Acyclovir in Preventing Herpes Simplex Virus Infection in Patients With Neutropenia (NCT00855309) | Clinical Trial Compass
CompletedPhase 3
Acyclovir in Preventing Herpes Simplex Virus Infection in Patients With Neutropenia
United States112 participantsStarted 2008-11
Plain-language summary
RATIONALE: Acyclovir may be effective in preventing herpes simplex virus infection in patients with neutropenia.
PURPOSE: This randomized phase III trial is studying the side effects of acyclovir and is comparing two doses of acyclovir in preventing herpes simplex virus infection in patients with neutropenia.
Who can participate
Age range
18 Years – 120 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Be 18 years of age or older.
* Receiving treatment in inpatient oncology services at Wake Forest University Baptist Medical Center
* Receiving chemotherapy or have received chemotherapy within the past 2 weeks
* Seropositive herpes simplex virus (HSV)-1 or HSV-2 immunoglobulin antibody assay
* Creatinine clearance ≥ 50 mL/min
* Intravenous acyclovir sodium therapy is deemed necessary by the physician based upon clinical judgement (i.e., mucositis, vomiting, decreased GI absorption)
Exclusion Criteria:
* Pregnant or nursing
* Hypersensitivity to acyclovir sodium
* High tumor burden (i.e., WBC \> 50,000/mm\^3 at admission)
* Neutropenic, defined as one of the following:
* ANC \< 500/mm\^3
* ANC \< 1,000/mm\^3 with a predicted decrease to 500/mm\^3
* Active HSV infection, as evidenced by any of the following:
* Positive HSV cultures
* Oral lesions
* Receiving 5 mg/kg acyclovir sodium every 8 hours
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants Experiencing Incidence of Nephrotoxicity, Defined as a Serum Creatinine ≥ 2 Times the Patient's Baseline