- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00000635
Treatment of Acyclovir-Resistant Mucocutaneous Herpes Simplex Disease in Patients With AIDS: Open Label Pilot Study of Topical Trifluridine
Study Overview
Status
Conditions
Intervention / 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.
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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San Francisco, California, United States
- Ucsf Aids Crs
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Colorado
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Aurora, Colorado, United States
- University of Colorado Hospital CRS
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Illinois
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Chicago, Illinois, United States
- Cook County Hosp. CORE Ctr.
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Chicago, Illinois, United States
- Northwestern University CRS
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Chicago, Illinois, United States
- Rush Univ. Med. Ctr. ACTG CRS
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Maryland
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Baltimore, Maryland, United States, 21287
- Johns Hopkins Adult AIDS CRS
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Missouri
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Saint Louis, Missouri, United States
- Washington U CRS
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New York
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New York, New York, United States, 10016
- NY Univ. HIV/AIDS CRS
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Kessler H A
Publications and helpful links
General 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. doi: 10.1097/00042560-199606010-00007.
Study record dates
Study Major Dates
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Virus Diseases
- DNA Virus Infections
- Skin Diseases, Infectious
- Skin Diseases, Viral
- Herpesviridae Infections
- Infections
- Herpes Simplex
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents, Local
- Anti-Infective Agents
- Antiviral Agents
- Antimetabolites
- Anti-Bacterial Agents
- Polymyxins
- Bacitracin
- Polymyxin B
- Trifluridine
Other Study ID Numbers
- ACTG 172
- 11147 (Registry Identifier: DAIDS ES Registry Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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