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| Descriptive Information Fields | |||||
| Brief Title † | Phase III Randomized, Placebo-Controlled Study of Acyclovir Oral Suspension for Neonatal Herpes Simplex Virus Infection Limited to the Skin, Eyes, and Mouth | ||||
| Official Title † | |||||
| Brief Summary | OBJECTIVES: I. Determine whether acyclovir (ACV) oral suspension suppresses recurrent skin lesions and improves neurologic outcome in neonates with localized herpes simplex virus type 2 infection when administered for 6 months in a placebo-controlled study. II. Determine whether the prevention of recurrent skin lesions reduces long-term neurologic morbidity. III. Determine whether resistant disease develops after oral ACV therapy. IV. Evaluate the natural history of recurrent skin lesions. V. Measure any adverse effects and laboratory abnormalities associated with long-term oral ACV therapy in infants and young children. |
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| Detailed Description | PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by participating institution. All patients are treated with intravenous acyclovir for 14 days. Patients are then randomly assigned to 1 of 2 treatment groups if the following criteria are met: no systemic disease involvement, documented by negative cerebrospinal fluid exam, brain computerized tomography, and magnetic resonance imaging; and entry criteria continue to be met. Randomized treatment begins 8 hours after the final dose of intravenous acyclovir. One group is treated with oral acyclovir, while the control group receives an oral placebo. Treatment continues for 6 months in the absence of unacceptable toxicity, systemic disease, and 2 or more recurrences of skin lesions. Patients are followed at 6 months, then yearly for at least 4 years. The study duration is estimated to be 4 years. |
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| Study Phase | Phase III | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study | ||||
| Primary Outcome Measure † | |||||
| Secondary Outcome Measure † | |||||
| Condition † | Herpes Simplex | ||||
| Intervention † | Drug: acyclovir | ||||
| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | |||||
| Start Date † | August 1992 | ||||
| Completion Date | |||||
| Eligibility Criteria † | PROTOCOL ENTRY CRITERIA: --Disease Characteristics--
--Patient Characteristics--
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| Gender | Both | ||||
| Ages | up to 29 Days | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | |||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00004757 | ||||
| Organization ID | 199/11687 | ||||
| Secondary IDs †† | NIAID-558609 | ||||
| Study Sponsor † | National Center for Research Resources (NCRR) | ||||
| Collaborators †† | National Institute of Allergy and Infectious Diseases (NIAID) | ||||
| Investigators † |
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| Information Provided By | Office of Rare Diseases (ORD) | ||||
| Verification Date | January 1998 | ||||
| First Received Date † | February 24, 2000 | ||||
| Last Updated Date | June 23, 2005 | ||||