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

Primary Purpose

Herpes Simplex, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Trifluridine
Bacitracin zinc/Polymyxin B sulfate
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Herpes Simplex focused on measuring Bacitracin, Polymyxin B, Trifluridine, AIDS-Related Opportunistic Infections, Herpesviridae Infections, Drug Evaluation, Acquired Immunodeficiency Syndrome, Anti-Infective Agents, Local, Antiviral Agents

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ucsf Aids Crs
  • University of Colorado Hospital CRS
  • Cook County Hosp. CORE Ctr.
  • Northwestern University CRS
  • Rush Univ. Med. Ctr. ACTG CRS
  • Johns Hopkins Adult AIDS CRS
  • Washington U CRS
  • NY Univ. HIV/AIDS CRS

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 26, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Glaxo Wellcome
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1. Study Identification

Unique Protocol Identification Number
NCT00000635
Brief Title
Treatment of Acyclovir-Resistant Mucocutaneous Herpes Simplex Disease in Patients With AIDS: Open Label Pilot Study of Topical Trifluridine
Official Title
Treatment of Acyclovir-Resistant Mucocutaneous Herpes Simplex Disease in Patients With AIDS: Open Label Pilot Study of Topical Trifluridine
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 1992 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Glaxo Wellcome

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
None (Open Label)
Enrollment
25 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Trifluridine
Intervention Type
Drug
Intervention Name(s)
Bacitracin zinc/Polymyxin B sulfate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kessler H A
Official's Role
Study Chair
Facility Information:
Facility Name
Ucsf Aids Crs
City
San Francisco
State/Province
California
Country
United States
Facility Name
University of Colorado Hospital CRS
City
Aurora
State/Province
Colorado
Country
United States
Facility Name
Cook County Hosp. CORE Ctr.
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Northwestern University CRS
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Rush Univ. Med. Ctr. ACTG CRS
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Johns Hopkins Adult AIDS CRS
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Washington U CRS
City
Saint Louis
State/Province
Missouri
Country
United States
Facility Name
NY Univ. HIV/AIDS CRS
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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)
Results Reference
background
PubMed Identifier
8680885
Citation
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.
Results Reference
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Treatment of Acyclovir-Resistant Mucocutaneous Herpes Simplex Disease in Patients With AIDS: Open Label Pilot Study of Topical Trifluridine

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