Advertisement

Topics

Phase III Randomized Study of Oral Acyclovir in Infants With Herpes Simplex Virus Infection Involving the Central Nervous System

2014-08-27 03:57:30 | BioPortfolio

Summary

OBJECTIVES: I. Determine the efficacy of long term suppressive therapy with oral acyclovir in infants with herpes simplex virus infection involving the central nervous system.

II. Determine whether neurologic outcome is improved in these patients when treated with this regimen.

III. Determine whether continuous administration of this drug suppresses recurrent skin lesions in these patients.

IV. Determine the safety of this regimen in these patients.

Description

PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients are stratified according to disease (CNS disease with or without cutaneous involvement vs disseminated disease with CNS involvement).

All patients receive acyclovir IV every 8 hours on days 1-21. On day 19, patients undergo a lumbar puncture and must have a negative CSF PCR to be randomized. If patients have a positive CSF PCR on day 19, they continue to receive acyclovir IV every 8 hours. Treatment continues every 7 days with a repeat CSF PCR on the fifth day until a negative CSF PCR result is achieved. Patients are then randomized to one of two treatment arms.

Arm I: Patients receive oral acyclovir three times a day for 6 months. Arm II: Patients receive placebo. In case of cutaneous recurrence during the first 12 months of the study, patients receive open label oral acyclovir (if CSF PCR is negative) or acyclovir IV (if CSF PCR is positive) for 5 days. Patients may or may not continue on study drug following this treatment.

Patients are followed at 6, 12, 24, 36, 48, and 60 months of age.

Study Design

Primary Purpose: Treatment

Conditions

Herpes Simplex

Intervention

acyclovir

Location

Children's Hospital of Alabama
Birmingham
Alabama
United States
35233

Status

Recruiting

Source

National Center for Research Resources (NCRR)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:57:30-0400

Clinical Trials [231 Associated Clinical Trials listed on BioPortfolio]

Acyclovir in Preventing Herpes Simplex Virus Infection in Patients With Neutropenia

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 a...

SP-303T Applied to the Skin of Patients With Herpes Simplex Virus (HSV) Infection and AIDS Who Have Not Had Success With Acyclovir

To evaluate the safety and tolerance of topically applied SP-303T in AIDS patients. To observe the effect of this drug on herpes simplex virus lesions in patients who have failed to heal i...

Study of ME-609 and Acyclovir for Treatment of Herpes Simplex Labialis in Immunocompromised Patients

The purpose of this study is to evaluate the episode duration of a herpes labialis recurrence in immunocompromised patients treated with ME-609 or Acyclovir.

Treatment of Acyclovir-Resistant Mucocutaneous Herpes Simplex Disease in Patients With AIDS: Open Label Pilot Study of Topical Trifluridine

To determine the safety, effectiveness, and toxicity of topical (local) trifluridine in treating mucocutaneous (at the nasal, oral, vaginal, and anal openings) Herpes simplex virus ( HSV )...

Acyclovir Herpes Simplex Virus (HSV) Skin, Eye, and Mouth

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 (...

PubMed Articles [261 Associated PubMed Articles listed on BioPortfolio]

Bilateral herpes simplex keratitis: lactation a trigger for recurrence!

A young lactating woman presenting to us with simultaneous bilateral corneal lesions was clinically diagnosed to have herpes simplex keratitis, which was confirmed by herpes simplex virus (HSV) PCR. T...

Hypertrophic Herpes Simplex With Subsequent Development of Plasma Cell Vulvitis: A Potential Diagnostic Pitfall.

A 37-yr-old patient previously diagnosed with human immunodeficiency virus initially presented with a genital lesion which upon histologic assessment was diagnosed as a pseudotumor associated with her...

A preclinical model for studying herpes simplex virus infection.

Herpes simplex virus (HSV) infections can cause considerable morbidity. Currently, nucleoside analogues such as acyclovir are widely used for treatment. However, HSV infections resistant to these drug...

Herpes Simplex Infection During Pregnancy, Results of a Tertiary Referral Center in Turkey.

The present study aimed to determine herpes simplex virus (HSV) infection during pregnancy, serologic status of symptomatic patients, and the frequency of PCR and culture positivity and neonatal disea...

Approach to recurrent Herpes Simplex Encephalitis in children.

Herpes Simplex Encephalitis (HSE) is one of the commonest viral encephalitis and its recurrence is being increasingly reported were HSE relapse rate came up to 5%. Both herpes simplex virus (HSV) type...

Medical and Biotech [MESH] Definitions

Trans-acting protein that combines with host factors to induce immediate early gene transcription in herpes simplex virus.

A cellular transcriptional coactivator that was originally identified by its requirement for the stable assembly IMMEDIATE-EARLY PROTEINS of the HERPES SIMPLEX VIRUS. It is a nuclear protein that is a transcriptional coactivator for a number of transcription factors including VP16 PROTEIN; GA-BINDING PROTEIN; EARLY GROWTH RESPONSE PROTEIN 2; and E2F4 TRANSCRIPTION FACTOR. It also interacts with and stabilizes HERPES SIMPLEX VIRUS PROTEIN VMW65 and helps regulate GENETIC TRANSCRIPTION of IMMEDIATE-EARLY GENES in HERPES SIMPLEX VIRUS.

A group of acute infections caused by herpes simplex virus type 1 or type 2 that is characterized by the development of one or more small fluid-filled vesicles with a raised erythematous base on the skin or mucous membrane. It occurs as a primary infection or recurs due to a reactivation of a latent infection. (Dorland, 27th ed.)

Infection of the genitals (GENITALIA) with HERPES SIMPLEX VIRUS in either the males or the females.

A GUANOSINE analog that acts as an antimetabolite. Viruses are especially susceptible. Used especially against herpes.

More From BioPortfolio on "Phase III Randomized Study of Oral Acyclovir in Infants With Herpes Simplex Virus Infection Involving the Central Nervous System"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Infectious-diseases
Antiretroviral Therapy Clostridium Difficile Ebola HIV & AIDS Infectious Diseases Influenza Malaria Measles Sepsis Swine Flu Tropical Medicine Tuberculosis Infectious diseases are caused by pathogenic...

Drug Discovery
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...


Searches Linking to this Trial