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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 (COOL)

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ClinicalTrials.gov Identifier: NCT00643968
Recruitment Status : Completed
First Posted : March 26, 2008
Last Update Posted : June 30, 2008
Sponsor:
Information provided by:

Study Description
Brief 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


Condition or disease Intervention/treatment Phase
HIV Infections Drug: EFV+TDF Drug: EFV+3TC+TDF Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : March 2003
Primary Completion Date : June 2005
Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Arm Intervention/treatment
Active Comparator: 1
TDF+EFV
Drug: EFV+TDF
Experimental: 2
TDF+3TC+EFV
Drug: EFV+3TC+TDF


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Comparison of the two arms for genotypic resistance profile in case of virological failure [ Time Frame: 48 wks ]
  2. CD4 changes from baseline [ Time Frame: 48 wks ]
  3. Evolution of the lipid profile and morphological changes in fat distribution, and safety [ Time Frame: 48 wks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: March 26, 2008    Key Record Dates
Last Update Posted: June 30, 2008
Last Verified: June 2008

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

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases