Tenofovir DF + Efavirenz (TDF+EFV) Versus Tenofovir DF + Efavirenz + Lamivudine (TDF+EFV+3TC) Maintenance Regimen in Virologically Controlled Patients: COOL Trial

Gilead Sciences

Status and phase: Completed; Phase 4

Conditions: HIV Infections

Treatments: Drug: EFV+3TC+TDF; Drug: EFV+TDF

Study type: Interventional

Funder types: Industry

Identifiers

NCT00643968

GS-FR-104-1016

Details and patient eligibility

About

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

Enrollment: 140 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

140 participants in 2 patient groups

1

Active Comparator group

Description:

TDF+EFV

Treatment:

Drug: EFV+TDF

2

Experimental group

Description:

TDF+3TC+EFV

Treatment:

Drug: EFV+3TC+TDF