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

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

Sponsors

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator: Glaxo Wellcome

Source National Institute of Allergy and Infectious Diseases (NIAID)
Brief Summary

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 acyclovir.

Detailed Description

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 acyclovir.

Patients receive at least 10 days (and up to 42 days) of treatment with topical trifluridine. Trifluridine is applied in a thin fluid layer that overlaps the edges of the lesion. Polymyxin B sulfate/bacitracin zinc ointment is then applied over the trifluridine. Lesions are covered by a nonabsorbent dressing. Medication is applied every 8 hours.

Overall Status Completed
Completion Date April 1992
Phase N/A
Study Type Interventional
Enrollment 25
Condition
Intervention

Intervention Type: Drug

Intervention Name: Trifluridine

Intervention Type: Drug

Intervention Name: Bacitracin zinc/Polymyxin B sulfate

Eligibility

Criteria:

Inclusion Criteria

Concurrent Medication: Included:

- All medications deemed essential for best patient care, including zidovudine (AZT), Pneumocystis carinii pneumonia (PCP) prophylaxis, and acute or maintenance therapies for other opportunistic infections.

Patients must have the following:

- HIV infection or diagnosis of AIDS.

- Mucocutaneous Herpes simplex virus infection.

- Ability to give informed consent.

Allowed:

- Patients may be co-enrolled in other ACTG studies except for those in which treatments are expected to generate neutropenia. Subjects aged 13 - 17 may be enrolled with appropriate consent from parent or guardian.

Exclusion Criteria

Concurrent Medication:

Excluded:

- Acyclovir, ganciclovir, foscarnet, vidarabine or other investigational drugs with potential anti-Herpes simplex virus activity.

Patients with the following are excluded:

- Previous hypersensitivity reaction to trifluridine, polymyxin B or bacitracin.

Prior Medication:

Excluded:

- Immunomodulators, lymphocyte replacement therapy or biologic response modifiers within 14 days prior to study entry.

Gender: All

Minimum Age: 13 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role
Kessler H A Study Chair
Location
Facility:
Ucsf Aids Crs | San Francisco, California, United States
University of Colorado Hospital CRS | Aurora, Colorado, United States
Cook County Hosp. CORE Ctr. | Chicago, Illinois, United States
Northwestern University CRS | Chicago, Illinois, United States
Rush Univ. Med. Ctr. ACTG CRS | Chicago, Illinois, United States
Johns Hopkins Adult AIDS CRS | Baltimore, Maryland, 21287, United States
Washington U CRS | St. Louis, Missouri, United States
NY Univ. HIV/AIDS CRS | New York, New York, 10016, United States
Location Countries

United States

Verification Date

March 2012

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Study Design Info

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov