A Phase 3 interventional study of acyclovir sodium in Herpes Simplex, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2018-07-06.
Sponsored by Wake Forest University Health Sciences · Phase 3, Interventional, and Supportive care
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.
OBJECTIVES:
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
305 studies on the registry are indexed under Herpes Simplex; 31 are open to participants now.
This study's enrollment of 112 is above the median of 101 across 227 interventional studies indexed under Herpes Simplex.
Browse Herpes Simplex studies →Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.
Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients receive weight-based IV acyclovir sodium every 8 or 12 hours.
Drug: acyclovir sodium
Patients receive low-dose IV acyclovir sodium every 8 or 12 hours.
Drug: acyclovir sodium
Given IV
Number of Participants Experiencing Incidence of Nephrotoxicity, Defined as a Serum Creatinine ≥ 2 Times the Patient's Baseline
Time frame: 24 hours
| Milestone | Weight-based IV Acyclovir | Low-dose IV Acyclovir |
|---|---|---|
| Started | 57 | 55 |
| Completed | 56 | 55 |
| Not completed | 1 | 0 |
| Withdrew: Patient never recieved drug | 1 | 0 |
| participants | Arm I | Arm II |
|---|---|---|
| Number of Participants Experiencing Incidence of Nephrotoxicity, Defined as a Serum Creatinine ≥ 2 Times the Patient's Baseline | 2 | 3 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm I | — | 0/56 (0%) | 2/56 (3.6%) |
| Arm II | — | 0/55 (0%) | 3/55 (5.5%) |
| Event | Arm I | Arm II |
|---|---|---|
| NephrotoxicityRenal and urinary disorders | 2/56 | 3/55 |
| Age, Categorical(Participants) | Arm I | Arm II | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 42 | 39 | 81 |
| >=65 years | 15 | 16 | 31 |
| Age, Continuous(years) | Arm I | Arm II | Total |
|---|---|---|---|
| Mean | 55.3 ± 13.5 | 53.3 ± 14.4 | 54.4 ± 14.0 |
| Sex: Female, Male(Participants) | Arm I | Arm II | Total |
|---|---|---|---|
| Female | 24 | 27 | 51 |
| Male | 33 | 28 | 61 |
| Region of Enrollment(participants) | Arm I | Arm II | Total |
|---|---|---|---|
| United States | 57 | 55 | 112 |
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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Wake Forest University Health Sciences