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NCT00643968 Clinical Trial

Tenofovir DF + Efavirenz (TDF+EFV) Versus Tenofovir DF + Efavirenz + Lamivudine (TDF+EFV+3TC) Maintenance Regimen in Virologically Controlled Patients: COOL Trial

HIV Infections Clinical Trial

— COOL  

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00643968
Other study ID # GS-FR-104-1016
Secondary ID
Status Completed
Phase Phase 4
First received March 20, 2008
Last updated June 27, 2008
Start date March 2003
Est. completion date September 2005

Study information
Verified date June 2008
Source Gilead Sciences
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 140
Est. completion date September 2005
Est. primary completion date June 2005
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Drug:
• EFV+TDF

• EFV+3TC+TDF

Locations
Country Name City State
France France and French West Indies Paris

Sponsors (1)
Lead Sponsor Collaborator
Gilead Sciences

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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) 48 wks No
Secondary Comparison of the two arms for genotypic resistance profile in case of virological failure 48 wks No
Secondary CD4 changes from baseline 48 wks No
Secondary Evolution of the lipid profile and morphological changes in fat distribution, and safety 48 wks Yes
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