Herpes Simplex
Conditions
Keywords
chemotherapeutic agent toxicity, renal toxicity, infection, neutropenia
Brief 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.
Detailed description
OBJECTIVES: * To determine the difference in nephrotoxicity between low-dose and weight-based intravenous acyclovir sodium as herpes simplex virus infection prophylaxis in patients with neutropenia. OUTLINE: Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive weight-based IV acyclovir sodium every 8 or 12 hours. * Arm II: Patients receive low-dose IV acyclovir sodium every 8 or 12 hours. Treatment continues for approximately 2 weeks unless clinical herpes simplex virus infection is confirmed or the patient is no longer neutropenic.
Interventions
DRUGacyclovir sodium
Given IV
Sponsors
National Cancer Institute (NCI)
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants Experiencing Incidence of Nephrotoxicity, Defined as a Serum Creatinine ≥ 2 Times the Patient's Baseline | 24 hours |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm I Patients receive weight-based IV acyclovir sodium every 8 or 12 hours. | 57 |
| Arm II Patients receive low-dose IV acyclovir sodium every 8 or 12 hours. | 55 |
| Total | 112 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | patient never recieved drug | 1 | 0 |
Baseline characteristics
| Characteristic | Arm I | Arm II | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 15 Participants | 16 Participants | 31 Participants |
| Age, Categorical Between 18 and 65 years | 42 Participants | 39 Participants | 81 Participants |
| Age, Continuous | 55.3 years STANDARD_DEVIATION 13.5 | 53.3 years STANDARD_DEVIATION 14.4 | 54.4 years STANDARD_DEVIATION 14 |
| Region of Enrollment United States | 57 participants | 55 participants | 112 participants |
| Sex: Female, Male Female | 24 Participants | 27 Participants | 51 Participants |
| Sex: Female, Male Male | 33 Participants | 28 Participants | 61 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 56 | 3 / 55 |
| serious Total, serious adverse events | 0 / 56 | 0 / 55 |
Outcome results
Primary
Number of Participants Experiencing Incidence of Nephrotoxicity, Defined as a Serum Creatinine ≥ 2 Times the Patient's Baseline
Time frame: 24 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm I | Number of Participants Experiencing Incidence of Nephrotoxicity, Defined as a Serum Creatinine ≥ 2 Times the Patient's Baseline | 2 participants |
| Arm II | Number of Participants Experiencing Incidence of Nephrotoxicity, Defined as a Serum Creatinine ≥ 2 Times the Patient's Baseline | 3 participants |