Clinical Trials Related to Trifluridine (Trifluridine Ophthalmic)
Treatment of Acyclovir-Resistant Mucocutaneous Herpes Simplex Disease in Patients With AIDS: Open Label Pilot Study of Topical Trifluridine [Completed]
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 ) disease that has shown resistance to acyclovir in HIV-infected patients. HSV
infection in patients with AIDS is often associated with skin sores and frequent recurrences.
Treatment with the drug acyclovir results in healing for most patients, but repeated
treatment sometimes results in resistance of the virus to acyclovir. Thus, when this happens,
other treatments need to be used. Trifluridine is an antiviral drug that is used for the
treatment of Herpes infections that occur in the eye. This study attempts to determine if
trifluridine is useful for treating HSV sores that have not healed after treatment with
Evaluation of the Therapeutic Benefit of r-metHuIFN- Gamma in AIDS Patients With Disseminated Mycobacterium Avium-Intracellulare (MAI) Infection: A Multi-Centered Pilot Study [Completed]
Herpetic Eye Disease Study (HEDS) I [Completed]
To evaluate the efficacy of topical corticosteroids in treating herpes simplex stromal
keratitis in conjunction with topical trifluridine.
To evaluate the efficacy of oral acyclovir in treating herpes simplex stromal keratitis in
patients receiving concomitant topical corticosteroids and trifluridine.
To evaluate the efficacy of oral acyclovir in treating herpes simplex iridocyclitis in
conjunction with treatment with topical corticosteroids and trifluridine.
Evaluation and Treatment of Eye Complications of Vaccinia Vaccination [Completed]
This study will evaluate patients with eye complications related to vaccination against
smallpox to learn more about these conditions. Vaccinia vaccination has been used for more
than 100 years for preventing smallpox. A small number of people who receive the vaccination
(less than 1 in 1,000) develop complications, sometimes in their eyes. This usually results
from the accidental transfer of the infection from the vaccination site to the face or eyes,
perhaps by touching the vaccination area and then the face or eyelids before washing the
hands. The study will also examine whether an experimental treatment called NP-016 vaccinia
immune globulin can reduce corneal scarring that is sometimes associated with serious
vaccinia complications and can impair vision.
Children and adults with keratitis, severe conjunctivitis, or blepharitis following exposure
to vaccinia vaccination may be eligible for this study. Children must weigh at least 10 kg.
Participants undergo the following tests and procedures at enrollment, with some tests
repeated at scheduled study visits:
1. Medical history and physical examination
2. Infectious disease consultation
3. Complete eye evaluation including:
- Fundus photography to examine the back of the eye - dilation of the pupils with eye
drops to examine and photograph the back of the eye
- Slit lamp biomicroscopy - evaluation of the front part of the eye with a slit lamp
- Eye pressure measurements
- Eye swab to look for vaccinia virus or other causes of disease
4. Blood tests
5. Photographs and documentation of eye and skin lesions
6. Vaccinia diagnostic tests, such as skin or mucosa scrapings; blood, throat, or urine
cultures; and tissue biopsies, if needed
Patients begin treatment with standard medications for their eye disease, such as
trifluridine (Viroptic® (Registered Trademark)) anti-viral eye drops. Patients whose
condition becomes serious are offered additional treatment with intravenous (through a vein)
infusions of either VIG or placebo (salt water solution with no active drug) and are randomly
assigned to one or the other treatment group. All patients continue standard-of-care
treatment as well.
Follow-up visits at the NIH eye clinic are scheduled as required by the patient's condition.
Patients with mild complications who are taking only standard medications may need to be seen
only 1 month after the initial visit and then 6 months and 12 months later. Patients with
more serious conditions who qualify for VIG or placebo treatments may be seen daily for a
week, then once a week for the rest of the first month, and then at 6 months and 12 months,
unless more frequent treatment or observation is required.