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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00643968

Acronym

COOL

Enrollment

140

Registered

2008-03-26

Start date

2003-03-31

Completion date

2005-09-30

Last updated

2008-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

HIV virological control, Lipid profile and morphological fat distribution, Treatment Experienced

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

Interventions

DRUGEFV+TDF

DRUGEFV+3TC+TDF

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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)	48 wks

Secondary

Measure	Time frame
Comparison of the two arms for genotypic resistance profile in case of virological failure	48 wks
CD4 changes from baseline	48 wks
Evolution of the lipid profile and morphological changes in fat distribution, and safety	48 wks

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026