switching HIV-1 Stable Infected Patients Under HAART to a New Once Daily Triple Therapy Combination Including EFV+3TC+TDF Versus a Dual QD Therapy Containing EFV+TDF
Primary objective: Evaluation of the efficacy of TDF+3TC+EFV versus TDF+EFV QD to maintain plasma HIV-1 RNA BLQ (< 50 copies/mL) (c/mL) at 48 weeks (W48)
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
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Paris, France
- France and French West Indies
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Stable HAART ≥ 3 months
- HIV-1 RNA < 50 c/mL ≥ 6 months
- No HAART failure history
Exclusion Criteria:
- Weight > 45 kg
- No CD4+ cell count criteria
- No significant laboratory or clinical abnormalities
- Creatinine Clearance > 60 mL/min
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
TDF+EFV
|
|
Experimental: 2
TDF+3TC+EFV
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evaluation of the efficacy of TDF+3TC+EFV versus TDF+EFV QD to maintain plasma HIV-1 RNA BLQ (< 50 copies/mL) (c/mL) at 48 weeks (W48)
Time Frame: 48 wks
|
48 wks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Comparison of the two arms for genotypic resistance profile in case of virological failure
Time Frame: 48 wks
|
48 wks
|
CD4 changes from baseline
Time Frame: 48 wks
|
48 wks
|
Evolution of the lipid profile and morphological changes in fat distribution, and safety
Time Frame: 48 wks
|
48 wks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Aldo Trylesinski, MD, Gilead Sciences
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GS-FR-104-1016
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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