Acyclovir Herpes Simplex Virus (HSV) Skin, Eye, and Mouth
Public ClinicalTrials.gov record NCT00031447. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Placebo-Controlled Phase III Evaluation of Suppressive Therapy With Oral Acyclovir Suspension Following Neonatal Herpes Simplex Virus Infections Limited to the Skin, Eye, and Mouth
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to test whether long-term treatment with oral acyclovir improves the outcome for infants with herpes simplex virus (HSV) disease of the skin, eyes, and mouth (SEM). Study participants will include infants in the United States and Canada who have HSV disease of the skin, eyes, and mouth, with no central nervous system disease present. Initially, all subjects will be treated with acyclovir administered through IV access (through the vein) for 14 days while hospitalized. Participants will then be placed in one of two groups, acyclovir given by mouth or a placebo (substance with no medication present). The participant and the study site will not know to which group the subject is assigned. All children will be followed at 6, 12, 24, 36, 48, and 60 months of age. During the follow up visits, physicals, hearing assessments, eye assessments, and neurological assessments will be completed.
Study identification
- NCT ID
- NCT00031447
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 29 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- Up to 28 Days
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 1999 (Type not available)
- Primary completion
- Feb 2008 (Actual)
- Completion
- Apr 2008 (Actual)
- Last update posted
- May 16, 2012
1999 – 2008
United States locations
- U.S. sites
- 27
- U.S. states
- 21
- U.S. cities
- 27
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | — |
| Arkansas Children's Hospital, Department of Infectious Diseases | Little Rock | Arkansas | 72202 | — |
| Rady Children's Hospital San Diego | San Diego | California | 92123 | — |
| Stanford University School of Medicine | Stanford | California | 94305-5208 | — |
| University of Florida - College of Medicine - Jacksonville | Jacksonville | Florida | 32209 | — |
| The University of Chicago - Comer Children's Hospital - Infectious Diseases | Chicago | Illinois | 60637 | — |
| Kosair Children's Hospital | Louisville | Kentucky | 40202 | — |
| Tulane University - Tulane Medical Center - Department of Pediatrics | New Orleans | Louisiana | 70112 | — |
| Maine Medical Center - Department of Pediatric Specialty Care - Infectious Disease | Portland | Maine | 04101 | — |
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | — |
| Children's Hospital of Michigan - Pediatric Infectious Diseases | Detroit | Michigan | 48201 | — |
| University of Mississippi | Jackson | Mississippi | 39216-4505 | — |
| Washington University School of Medicine in St. Louis - Center for Clinical Studies | St Louis | Missouri | 63110 | — |
| Mount Sinai Hospital | New York | New York | 10029 | — |
| UNY Upstate Medical University Hospital - Pediatrics | Syracuse | New York | 13210 | — |
| Carolinas Medical Center | Charlotte | North Carolina | 28203 | — |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45231 | — |
| MetroHealth Medical Center - Pediatric Infectious Disease | Cleveland | Ohio | 44109-1998 | — |
| Nationwide Children's Hospital - Infectious Diseases | Columbus | Ohio | 43205 | — |
| Oregon Health and Science University | Portland | Oregon | 97201-3098 | — |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Vanderbilt University | Nashville | Tennessee | 37232 | — |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390-9063 | — |
| Cook Children's Infectious Disease Services | Fort Worth | Texas | 76104 | — |
| University of Texas Health Science Center San Antonio - Pediatrics - Immunology & Infectious Disease | San Antonio | Texas | 78229 | — |
| Seattle Children's Hospital - Infectious Diseases | Seattle | Washington | 98105 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00031447, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 16, 2012 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00031447 live on ClinicalTrials.gov.