Personalized Acyclovir Dosage for Obese Patients
Individualization of Dosage Regimens in Obese Patients: Application to Acyclovir
This study is testing how body weight affects the way obese patients process acyclovir to find the best dosage for their treatment.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | University Hospital, Toulouse Academic / other |
| Locations | 1 site (Toulouse) |
| Trial ID | NCT05589688 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate how lean body mass affects the elimination of acyclovir in obese patients. It will involve healthy volunteers categorized into four groups based on their BMI: non-obese, overweight, and two grades of obesity. By measuring plasma and urine concentrations, researchers will develop a pharmacokinetic model to better understand the appropriate dosage regimens for acyclovir in these populations. The goal is to ensure effective and safe treatment for obese patients who may not respond well to standard dosages.
Who should consider this trial
Good fit: Ideal candidates include healthy volunteers aged 18 and older with a BMI between 18 and 39.9 kg/m2.
Not a fit: Patients with nephrotoxic conditions or those on medications that affect acyclovir pharmacokinetics may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and safer dosing guidelines for acyclovir in obese patients.
How similar studies have performed: While there is limited data on personalized dosing for acyclovir in obese patients, similar pharmacokinetic studies have shown promise in optimizing drug regimens for various populations.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Toulouse
- Toulouse Hospital — Toulouse, France (Recruiting)
Study contacts
- Principal investigator: Sarah Baklouti, PharmD — University Hospital, Toulouse
- Study coordinator: Sarah Baklouti, PharmD
- Email: baklouti.s@chu-toulouse.fr
- Phone: 05 67 69 03 83
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.