A Phase I/II Study of the Safety and Efficacy of Topical 1-(S)-(3-Hydroxy-2-Phosphonylmethoxypropyl)Cytosine Dihydrate (Cidofovir; HPMPC) in the Treatment of Refractory Mucocutaneous Herpes Simplex Disease in Patients With AIDS

Inclusion Criteria

Concurrent Medication:

Allowed:

• Antiretroviral therapy with AZT, ddI, ddC, or d4T.
• Oral trimethoprim/sulfamethoxazole.
• Dapsone.
• Atovaquone.
• Fluconazole.
• Rifabutin.
• Clarithromycin.

Patients must have:

• HIV seropositivity.
• Mucocutaneous herpes simplex virus (HSV) infection confirmed by previous viral culture and persisting without improvement despite at least 10 days of acyclovir at a minimum dose of 1 g/day (oral) or 15 mg/kg/day (intravenous).
• Measurable lesions.
• Consent of parent or guardian if less than 18 years of age.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

Active medical problems sufficient to hinder study compliance or assessment of treatment effect.

Concurrent Medication:

Excluded:

• Acyclovir.
• Immunomodulators (such as corticosteroids or interferons).
• Lymphocyte replacement therapy.
• Biologic response modifiers.
• Ganciclovir.
• Foscarnet.
• Vidarabine.
• Topical trifluridine.
• Other investigational drugs (except d4T).
• Amphotericin.
• Intravenous therapy for PCP.
• Chemotherapeutic agents.

Prior Medication:

Excluded within 14 days prior to study entry:

• Immunomodulators (such as corticosteroids or interferons).
• Lymphocyte replacement therapy.
• Biologic response modifiers.
• Ganciclovir.
• Foscarnet.
• Vidarabine.
• Topical trifluridine.
• Other investigational drugs with potential anti-HSV activity.
• Amphotericin.
• Intravenous therapy for PCP.

Excluded within 4 weeks prior to study entry:

• Chemotherapeutic agents.

Required:

• At least 10 days of prior acyclovir at a minimum dose of 1 g/day (oral) or 15 mg/kg/day (intravenous).

Substance abuse.