Randomized Non-inferiority Study Comparing a Strategy Maintaining Current Enfuvirtide-based Antiretroviral Therapy to a Strategy Replacing Enfuvirtide by an Integrase Inhibitor (Raltegravir) in HIV-1 Infected Subjects With Plasma Hiv-1 RNA Levels Below 400 Copies Per ml.ANRS 138 EASIER

NCT00454337 Phase 3 COMPLETED

Switching from enfuvirtide to raltegravir in the treatment of HIV-infected patients who sustain viral suppression with a combination therapy including enfuvirtide (or : with an enfuvirtide-based combination therapy)

Details

Lead sponsor	French National Agency for Research on AIDS and Viral Hepatitis
Phase	Phase 3
Status	COMPLETED
Enrolment	170
Start date	2007-05
Completion	2008-09

Conditions

• HIV Infections

Interventions

• FTC/TDF + EFV or LPV/R +T20
• FTC/TDF + EFV or LPV/R

Primary outcomes

• comparison of the proportions of virologic failure, defined as two consecutive pVL above 400 cp per ml, through 24 weeks in enfuvirtide-maintained arm versus raltegravir arm — W24

Countries

France