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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Glaxo Wellcome |
Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000635 |
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 | Intervention |
Herpes Simplex HIV Infections |
Drug: Trifluridine Drug: Bacitracin zinc/Polymyxin B sulfate |
MedlinePlus related topics: | AIDS Herpes Simplex |
Drug Information available for: | Acyclovir Acyclovir sodium Bacitracin Bacitracin zinc Polymyxin B Polymyxin B Sulfate Trifluridine |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Safety Study |
Official Title: | Treatment of Acyclovir-Resistant Mucocutaneous Herpes Simplex Disease in Patients With AIDS: Open Label Pilot Study of Topical Trifluridine |
Estimated Enrollment: | 25 |
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.
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication: Included:
Patients must have the following:
Allowed:
Exclusion Criteria
Concurrent Medication:
Excluded:
Patients with the following are excluded:
Prior Medication:
Excluded:
United States, Alabama | |||||
Univ of Alabama at Birmingham | |||||
Birmingham, Alabama, United States, 35294 | |||||
United States, Colorado | |||||
Univ of Colorado Health Sciences Ctr | |||||
Denver, Colorado, United States, 80262 | |||||
United States, Maryland | |||||
Johns Hopkins Hosp | |||||
Baltimore, Maryland, United States, 21287 | |||||
United States, New York | |||||
SUNY - Stony Brook | |||||
Stony Brook, New York, United States, 117948153 | |||||
Bellevue Hosp / New York Univ Med Ctr | |||||
New York, New York, United States, 10016 | |||||
Saint Luke's - Roosevelt Hosp Ctr | |||||
New York, New York, United States, 10025 | |||||
United States, South Carolina | |||||
Julio Arroyo | |||||
West Columbia, South Carolina, United States, 29169 |
Study Chair: | Kessler H A |
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)
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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.
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Study ID Numbers: | ACTG 172 |
First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00000635 |
Health Authority: | United States: Federal Government |
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