ObesityNCT02879630
Prospective Evaluation of Adjusted Body Weight Dosing of Acyclovir in Obesity
An observational study of Obesity, run by West Virginia University at 1 site in United States.
Trial summary
Patients receiving acyclovir as standard of care will be enrolled into this study. The currently recommended dosing strategy at our institution for obese patients is to receive intravenous acyclovir dosed per an adjusted body weight [IBW + 0.4(TBW-IBW)]. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- Type of treatment
- Injection or infusion
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Nov 2016to 16 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Obese and non-obese patients receiving intravenous acyclovir
Who may be able to join
- Age ≥18 years of age
- Receiving intravenous acyclovir 5 mg/kg (TBW for normal weight patients and ABW40 for obese patients) as part of their routine care
- Weight > 190% of ideal body weight (IBW) for "obese" patients or weight 80-120% of IBW for matched control patients.
Who cannot join
- Receipt of acyclovir or a pro-drug of acyclovir (valacyclovir, ganciclovir, valganciclovir, famciclovir) in the prior 24 hours
- Serum creatinine >1.5 mg/dL
- 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
- Significant anatomical deformities that influence body habitus (i.e. amputation)
- Prior inclusion in this study
Trial locations and contacts
1 site in 1 country.
United States1 site
West Virginia University Hospitals
Morgantown, West Virginia, 26506
About this study
Patients receiving acyclovir as standard of care will be enrolled into this study. The currently recommended dosing strategy at our institution for obese patients is to receive intravenous acyclovir dosed per an adjusted body weight [IBW + 0.4(TBW-IBW)]. They will have blood drawn once prior to the first dose of acyclovir and 10 times thereafter, over a total time period of 12 hours. These patients will already be hospitalized for other reasons, and will not be required to make additional trips to the hospital. A total of approximately 4-5 tablespoons of blood will be drawn for this study. Ten obese patients and 10 matched control (non-obese) patients will be enrolled.
- Conditions
- Obesity
- Keywords
- pharmacokinetics, acyclovir
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Obese Patients | Obese patients (patients whose weight is >190% of ideal body weight) will be receive a single dose of I.V. acyclovir sodium 5mg/kg dosed by adjusted body weight as part of their routine care. | |
| Non-obese Patients | Normal weigh patients (patients whose weight is 80-120% of ideal body weight) will be receive a single dose of I.V. acyclovir sodium 5mg/kg dosed by total body weight as part of their routine care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve (AUC) of systemic acyclovir exposure in obese and non-obese patients
Measured: 12 hours
Secondary outcomes (6)
Half-life of acyclovir in obese and non-obese patients
Measured: 12 hours
Maximum concentration (Cmax) of acyclovir in obese and non-obese patients
Measured: 12 hours
Time to maximum concentration (Tmax) of acyclovir in obese and non-obese patients
Measured: 12 hours
Volume of distribution (Vd) of acyclovir in obese and non-obese patients
Measured: 12 hours
Systemic Clearance of acyclovir in obese and non-obese patients
Measured: 12 hours
Time that concentration is above IC50 for varicella and herpes viruses in obese and non-obese patients
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2016 (estimated)
- Study start28 Nov 2016
- Primary completion16 Feb 2026
- Study completion16 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by West Virginia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aaron Cumpston, PharmD, BCOP, West Virginia University
- Investigators
- Aaron Cumpston, PharmD, BCOP, Principal investigator, West Virginia University Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02879630
- Sponsor's protocol ID
- 1501531856
- Status last verified
- Apr 2026
- First submitted
- 18 Aug 2016
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Adjusted Body Weight Dosing of Acyclovir in Obesity
- ClinicalTrials.gov ID
- NCT02879630
- Acronym / sponsor ID
- 1501531856
- Conditions
- Obesity
- Keywords
- pharmacokinetics, acyclovir
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- 28 Nov 2016 (actual)
- Primary completion
- 16 Feb 2026 (actual)
- Study completion
- 16 Feb 2026 (actual)
- First posted
- 25 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients receiving acyclovir as standard of care will be enrolled into this study. The currently recommended dosing strategy at our institution for obese patients is to receive intravenous acyclovir dosed per an adjusted body weight [IBW + 0.4(TBW-IBW)]. They will have blood drawn once prior to the first dose of acyclovir and 10 times thereafter, over a total time period of 12 hours. These patients will already be hospitalized for other reasons, and will not be required to make additional trips to the hospital. A total of approximately 4-5 tablespoons of blood will be drawn for this study. Ten obese patients and 10 matched control (non-obese) patients will be enrolled.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obese Patients | – | –Obese patients (patients whose weight is >190% of ideal body weight) will be receive a single dose of I.V. acyclovir sodium 5mg/kg dosed by adjusted body weight as part of their routine care. |
| Non-obese Patients | – | –Normal weigh patients (patients whose weight is 80-120% of ideal body weight) will be receive a single dose of I.V. acyclovir sodium 5mg/kg dosed by total body weight as part of their routine care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Obese and non-obese patients receiving intravenous acyclovir
Key inclusion criteria (3 listed)
- Age ≥18 years of age
- Receiving intravenous acyclovir 5 mg/kg (TBW for normal weight patients and ABW40 for obese patients) as part of their routine care
- Weight > 190% of ideal body weight (IBW) for "obese" patients or weight 80-120% of IBW for matched control patients.
Key exclusion criteria (7 listed)
- Receipt of acyclovir or a pro-drug of acyclovir (valacyclovir, ganciclovir, valganciclovir, famciclovir) in the prior 24 hours
- Serum creatinine >1.5 mg/dL
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Area under the curve (AUC) of systemic acyclovir exposure in obese and non-obese patients
Time frame: 12 hours
6 secondary outcomes
Half-life of acyclovir in obese and non-obese patients
Time frame: 12 hours
Maximum concentration (Cmax) of acyclovir in obese and non-obese patients
Time frame: 12 hours
Time to maximum concentration (Tmax) of acyclovir in obese and non-obese patients
Time frame: 12 hours
Volume of distribution (Vd) of acyclovir in obese and non-obese patients
Time frame: 12 hours
Systemic Clearance of acyclovir in obese and non-obese patients
Time frame: 12 hours
Time that concentration is above IC50 for varicella and herpes viruses in obese and non-obese patients
Time frame: 12 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aaron Cumpston, PharmD, BCOP principal investigator
West Virginia University Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by West Virginia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the curve (AUC) of systemic acyclovir exposure in obese and non-obese patients (time frame: 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.