Clinical trial · Observational
Effect of Body Mass on Acyclovir Pharmacokinetics
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Studies have shown that different percentages of body fat can alter the way drugs are distributed in the body. This study will use blood samples taken at different time points for patients taking acyclovir to determine if higher body weights affect drug exposure. The information gathered from this study will help understand if patients with higher body weights need a different dosing plan. Patients receiving acyclovir as standard of care will be enrolled into this study. They will have blood draws once before they take acyclovir and 10 times after they take the acyclovir (over a total of 12 hours). These patients will be in the hospital already and will not need to make additional trips back to have blood drawn. A total of about 4-5 tablespoons of blood will be drawn for this study. 7 obese patients and 7 matched, non-obese patients will be enrolled into this study.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematological Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| Pharmacokinetics of Acyclovir | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Obese Patients
- label
- Non-obese Patients
Primary outcomes (1)
- measure
- Systemic clearance of acyclovir in obese and non-obese patients
- timeFrame
- 12 hours after acyclovir dose
Secondary outcomes (5)
- measure
- Alpha and beta half-life of acyclovir in obese and non-obese patients
- timeFrame
- 12 hours after acyclovir dose
- measure
- Maximum concentration (Cmax) of acyclovir in obese and non-obese patients
- timeFrame
- 12 hours after acyclovir dose
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥18 years of age * Receiving intravenous acyclovir 5 mg/kg (total body weight \[TBW\] for normal weight patients and ideal body weight \[IBW\] for obese patients) as part of their routine care * Admitted as an inpatient with an expected stay of at least 24 hours * Weight \> 190% of ideal body weight (IBW) for "obese" patients or weight 80-120% of IBW for matched control patients. Exclusion Criteria: * Receipt of acyclovir or similar agents (valacyclovir, ganciclovir, valganciclovir, famciclovir) in the prior 24 hours * Serum creatinine \> 1.5 mg/dL at time of drug administration * Hypersensitivity to acyclovir * Patients requiring ventilator support or vasopressors in the prior 24 hours * Receipt of probenecid, mycophenolate, tenofovir, or zidovudine in the prior 7 days * Pregnant or breast-feeding * Significant anatomical deformities that influence body habitus (i.e. amputation) * Prior inclusion in this study
References
Publications (1)
- DERIVEDTurner RB, Cumpston A, Sweet M, Briggs F, Slain D, Wen S, Craig M, Hamadani M, Petros W. Prospective, Controlled Study of Acyclovir Pharmacokinetics in Obese Patients. Antimicrob Agents Chemother. 2016 Jan 11;60(3):1830-3. doi: 10.1128/AAC.02010-15. PMID 26824940