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Phase III Randomized, Placebo-Controlled Study of Acyclovir Oral Suspension for Neonatal Herpes Simplex Virus Infection Limited to the Skin, Eyes, and Mouth Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Phase III Randomized, Placebo-Controlled Study of Acyclovir Oral Suspension for Neonatal Herpes Simplex Virus Infection Limited to the Skin, Eyes, and Mouth conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Phase III Randomized, Placebo-Controlled Study of Acyclovir Oral Suspension for Neonatal Herpes Simplex Virus Infection Limited to the Skin, Eyes, and Mouth Clinical research trials and Phase III Randomized, Placebo-Controlled Study of Acyclovir Oral Suspension for Neonatal Herpes Simplex Virus Infection Limited to the Skin, Eyes, and Mouth health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Phase III Randomized, Placebo-Controlled Study of Acyclovir Oral Suspension for Neonatal Herpes Simplex Virus Infection Limited to the Skin, Eyes, and Mouth. Phase III Randomized, Placebo-Controlled Study of Acyclovir Oral Suspension for Neonatal Herpes Simplex Virus Infection Limited to the Skin, Eyes, and Mouth Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Phase III Randomized, Placebo-Controlled Study of Acyclovir Oral Suspension for Neonatal Herpes Simplex Virus Infection Limited to the Skin, Eyes, and Mouth clinical trial. Human subjects often get the best healthcare possible for their Phase III Randomized, Placebo-Controlled Study of Acyclovir Oral Suspension for Neonatal Herpes Simplex Virus Infection Limited to the Skin, Eyes, and Mouth condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Phase III Randomized, Placebo-Controlled Study of Acyclovir Oral Suspension for Neonatal Herpes Simplex Virus Infection Limited to the Skin, Eyes, and Mouth  Phase III Randomized, Placebo-Controlled Study of Acyclovir Oral Suspension for Neonatal Herpes Simplex Virus Infection Limited to the Skin, Eyes, and Mouth
Phase III Randomized, Placebo-Controlled Study of Acyclovir Oral Suspension for Neonatal Herpes Simplex Virus Infection Limited to the Skin, Eyes, and Mouth
For Condition: Herpes Simplex
Status: Completed
Sponsor(s): National Center for Research Resources (NCRR) , National Institute of Allergy and Infectious Diseases (NIAID)
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study
Minimum Age/Maximum Age: /29 Days
Genders: Both
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Virologically confirmed herpes simplex virus type 2 (HSV-2) with skin lesions localized to the skin, eyes, and mouth - No central nervous system or disseminated disease Normal cerebrospinal fluid WBC less than 20 Protein less than 90 mg/dL - Normal brain computerized tomography or magnetic resonance imaging (MRI) MRI if feasible - No HSV-1 --Patient Characteristics-- - Age: Under 29 days - Renal: Creatinine no greater than 1.5 mg/dL - Other: Birth weight at least 1200 g - Gestational age greater than 32 weeks - No breast feeding if mother on acyclovir
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RichardWhitley, Study Chair, National Institute of Allergy and Infectious Diseases (NIAID)
Additional Information:
Study ID Numbers: 199/11687; NIAID-558609
Study Start Date: August 1992
Record last reviewed: January 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004757
Other Herpes Simplex Studies:
1. Phase III Randomized Study of Oral Acyclovir in Infants With Herpes Simplex Virus Infection Limited to Skin, Eyes, and Mouth
2. The Effect of Acyclovir Treatment of the Herpes Simplex Virus (HSV) Infection on HIV Levels in the Blood
3. A Study to Compare the Efficacy and Safety of Valacyclovir Hydrochloride ( 256U87 ) Versus Acyclovir in the Treatment of Recurrent Anogenital Herpes Infections in HIV Infected Patients
4. Valaciclovir to Prevent Transmission of Herpes Simplex Virus
5. A Phase I/II Study of the Safety and Efficacy of Topical 1-(S)-(3-Hydroxy-2-phosphonylmethoxypropyl)cytosine Dihydrate (Cidofovir; HPMPC) in the Treatment of Refractory Mucocutaneous Herpes Simplex Disease in Patients With AIDS
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Phase III Randomized, Placebo-Controlled Study of Acyclovir Oral Suspension for Neonatal Herpes Simplex Virus Infection Limited to the Skin, Eyes, and Mouth
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