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

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

COOL Trial

This study has been completed.

First Received: March 20, 2008 Last Updated: June 27, 2008 History of Changes

Sponsored by:	Gilead Sciences
Information provided by:	Gilead Sciences
ClinicalTrials.gov Identifier:	NCT00643968

Purpose

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

Condition	Intervention	Phase
HIV Infections	Drug: EFV+TDF Drug: EFV+3TC+TDF	Phase IV

MedlinePlus related topics: AIDS

Drug Information available for: Lamivudine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Comparison of the two arms for genotypic resistance profile in case of virological failure [ Time Frame: 48 wks ] [ Designated as safety issue: No ]
CD4 changes from baseline [ Time Frame: 48 wks ] [ Designated as safety issue: No ]
Evolution of the lipid profile and morphological changes in fat distribution, and safety [ Time Frame: 48 wks ] [ Designated as safety issue: Yes ]

Enrollment:	140
Study Start Date:	March 2003
Study Completion Date:	September 2005
Primary Completion Date:	June 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator TDF+EFV	Drug: EFV+TDF
2: Experimental TDF+3TC+EFV	Drug: EFV+3TC+TDF

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00643968

Locations

France
France and French West Indies
Paris, France

Sponsors and Collaborators

Gilead Sciences

Investigators

Principal Investigator:

Aldo Trylesinski, MD

Gilead Sciences

More Information

Additional Information:

Study Results This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Gilead Sciences, Inc. ( Dr Aldo Trylesinski- Gilead Sciences )
Study ID Numbers:	GS-FR-104-1016
Study First Received:	March 20, 2008
Last Updated:	June 27, 2008
ClinicalTrials.gov Identifier:	NCT00643968 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Gilead Sciences:

HIV virological control
Lipid profile and morphological fat distribution
Treatment Experienced

Study placed in the following topic categories:

Virus Diseases
Efavirenz
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome

Tenofovir
Lamivudine
Retroviridae Infections
Immunologic Deficiency Syndromes
Tenofovir disoproxil

Additional relevant MeSH terms:

Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on May 07, 2009