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

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

Overall Status

Completed

CT.gov ID

NCT00000635

Collaborator

Glaxo Wellcome (Industry)

Enrollment

Locations

3.1

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Herpes Simplex HIV Infections	Drug: Trifluridine Drug: Bacitracin zinc/Polymyxin B sulfate	N/A

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.

Study Design

Study Type:

Interventional

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Completion Date :

Apr 1, 1992

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ucsf Aids Crs	San Francisco	California	United States
2	University of Colorado Hospital CRS	Aurora	Colorado	United States
3	Cook County Hosp. CORE Ctr.	Chicago	Illinois	United States
4	Northwestern University CRS	Chicago	Illinois	United States
5	Rush Univ. Med. Ctr. ACTG CRS	Chicago	Illinois	United States
6	Johns Hopkins Adult AIDS CRS	Baltimore	Maryland	United States	21287
7	Washington U CRS	Saint Louis	Missouri	United States
8	NY Univ. HIV/AIDS CRS	New York	New York	United States	10016