NEWS HIGHLIGHTS
Published Studies Related to Vira-A (Vidarabine Topical)
Antiviral agents for treatment of herpes simplex virus infection in neonates. [2009.07.08]
CONCLUSIONS: There is insufficient trial evidence to evaluate the effects of antiviral agents with controls or with each other. The rarity of the condition makes effectively powered clinical trials difficult to perform. The efficacy of newer antiviral agents with better bioavailability (e.g. valaciclovir, valganciclovir) for the treatment of neonatal disease needs to be evaluated in randomised trials. The efficacy of oral formulations need to be evaluated as they may be useful for infants with skin, eye or mouth HSV disease or in the treatment of infants with recurrences after the neonatal period.
Disseminated herpes zoster in the immunocompromised host: a comparative trial of acyclovir and vidarabine. The NIAID Collaborative Antiviral Study Group. [1992.03]
Seventy-three immunocompromised patients with disseminated herpes zoster were evaluated in a double-blind controlled trial of acyclovir (n = 37) versus vidarabine (n = 36) therapy. Acyclovir was administered at 30 mg/kg/day at 8-h intervals and vidarabine was given as a continuous 12-h infusion at 10 mg/kg/day for 7 days (longer if resolution of cutaneous or visceral disease was incomplete)...
A controlled trial comparing foscarnet with vidarabine for acyclovir-resistant mucocutaneous herpes simplex in the acquired immunodeficiency syndrome. The AIDS Clinical Trials Group. [1991.08.22]
BACKGROUND AND METHODS... Once the treatment is stopped, however; there is a high frequency of relapse.
A controlled trial comparing vidarabine with acyclovir in neonatal herpes simplex virus infection. Infectious Diseases Collaborative Antiviral Study Group. [1991.02.14]
BACKGROUND.The study lacked statistical power to determine whether there were sizable differences within the subgroups of those with localized HSV, encephalitis, or disseminated disease.
Current therapy of varicella zoster virus infection in immunocompromised patients. A comparison of acyclovir and vidarabine. [1988.08.29]
Both acyclovir and vidarabine are effective treatment for varicella zoster virus (VZV) infection in immunosuppressed patients. To determine which is preferable, therapy with these two agents was compared in a prospective, randomized trial...
Clinical Trials Related to Vira-A (Vidarabine Topical)
Comparison of Foscarnet Versus Vidarabine in the Treatment of Herpes Infection in Patients With AIDS Who Have Not Had Success With Acyclovir [Completed]
To compare the safety and effectiveness of foscarnet and vidarabine treatments for AIDS
patients who have herpes simplex virus infections that are resistant to standard treatment
with acyclovir.
Foscarnet is a drug that inhibits viruses and has been shown to be effective against
infection with Cytomegalovirus and also against infection with the Herpes simplex virus in
several patients with AIDS. Vidarabine has been shown to have activity against the Herpes
simplex virus in patients who do not have AIDS, but it has not been studied in patients who
do have AIDS. This study compares foscarnet and vidarabine treatments for AIDS patients who
have herpes simplex infection that has not responded to therapy with acyclovir in the hope
that one of these two drugs will help to stop further progression of the herpes simplex
infection and may have fewer side effects.
Safety of and Immune Response to a West Nile Virus Vaccine (WN/DEN4-3'delta30) in Healthy Adults [Completed]
Evaluation of the Safety of a Polyvalent Virus in Healthy Adults
This is a research study to evaluate the safety of a vaccine to protect people from HIV
infection. Human Immunodeficiency Virus (HIV) is the cause of AIDS (Acquired Immune
Deficiency Syndrome). AIDS is one of the most serious viral infections of our time. It is
believed that all persons who contract HIV will eventually develop AIDS. Because of this, we
are trying to develop new ways to prevent infection with HIV.
The vaccine that will be tested in this study has been prepared from a small part of the HIV.
The part of the HIV used in this vaccine is the "envelope" or coating part of the virus. In
this study, researchers will evaluate how well the vaccine is tolerated, how much vaccine
should be given, and determine if any side effects occur in response to the vaccination.
Treating Severe Chronic Epstein-Barr Virus (EBV) Infection With EBV Specific Cytotoxic T Lymphocytes (CTLs) [Active, not recruiting]
Severe chronic active Epstein-Barr virus (SCAEBV) is a rare Epstein-Barr virus (EBV or
commonly known as mono or the kissing disease) associated disorder. This disorder may cause
chronic tiredness and fevers and sometimes be complicated by life threatening problems such
as multi-organ failure, chronic (ongoing) pneumonia, and lymphoproliferative diseases
(diseases involving the lymph nodes which could eventually show up as leukemia or a tumor).
The reasons for the body's inability to control the EBV infection are still unknown and no
effective treatment is currently available.
This research study uses Epstein-Barr virus (EBV) specific cytotoxic T lymphocytes (CTLs). We
want to see if we can grow special white blood cells, called T cells, that have been trained
to kill EBV infected cells in the laboratory and see if these cells may help control the EBV
infection when given back to the patient.
The purpose of this study is to find the largest safe dose of EBV specific CTLs, to learn
what the side effects are, and to see whether this therapy might help the body fight off the
SCAEBV infection.
Natural History of West Nile Virus Infection [Active, not recruiting]
This study will examine how West Nile virus (WNV) infection affects the body. Some people
infected with WNV have no symptoms. In others, symptoms may vary from fever and headache to
a polio-like syndrome with paralysis, to coma and brain changes like those of a stroke. Many
patients recover with no lasting effects, while a few can have long-lasting neurological
damage or may die. This study will collect clinical, laboratory, diagnostic, and
radiographic information on people thought to have WNV to better understand the disease.
Patients 18 years of age and older diagnosed with or suspected of having West Nile virus
infection may be eligible for this study. Patients will be hospitalized until they are well
enough to go home and will undergo the following tests and procedures:
- Medical history and physical examination: A thorough history and physical examination
will be done on the first day of the study. Then, brief physical exams, including
measures of blood pressure, heart rate, breathing rate, and temperature, will be done
during each day of hospitalization and at every follow-up clinic visit (at 2 weeks and
at 1, 3, and 6 months).
- Blood tests: Blood samples will be collected on the first day of the study, at day 7, at
hospital discharge, and at follow-up visits to determine if virus remains in the blood
and how it is affecting the body.
- Magnetic resonance imaging (MRI): MRI scans will be done within 72 hours of beginning
the study and 1 month after that. This test uses a strong magnetic field and radio
waves to produce images of the brain that might show abnormalities in the brains of
patients with WNV and reveal whether the abnormalities can predict how an individual
will recover. For the procedure, the patient lies on a table that is moved into the
narrow tunnel-like scanner. During the procedure, a contrast agent that brightens the
images is injected through a catheter placed in an arm vein.
- Neurological examination and neurological function tests: Participants will be tested
to see if the West Nile virus has affected their thinking and ability to perform normal
daily activities. These tests will be done at the start of the study, on days 3 and 7
(also days 2, 4, 5, and 6 if patients are still in the hospital), at discharge, and at
follow-up visits. The tests involve answering a number of questions and performing
simple tasks, such as squeezing a hand or lifting a foot.
- Patients who develop weakness in their arms or legs will also have the following
studies:
1. Electromyography (EMG) to study the electrical activity of the muscle. For this
test, needles are placed into a muscle to record the electrical activity at that
site.
2. Nerve conduction studies to measure how well the nerves are working. A small
charge of electricity is delivered to a nerve in the affected limb, triggering a
muscle to tighten or bend. Small wire electrodes are attached to the skin to
measure the time is takes for the nerve to move the electrical current from one
part of the limb to another.
3. Spinal MRI to see if the virus is affecting the spinal cord.
Results of other tests done by the patient's local doctor (such as lumbar puncture,
electroencephalogram, x-rays, etc.) will be requested. If a lumbar puncture is done, a small
amount of cerebrospinal fluid will be requested for testing for WNV.
|
