Actively Recruiting
Individualization of Dosage Regimens in Obese Patients: Application to Acyclovir
Led by University Hospital, Toulouse · Updated on 2025-12-31
20
Participants Needed
1
Research Sites
138 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The number of obese people will reach 50% of the world population by 2035. Obesity is a chronic disease. For obese patients, dosage regimens have been determined for patients with a "normal" BMI between 20-30 kg/m2. Based on plasma and urine concentrations, a pharmacokinetic model will be performed to study in healthy volunteers, the predictive character of lean mass, measured by DEXA, on renal elimination and therefore on acyclovir exposure. The main objective of this study is to evaluate, in 4 volunteers groups representative of (1) non-obese (18-24.9 kg/m2), (2) overweight (25-29.9 kg/m2), (3) grade 1 obesity (30-34.9 kg/m2) and (4) grade 2 obesity (35-39.9 kg/m2), the predictive nature of lean mass, measured by DEXA, on renal elimination and therefore on acyclovir exposure.
CONDITIONS
Official Title
Individualization of Dosage Regimens in Obese Patients: Application to Acyclovir
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy volunteers with a BMI between 18 and 39.9 kg/m2 divided into 4 groups: non-obese (18-24.9), overweight (25-29.9), grade 1 obesity (30-34.9), and grade 2 obesity (35-39.9)
- Volunteers with an estimated glomerular filtration rate (aGFR) greater than 50 ml/min
- Volunteers with a good venous pathway suitable for blood sampling
- Women who are using contraception or are postmenopausal
- Individuals who have given written informed consent and are affiliated with public health insurance
You will not qualify if you...
- Volunteers using nephrotoxic drugs or medications that alter acyclovir pharmacokinetics such as diuretics, NSAIDs, or statins
- History of serious allergic reactions to drugs (e.g., angioedema)
- Presence of significant organ insufficiencies like liver failure or heart failure
- Diagnosis of diabetes or current use of anti-diabetic medications
- Diagnosis of arterial hypertension or use of antihypertensive drugs
- Use of drugs that interact with acyclovir including H2 receptor antagonists, probenecid, mycophenolate mofetil, lithium, or anti-calcineurins
- Use of anticoagulant medications
- Known hypersensitivity to acyclovir
- Pregnant women
- Participation in another clinical study within the last two months
- Current viral HSV or VZV infection being treated with acyclovir
- Adults under guardianship, legal protection, or deprived of liberty by judicial or administrative decision
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Toulouse Hospital
Toulouse, France
Actively Recruiting
Research Team
S
Sarah Baklouti, PharmD
CONTACT
C
Charline DAGUZAN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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