Efficacy of Simplification to Atazanavir/Ritonavir + Lamivudine as Maintenance Therapy in Patients With Viral Suppression. Randomized, Open-label 96 Weeks Non-inferiority Trial (SALT)

NCT01307488 Phase 4 COMPLETED

A switch to a regimen consisting of ATV/RTV 300/100 mg QD + 3TC 300 mg QD in HIV-1 infected subjects in their first antiretroviral regimen and who are virologically suppressed on a regimen which consists of 2 NRTIs + any 3rd agent, is non-inferior to continue or switch to ATV/RTV 300/100 mg QD + 2 optimized NRTIs for maintenance of virological suppression.

Details

Lead sponsor	Fundacion SEIMC-GESIDA
Phase	Phase 4
Status	COMPLETED
Enrolment	286
Start date	2011-09
Completion	2015-03

Conditions

• HIV Infection

Interventions

• Ritonavir boosted Atazanavir + Lamivudine
• Ritonavir boosted Atazanavir + 2 NRTIs

Primary outcomes

• To assess the non-inferiority of maintenance therapy with ATV/RTV + 3TC vs ATV/RTV + 2 optimized NRTIs — Week 48
  Non-inferiority will be considered when the difference in proportion of efficacy between experimental arm (ATV/RTV + 3TC) vs. control arm (ATV/RTV + 2 optimized NRTIs) arm is less or equal to -0.12% after 48 weeks of treatment

Countries

Spain