Home
Search
Study Topics
Glossary
|
|
|
|
|
|
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 |
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 |
Study ID Numbers: | ACTG 172 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00000635 |
Health Authority: | United States: Federal Government |
Bacitracin Polymyxin B Trifluridine AIDS-Related Opportunistic Infections Herpesviridae Infections |
Drug Evaluation Acquired Immunodeficiency Syndrome Anti-Infective Agents, Local Antiviral Agents |
Herpes Simplex Opportunistic Infections Sexually Transmitted Diseases, Viral Polymyxin B Skin Diseases Acquired Immunodeficiency Syndrome Bacitracin Immunologic Deficiency Syndromes Trifluridine Herpesviridae Infections |
Virus Diseases Skin Diseases, Infectious Polymyxins Acyclovir HIV Infections Zinc AIDS-Related Opportunistic Infections Sexually Transmitted Diseases DNA Virus Infections Retroviridae Infections |
Antimetabolites Anti-Infective Agents RNA Virus Infections Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Immune System Diseases Infection |
Antiviral Agents Pharmacologic Actions Skin Diseases, Viral Anti-Bacterial Agents Anti-Infective Agents, Local Therapeutic Uses Lentivirus Infections |