AIDS 347: IL-6 Blockade in Treated HIV Infection

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

August 31, 2014

Primary Completion Date

September 11, 2017

Study Completion Date

September 11, 2017

Conditions
HIV Infections
Interventions
DRUG

tocilizumab

"Subjects will be randomized 1:1 to one of the following arms:~ARM A: TCZ, 4 mg/Kg by IV infusion over 60 minutes (not to exceed 400 mg) once at study entry, followed by TCZ, 8 mg/Kg by IV infusion over 60 minutes (not to exceed 800 mg) at weeks 4 and 8, and THEN placebo by IV infusion at weeks 20, 24, and 28.~ARM B: Placebo by IV infusion at study entry followed by placebo by IV infusion at weeks 4 and 8, and THEN TCZ, 4 mg/Kg (not to exceed 400 mg) by IV infusion over 60 minutes once at week 20, followed by TCZ, 8 mg/Kg (not to exceed 800 mg) by IV infusion over 60 minutes at weeks 24 and 28."

DRUG

Placebo

"Subjects will be randomized 1:1 to one of the following arms:~ARM A: TCZ, 4 mg/Kg by IV infusion over 60 minutes (not to exceed 400 mg) once at study entry, followed by TCZ, 8 mg/Kg by IV infusion over 60 minutes (not to exceed 800 mg) at weeks 4 aned 8, and THEN placebo by IV infusion at weeks 20, 24, and 28.~ARM B: Placebo by IV infusion at study entry followed by placebo by IV infusion at weeks 4 and 8, and THEN TCZ, 4 mg/Kg (not to exceed 400 mg) by IV infusion over 60 minutes once at week 20, followed by TCZ, 8 mg/Kg (not to exceed 800 mg) by IV infusion over 60 minutes at weeks 24 and 28."

Trial Locations (1)

44106

Case Clinical Research Site, Cleveland

All Listed Sponsors
lead

Case Western Reserve University

OTHER

NCT02049437 - AIDS 347: IL-6 Blockade in Treated HIV Infection | Biotech Hunter | Biotech Hunter