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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

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...

Gender

ALL

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.