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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.
Sponsor:
Information provided by:
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00643968
First received: March 20, 2008
Last updated: June 27, 2008
Last verified: June 2008
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Lamivudine
U.S. FDA Resources

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
Active Comparator: 1
TDF+EFV
 Drug: EFV+TDF
Experimental: 2
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: Dr Aldo Trylesinski- Gilead Sciences, Gilead Sciences, Inc.
ClinicalTrials.gov Identifier: NCT00643968     History of Changes
Other Study ID Numbers: GS-FR-104-1016
Study First Received: March 20, 2008
Last Updated: June 27, 2008
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Gilead Sciences:
HIV virological control
Lipid profile and morphological fat distribution
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
 Lamivudine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on May 16, 2013