Evaluation of a Maintenance Strategy With Protease Inhibitors With or Without Lamivudine in Virologically Suppressed HIV Patients on Second Line Antiretroviral Treatment in Africa

PHASE3CompletedINTERVENTIONAL
Enrollment

265

Participants

Timeline

Start Date

February 28, 2014

Primary Completion Date

April 30, 2016

Study Completion Date

February 28, 2017

Conditions
HIV Infection
Interventions
DRUG

monoPI - boosted lopinavir or boosted darunavir

boosted lopinavir (LPV/rtv 200/50 mg 2 tbs BID) or boosted darunavir (DRV 400 mg 2 tbs plus RTV 100 mg QD) This arm was stopped by the Scientific Committee on advise of the DSMB after interim analysis showing increased risk of failure for these participants. Participants are switched to standard second line triple therapy and will be followed until the last visit at week 96.

DRUG

bi therapy - (boosted lopinavir or boosted darunavir) + lamivudine

boosted lopinavir (LPV/rtv 200/50 mg 2 tbs BID) with lamivudine 300 mg QD or boosted darunavir (DRV 400 mg 2 tbs plus RTV 100 mg QD)with lamivudine 300 mg QD. This arm is going on, patients will be followed on this intervention until the end of the study at week 96

Trial Locations (5)

Unknown

Day Care Center CHU Sanou Sauro, Bobo-Dioulasso

Central Hospital, Yaoundé

Military Hospital, Yaoundé

CRCF Hopital de Fann, Dakar

CTA CHU de Fann, Dakar

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Janssen Pharmaceuticals

INDUSTRY

lead

ANRS, Emerging Infectious Diseases

OTHER_GOV

NCT01905059 - Evaluation of a Maintenance Strategy With Protease Inhibitors With or Without Lamivudine in Virologically Suppressed HIV Patients on Second Line Antiretroviral Treatment in Africa | Biotech Hunter | Biotech Hunter