Treatment of Acyclovir-Resistant Mucocutaneous Herpes Simplex Disease in Patients With AIDS: Open Label Pilot Study of Topical Trifluridine
Information source: National Institute of Allergy and Infectious Diseases (NIAID)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Herpes Simplex; HIV Infections
Intervention: Trifluridine (Drug); Bacitracin zinc/Polymyxin B sulfate (Drug)
Phase: N/A
Status: Completed
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID) Official(s) and/or principal investigator(s):
Kessler H A, Study Chair
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.
Clinical Details
Official title: Treatment of Acyclovir-Resistant Mucocutaneous Herpes Simplex Disease in Patients With AIDS: Open Label Pilot Study of Topical Trifluridine
Study design: Treatment, Open Label, Safety Study
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.
Eligibility
Minimum age: 13 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Univ of Alabama at Birmingham, Birmingham, Alabama 35294, United States
Univ of Colorado Health Sciences Ctr, Denver, Colorado 80262, United States
Johns Hopkins Hosp, Baltimore, Maryland 21287, United States
SUNY - Stony Brook, Stony Brook, New York 117948153, United States
Bellevue Hosp / New York Univ Med Ctr, New York, New York 10016, United States
Saint Luke's - Roosevelt Hosp Ctr, New York, New York 10025, United States
Julio Arroyo, West Columbia, South Carolina 29169, United States
Additional Information
Related publications: Kessler H, Weaver D, Benson C, Pottage J, Safrin S, Nevin T, Davis R, Owens S, Korvick J. ACTG 172: treatment of acyclovir-resistant (ACV-R) mucocutaneous herpes simplex virus (HSV) infection in patients with AIDS: open label pilot study of topical trifluridine (TFT). Int Conf AIDS. 1992 Jul 19-24;8(1):We55 (abstract no WeB 1056) Kessler HA, Hurwitz S, Farthing C, Benson CA, Feinberg J, Kuritzkes DR, Bailey TC, Safrin S, Steigbigel RT, Cheeseman SH, McKinley GF, Wettlaufer B, Owens S, Nevin T, Korvick JA. Pilot study of topical trifluridine for the treatment of acyclovir-resistant mucocutaneous herpes simplex disease in patients with AIDS (ACTG 172). AIDS Clinical Trials Group. J Acquir Immune Defic Syndr Hum Retrovirol. 1996 Jun 1;12(2):147-52.
Last updated: June 23, 2005
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