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A Phase 1b/2 Open-Label, Dose Escalation and Expansion Study of Orally Administered VRx-3996 and Valganciclovir in Subjects with Epstein-Barr Virus-Associated Lymphoid Malignancies
Primary Objective
Determine the safety and tolerability of VRx-3996/valganciclovir. Evaluate the impact of parameters of HIV infection (e.g., CD4 cell counts, HIVqPCR) on safety and efficacy. And Evaluate the impact of VRx-3996/valganciclovir on replication of non-Alpha herpesviruses.
Details
Age
Adult
Phase
I/II - A combination of phases: (1) Research Studies that focus on the safety of a drug. The goal is to determine the drug's most frequent and serious adverse events and, often, how the drug is broken down and excreted by the body. These studies usually involve a small number of participants; and (2) Research Studies that gather preliminary data on whether a drug works in people who have a certain condition/disease (that is, the drug's effectiveness). For example, participants receiving the drug may be compared to similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied.
Type of Study
Treatment
Locations
Lone Tree Medical Center
University of Colorado Hospital
Principal Investigator
Brad Haverkos, MD
Study ID
Protocol Number: 17-2074
More information available at ClinicalTrials.gov: NCT03397706
Categories
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