This study will test brentuximab vedotin to see if it is safe for people with human immunodeficiency virus (HIV) who have low CD4+ and have received antiretroviral therapy (ART) treatment. It will also see if brentuximab vedotin raises CD4+ counts. It will study the side effects of this drug as well. A side effect is anything a drug does to the body besides treating the disease. In this study participants will be assigned randomly to a group. Participants will get either brentuximab vedotin or placebo. A placebo looks like the drug but does not contain any medicine in it. All participants will keep getting ART during the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
University of California at San Francisco
San Francisco, California, United States
University of Illinois at Chicago
Chicago, Illinois, United States
Number of participants with adverse events (AEs)
Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment
Time frame: Through 30 days after last study treatment
Number of participants with laboratory abnormalities
Time frame: Approximately 1 year
Number of participants with dose-limiting toxicities (DLTs) by dose level
Time frame: Up to 30 days
Area under the concentration-time curve (AUC)
Pharmacokinetic (PK) Parameter
Time frame: Approximately 4 months
Maximum concentration (Cmax)
PK Parameter
Time frame: Approximately 4 months
Time to maximum concentration (Tmax)
PK Parameter
Time frame: Approximately 4 months
Apparent terminal half-life (t1/2)
PK Parameter
Time frame: Approximately 4 months
Trough concentration (Ctrough)
PK Parameter
Time frame: Approximately 4 months
Incidence of antidrug antibodies (ADAs)
Time frame: Approximately 4 months
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Proportion of participants with CD4+ T-cell lymphocyte count >200 cells/µL
Time frame: Approximately 1 year
Proportion of participants with CD4+ T-cell lymphocyte count >200 cells/µL, with a minimum increase of 50 cells/µL
Time frame: Approximately 1 year
Duration of CD4+ T-cell lymphocyte count increases >200 cells/µL
The time from start of the first occurrence of CD4+ T-cell count increases to the level \>200 cells/µL to the first occurrence of CD4+ T-cell count to the level \<200 cells/µL
Time frame: Approximately 1 year
Duration of CD4+ T-cell lymphocyte count increases >200 cells/µL with a minimum increase of 50 cells/µL
The time from start of the first occurrence of CD4+ T-cell count increases to the level \>200 cells/µL to the first occurrence of CD4+ T-cell count to the level \<200 cells/µL with a minimum increase of 50 cells/µL
Time frame: Approximately 1 year
Change from baseline in CD4+ T-cell lymphocyte counts
The change from baseline in CD4+ T-cell lymphocyte counts will be summarized based on observed values.
Time frame: Approximately 1 year
Change from baseline in CD4+ T cell percentage
The change from baseline in CD4+ T cell percentage will be summarized based on observed values.
Time frame: Approximately 1 year
Change from baseline in CD8+ T-cell lymphocyte counts
The change from baseline CD8+ T-cell lymphocyte counts will be summarized based on observed values.
Time frame: Approximately 1 year
Change from baseline in CD4:CD8 ratio
The change from baseline in CD4:CD8 ratio will be summarized.
Time frame: Approximately 1 year
Change from baseline in Treg and other T-cell subsets
Time frame: Approximately 6 months
Proportion of subjects with HIV viral load <50 copies/mL
The proportion of subjects with HIV viral load \<50 copies/mL will be summarized.
Time frame: Approximately 1 year
Proportion of subjects with fatal or non-fatal acquired immunodeficiency syndrome (AIDS) related opportunistic disease or death from any cause
Time frame: Approximately 1 year