Treatment of Acyclovir-Resistant Mucocutaneous Herpes Simplex Disease in Patients With AIDS: Openā¦ (NCT00000635) | Clinical Trial Compass
CompletedNot Applicable
Treatment of Acyclovir-Resistant Mucocutaneous Herpes Simplex Disease in Patients With AIDS: Open Label Pilot Study of Topical Trifluridine
United States25 participants
Plain-language 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.
Who can participate
Age range13 Years
SexALL
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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.
Trial details
NCT IDNCT00000635
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)