Individualization of Dosage Regimens in Obese Patients: Application to Acyclovir

Launched by UNIVERSITY HOSPITAL, TOULOUSE · Oct 17, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at how to adjust the dosage of a medication called acyclovir for people who are obese. Acyclovir is used to treat certain viral infections, and this study aims to better understand how the body processes this medication in individuals with different body weights. The researchers will compare four groups of healthy volunteers based on their body mass index (BMI): non-obese, overweight, and two categories of obesity. By measuring the amount of lean body mass using a specialized scan, they hope to find a better way to determine the right dose of acyclovir for obese patients.

To participate in this study, volunteers must be healthy adults aged between 18 and 65 with a BMI between 18 and 39.9. Participants should not have serious health issues, like kidney problems or diabetes, and must not be taking certain medications that could interfere with the study. If eligible, participants can expect to undergo some tests, including the DEXA scan, and will provide information about how their bodies process the medication. This research is important because it may lead to more personalized and effective treatments for people with obesity in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • healthy volunteers with a BMI between 18 and 39,9 kg/m2, divided into 4 groups: 5 non-obese volunteers (BMI between 18 and 24,9 kg/m2), 5 overweight volunteers (BMI between 25 and 29,9 kg/m2), 5 volunteers with grade 1 obesity (BMI between 30 and 34,9 kg/m2) and 5 volunteers with grade 2 obesity (BMI between 35 and 39,9 kg/m2),
• • volunteers with a aGFR \> 50 ml/min,
• • with a good venous pathway for kinetics,
• • women on contraception or postmenopausal women,
• • person who has given written consent and affiliated with the public health insurance.
• Exclusion Criteria:
• • volunteers with nephrotoxic co-prescriptions and/or co-prescriptions that would modify the pharmacokinetics of acyclovir like diuretics, NSAIDs or statins,
• • having presented serious allergies to a drug (e.g. angioedema...), with large parenchyma insufficiencies (e.g., hepatic insufficiency, heart failure...),
• • with diabetes or taking anti-diabetics due to the possible deterioration of renal function in diabetic patients,
• • with arterial hypertension or taking antihypertensive drugs due to the possible modification of renal clearance by modification of blood flow,
• • drug interactions with acyclovir (H2 receptor antagonists (e.g., Cimetidine), Probenecid, Mycophenolate Mofetil, Lithium, Anti-calcineurins (Ciclosporin, Tacrolimus)),
• • volunteers taking anticoagulants,
• • hypersensitivity to acyclovir,
• • pregnant woman,
• • participation in another clinical study in the last two months
• • volunteers with ongoing viral HSV/VZV infection treated with acyclovir,
• • adults under guardianship or other legal protection, deprived of their liberty by judicial or administrative decision