NCT02247687

Management of Participants With Low-level Persistent Viremia (ANRS 161 L-VIR)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: ANRS, Emerging Infectious Diseases · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Management of participants with low-level persistent viremia

Detailed description

ANRS 161 L-Vir is a phase III prospective, randomized, multicenter, open-label, superiority trial for participants with low-level persistent viremia. Participants will be randomized with a 1:1:1 ratio to the following three arms, * Reference arm : counseling without antiretroviral treatment modification * Switch arm : switch of current PI/r for Prezista® (darunavir)/ Norvir® (ritonavir) (switch for a drug with a higher genetic barrier) 600/100 mg two times a day (BID) with counseling. * Addition of Isentress® (raltégravir) arm : Isentress® (raltegravir) 400 mg two times a day (BID) added to current antiretroviral treatment with counseling

Conditions

• HIV-1 Infection
• Treatment Resistant Disorders
• Viremia

Interventions

Type	Name	Description
DRUG	Protease inhibitor	Modification in the antiretroviral treatment •Switch arm for protease inhibitor : intervention switch of current boosted protease inhibitor for Prezista® (darunavir)/ Norvir® (ritonavir) (switch for a drug with a higher genetic barrier) 600/100 mg two times a day (BID) with counseling.
DRUG	Isentress® (raltegravir)	• Addition of Isentress® (raltegravir) arm :Isentress® (raltegravir) 400 mg two times a day (BID) added to current antiretroviral treatment with counseling
OTHER	Counseling arm	No change of antiretroviral treatment but only counseling

Timeline

• Start date: 2014-12-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2014-09-25
• Last updated: 2015-10-12

Locations

20 sites across 1 country: France