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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)
ClinicalTrials.gov processed this data on August 23, 2015
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: Endpoint Classification: Safety Study, Masking: Open Label, Primary Purpose: Treatment

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

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

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: March 29, 2012

Page last updated: August 23, 2015

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