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

NCT00000635 | Completed

• 2 other identifiers: ACTG 17211147
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Herpes Simplex; HIV Infections

Keywords

Bacitracin; Polymyxin B; Trifluridine; AIDS-Related Opportunistic Infections; Herpesviridae Infections; Drug Evaluation; Acquired Immunodeficiency Syndrome; Anti-Infective Agents, Local; Antiviral Agents

Interventions

Trifluridine DRUG

Bacitracin zinc/Polymyxin B sulfate DRUG

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Glaxo Wellcome: collaborator

Study Sites (8)

Ucsf Aids Crs

San Francisco, California, United States

Location

University of Colorado Hospital CRS

Aurora, Colorado, United States

Location

Cook County Hosp. CORE Ctr.

Chicago, Illinois, United States

Location

Northwestern University CRS

Chicago, Illinois, United States

Location

Rush Univ. Med. Ctr. ACTG CRS

Chicago, Illinois, United States

Location

Johns Hopkins Adult AIDS CRS

Baltimore, Maryland, 21287, United States

Location

Washington U CRS

St Louis, Missouri, United States

Location

NY Univ. HIV/AIDS CRS

New York, New York, 10016, United States

Location

Related Publications (2)

• 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)

  BACKGROUND

• 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.

  PMID: 8680885 BACKGROUND

MeSH Terms

Conditions

Herpes Simplex; HIV Infections; AIDS-Related Opportunistic Infections; Herpesviridae Infections; Acquired Immunodeficiency Syndrome

Interventions

Trifluridine; bacitracin zinc, neomycin sulfate, polymyxin B, drug combination

Condition Hierarchy (Ancestors)

DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Opportunistic Infections; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Kessler H A

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: April 1, 1992
• Last Updated: November 2, 2021

Record last verified: 2021-10

Locations

US (8)