Phase 3 N=112 Randomized Supportive Care

Acyclovir in Preventing Herpes Simplex Virus Infection in Patients With Neutropenia

Herpes Simplex

Bottom Line

View on ClinicalTrials.gov: NCT00855309 ↗

Enrolled (actual)

112

Serious AEs

0.0%

Results posted

Nov 2013

Primary outcome: Primary: Number of Participants Experiencing Incidence of Nephrotoxicity, Defined as a Serum Creatinine ≥ 2 Times the Patient's Baseline — 2; 3 participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: acyclovir sodium (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Wake Forest University Health Sciences
Primary completion: Nov 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Experiencing Incidence of Nephrotoxicity, Defined as a Serum Creatinine ≥ 2 Times the Patient's Baseline	2; 3	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00855309). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.