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
|
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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 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 |
Actual Primary Completion Date : | June 2005 |
Actual Study Completion Date : | September 2005 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 1
TDF+EFV
|
Drug: EFV+TDF |
Experimental: 2
TDF+3TC+EFV
|
Drug: EFV+3TC+TDF |
- 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 ]
- Comparison of the two arms for genotypic resistance profile in case of virological failure [ Time Frame: 48 wks ]
- CD4 changes from baseline [ Time Frame: 48 wks ]
- Evolution of the lipid profile and morphological changes in fat distribution, and safety [ Time Frame: 48 wks ]

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
France | |
France and French West Indies | |
Paris, France |
Principal Investigator: | Aldo Trylesinski, MD | Gilead Sciences |
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 |