Ebola Clinical Trial - Drug-drug Interactions Between Remdesivir &

Status Completed

Clinical Trial Summary

Ebola and HIV are found predominately in the same regions of the world and countries in sub-Saharan Africa are most affected by both diseases. For Ebola, no approved therapies exist. However, new investigational drugs are being evaluated to understand if they are effective against the Ebola virus. Remdesivir is an anti-Ebola investigational drug for the treatment of Ebola. Little is known about how the blood levels of remdesivir relate to how effective it is in patients with HIV taking antiretroviral therapy. This study will explore how commonly utilized ART (tenofovir/lamivudine and atazanavir/ritonavir) affect the drug levels of remdesivir.

Clinical Trial Description

The study is designed as an open-label, randomized, fixed sequence, single intravenous dosing study to assess the effects of antiretrovirals on remdesivir pharmacokinetics. The selection of healthy volunteers, as opposed to patients with HIV, avoids the greatest possible extent confounding factors, such as enzyme or transporter activity alteration in inflammatory states, concomitant medications potentially impacting drug disposition and other factors which are commonly present in a population of patients and cannot be easily eliminated. Objectives: Primary objective 1. To assess the safety and tolerability of single intravenous doses of remdesivir in adult healthy volunteers 2. To evaluate the intracellular pharmacokinetics of single dose intravenous remdesivir with or without co-administration of oral fixed-dose combination tenofovir/lamivudine with patients serving as their own controls Secondary objectives 1. To evaluate the difference in plasma and intracellular pharmacokinetics of intravenous remdesivir among healthy volunteers receiving tenofovir/lamivudine versus healthy volunteers receiving tenofovir/lamivudine plus atazanavir/ritonavir tablets. 2. To generate a population pharmacokinetic model to describe inter-individual variability in intracellular pharmacokinetics of remdesivir Exploratory objectives 1. To describe polymorphic variants of relevant kinases that activate TFV and explore possible consequences on remdesivir PK. ;

Study Design

Related Conditions & MeSH terms

Acquired Immunodeficiency Syndrome
Ebola
HIV Infections
HIV/AIDS

Clinical Trial Details

NCT number	NCT04385719
Study type	Interventional
Source	Makerere University
Contact
Status	Completed
Phase	Phase 2
Start date	May 5, 2021
Completion date	July 16, 2021

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Drug-drug Interactions Between Remdesivir and Commonly Used Antiretroviral Therapy — RemTLAR

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms