CD24Fc Administration to Decrease Low-Density Lipoprotein (LDL) and Inflammation in Human Immunodeficiency Virus (HIV) Patients (CALIBER) (MK-7110-003)
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Dyslipidemias
- HIV Infections
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Randomized, double blinded, placebo controlled.Masking: Triple (Participant, Care Provider, Investigator)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 50 years and 125 years
- Gender
- Both males and females
Description
This study is a phase 2, randomized, placebo-control, double-blinded clinical trial to assess the effect of CD24Fc on reduction in low-density lipoprotein (LDL) among patients with HIV. The effect of CD24Fc on total cholesterol and triglycerides, markers of immune activation (T cell activation, sCD1...
This study is a phase 2, randomized, placebo-control, double-blinded clinical trial to assess the effect of CD24Fc on reduction in low-density lipoprotein (LDL) among patients with HIV. The effect of CD24Fc on total cholesterol and triglycerides, markers of immune activation (T cell activation, sCD14, and inflammatory cytokines), size of HIV reservoirs, hemoglobin (HbA1c) and leptin, and hepatic steatosis will be evaluated. It is hypothesized that therapy with CD24Fc will result in significant decreases in LDL in HIV patients. In addition, CD24Fc may reduce leptin and cholesterol, HbA1c, hepatic steatosis and fibrosis, and markers of inflammation in patients with chronic HIV who are virally suppressed on antiretroviral therapy (ART). In this phase 2 study, a cohort of 64 HIV patients virally suppressed on antiretroviral therapy will be randomized in a 1:1 fashion to receive an intravenous infusion of 240 mg of CD24Fc vs. placebo administered every 2 weeks during a 4-week treatment window, followed by a 24- week follow-up period. Patients will be followed for safety and adverse events as well as changes in lipid metabolism and inflammatory markers during a 24-week follow-up period. This investigation will take place at the University of Maryland.
Tracking Information
- NCT #
- NCT03960541
- Collaborators
- University of Maryland, Baltimore
- Investigators
- Study Director: Medical Director Merck Sharp & Dohme Corp.
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