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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

March 20, 2008
June 27, 2008
March 2003
June 2005   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00643968 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Tenofovir DF + Efavirenz (TDF+EFV) Versus Tenofovir DF + Efavirenz + Lamivudine (TDF+EFV+3TC) Maintenance Regimen in Virologically Controlled Patients: COOL Trial
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

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
HIV Infections
  • Drug: EFV+TDF
  • Drug: EFV+3TC+TDF
  • Active Comparator: 1
    TDF+EFV
    Intervention: Drug: EFV+TDF
  • Experimental: 2
    TDF+3TC+EFV
    Intervention: Drug: EFV+3TC+TDF
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
140
September 2005
June 2005   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00643968
GS-FR-104-1016
Yes
Dr Aldo Trylesinski- Gilead Sciences, Gilead Sciences, Inc.
Gilead Sciences
Not Provided
Principal Investigator: Aldo Trylesinski, MD Gilead Sciences
Gilead Sciences
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP