Personalized Acyclovir Dosage for Obese Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Ocular Changes in People Using Tirzepatide or Semaglutide

  This study checks whether eye structure and blood vessels change in adults with obesity who are taking semaglutide or tirzepatide as part of routine care.

  Recruiting Istanbul University · Istanbul, Istanbul · NCT07924618

• Whole-Body Vibration Training in Women With Obesity With and Without Type 2 Diabetes

  This study tests whether eight weeks of supervised whole-body vibration training changes ankle muscle activity and walking performance in women with obesity, comparing those with and without type 2 diabetes.

  Recruiting Pamukkale University · Denizli · NCT07924436

• Berobenatide for knee pain in adults who are overweight or with obesity

  This study tests berobenatide vs. placebo to see if it reduces knee pain and improves function while helping with weight in adults with knee osteoarthritis and overweight/obesity.

  Recruiting at 7 sites Phase 3 Pfizer · Tempe, Arizona and 39 other locations · NCT07919678

• Weekly berobenatide for knee osteoarthritis in adults who are overweight or obese

  This study tests whether weekly berobenatide helps reduce knee pain and improve function, while also affecting body weight, in adults with knee osteoarthritis who are overweight or obese (with or without type 2 diabetes).

  Recruiting Phase 3 Pfizer · Birmingham, Alabama and 3 other locations · NCT07915609

• Maridebart cafraglutide in people who switched from weekly GLP-1 receptor agonists

  This study tests how much maridebart cafraglutide appears in the blood after people with overweight or obesity switch from weekly GLP-1 receptor agonists.

  Recruiting at 9 sites Phase 1 Amgen · Phoenix, Arizona and 8 other locations · NCT07908316

• EloraTZP for weight loss in adults with overweight/obesity and type 2 diabetes

  This trial tests whether a coformulation of eloralintide and tirzepatide helps people with obesity or overweight and type 2 diabetes lose weight compared with tirzepatide alone.

  Recruiting Phase 3 Eli Lilly and Company · Tucson, Arizona and 74 other locations · NCT07881458

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.