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	Treatment or Intervention
Herpes Simplex HIV Infections	Drug: Trifluridine  Drug: Bacitracin zinc/Polymyxin B sulfate

Further Study Details: 

Expected Total Enrollment:  25

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.

Ages Eligible for Study:  13 Years and above,  Genders Eligible for Study:  Both

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.

Alabama
      Univ of Alabama at Birmingham, Birmingham,  Alabama,  35294,  United States
Colorado
      Univ of Colorado Health Sciences Ctr, Denver,  Colorado,  80262,  United States
Maryland
      Johns Hopkins Hosp, Baltimore,  Maryland,  21287,  United States
New York
      SUNY - Stony Brook, Stony Brook,  New York,  117948153,  United States
      Bellevue Hosp / New York Univ Med Ctr, New York,  New York,  10016,  United States
      Saint Luke's - Roosevelt Hosp Ctr, New York,  New York,  10025,  United States
South Carolina
      Julio Arroyo, West Columbia,  South Carolina,  29169,  United States

Study chairs or principal investigators

Kessler H A,  Study Chair

Study ID Numbers:  ACTG 172
Record last reviewed:  October 2003
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00000635
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08