AIDS 347: IL-6 Blockade in Treated HIV Infection
Condition: HIV Infections
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The study is a phase I/II, double-blind, placebo-controlled, randomized cross-over clinical
      trial of tocilizumab (TCZ) or placebo in HIV-infected subjects receiving antiretroviral
      therapy with suppressed viral replication and CD4+ T cell count ≥350 and ≤1,000 cells/mm3)
    

Detailed description: 
      DESIGN The study is a phase I/II, double-blind, placebo-controlled, randomized cross-over
      clinical trial of tocilizumab (TCZ) or placebo in HIV-infected subjects receiving
      antiretroviral therapy with suppressed viral replication and CD4+ T cell count ≥350 and
      ≤1,000 cells/mm3)

      DURATION 40 weeks during cross-over treatment periods total per subject.

      SAMPLE SIZE 30 subjects with complete data up to week 30. Up to 36 subjects may be enrolled
      in order to achieve an estimated final sample size of 30 participants with complete data up
      to week 30.

      POPULATION HIV-infected male and female subjects from 18 through 60 years of age receiving
      combination antiretroviral therapy (ART) without changes in the 24 weeks prior to enrollment
      (changes for reasons other than virologic failure allowed up to 8 weeks prior to enrollment),
      with a suppressed plasma HIV RNA (<200 copies/mL, one blip up to <1,000 copies/mL permitted)
      for at least 96 weeks and a CD4+ T-cell count ≥350 and ≤1,000 cells/mm3 at the time of study
      enrollment.

      REGIMEN 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 24, followed by TCZ, 8 mg/Kg (not to exceed 800 mg) by IV infusion over 60 minutes at
      weeks 24 and 28.
    

Intervention name(s): tocilizumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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.
Other intervention name(s): TCZ; Normal saline for infusion
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: HIV; Immune failure; Tocilizumab; ACTEMRA; Antiretroviral therapy; HAART