NCT01307488

Simplification to Atazanavir/Ritonavir + Lamivudine as Maintenance Therapy

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 286 (actual)
• Sponsor: Fundacion SEIMC-GESIDA · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Clinical Trial, phase IV, randomized, open label, multicenter with approved drugs in their use conditions. 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.

Conditions

• HIV Infection

Interventions

Type	Name	Description
DRUG	Ritonavir boosted Atazanavir + Lamivudine	ATV/RTV 300/100 mg QD + 2 optimized NRTIs for the first 4 weeks and then they will receive ATV/RTV 300/100 mg QD (once daily) and 3TC 300 mg QD for another 92 weeks. Treatment should be taken orally with a light meal at the same time each day.
DRUG	Ritonavir boosted Atazanavir + 2 NRTIs	ATV/RTV 300/100 mg QD + 2 optimized NRTIs for 96 weeks. Treatment should be taken orally with a light meal at the same time each day.

Timeline

• Start date: 2011-09-01
• Primary completion: 2014-04-01
• Completion: 2015-03-01
• First posted: 2011-03-03
• Last updated: 2015-05-12

Locations

36 sites across 1 country: Spain