Treatment of Acyclovir-Resistant Mucocutaneous Herpes Simplex Disease in Patients With AIDS: Open Label Pilot Study of Topical Trifluridine
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Purpose
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: | Endpoint Classification: Safety Study Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Treatment of Acyclovir-Resistant Mucocutaneous Herpes Simplex Disease in Patients With AIDS: Open Label Pilot Study of Topical Trifluridine |
| Estimated Enrollment: | 25 |
| Study Completion Date: | April 1992 |
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| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| United States, California | |
| Ucsf Aids Crs | |
| San Francisco, California, United States | |
| United States, Colorado | |
| University of Colorado Hospital CRS | |
| Aurora, Colorado, United States | |
| United States, Illinois | |
| 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 | |
| United States, Maryland | |
| Johns Hopkins Adult AIDS CRS | |
| Baltimore, Maryland, United States, 21287 | |
| United States, Missouri | |
| Washington U CRS | |
| St. Louis, Missouri, United States | |
| United States, New York | |
| NY Univ. HIV/AIDS CRS | |
| New York, New York, United States, 10016 | |
| Study Chair: | Kessler H A |
More Information
Publications:
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000635 History of Changes |
| Other Study ID Numbers: | ACTG 172, 11147 |
| Study First Received: | November 2, 1999 |
| Last Updated: | March 29, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
|
Bacitracin Polymyxin B Trifluridine AIDS-Related Opportunistic Infections Herpesviridae Infections |
Drug Evaluation Acquired Immunodeficiency Syndrome Anti-Infective Agents, Local Antiviral Agents |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Herpes Simplex Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Herpesviridae Infections DNA Virus Infections Skin Diseases, Viral |
Skin Diseases, Infectious Skin Diseases Acyclovir Trifluridine Polymyxin B Anti-Infective Agents Bacitracin Polymyxins Anti-Infective Agents, Local Antiviral Agents Therapeutic Uses Pharmacologic Actions Anti-Bacterial Agents Antimetabolites Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on March 10, 2013
