Treatment of Acyclovir-Resistant Mucocutaneous Herpes Simplex Disease in Patients With AIDS: Open Label Pilot Study of Topical Trifluridine

This study has been completed.
Sponsor:
Collaborator:
Glaxo Wellcome
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000635
First received: November 2, 1999
Last updated: March 29, 2012
Last verified: March 2012
  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

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 25
Study Completion Date: April 1992
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

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000635

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
Sponsors and Collaborators
Glaxo Wellcome
Investigators
Study Chair: Kessler H A
  More Information

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)

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 August 01, 2014