The Safety and Effectiveness of Cidofovir in the Treatment of Venereal Warts in HIV-Infected Patients

Inclusion Criteria

Concurrent Medication:

Allowed:

• AZT, ddI, ddC, d4T, or 3TC.
• Oral trimethoprim/sulfamethoxazole.
• Aerosolized pentamidine.
• Dapsone.
• Fluconazole.
• Rifabutin.
• Clarithromycin.

Patients must have:

• HIV seropositivity.
• Mean CD4 count >= 100 cells/mm3.
• External anogenital condyloma acuminatum confirmed by biopsy, present for less than 1 year. NOTE:
• Warts on anal, urethral, or vaginal mucosa will not be studied.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Active lesions of genital herpes, other skin wounds, or active inflammatory skin disorders in the same area as warts to be treated.
• Active medical problems sufficient to hinder study compliance.

Concurrent Medication:

Excluded:

• Podofilox or any podophyllum resin preparation.
• Liquid nitrogen treatment.
• Interferon alpha.
• Trichloracetic acid.
• Other treatments, topical or systemic, surgical or ablative, known to have anti-papilloma activity.
• Other investigative drugs (except d4T or 3TC) unless approved by the sponsor.

Patients with the following prior conditions are excluded:

History of untreated syphilis or Bowenoid papulosis.

Prior Medication:

Excluded within 4 weeks prior to study entry:

• Treatment for anogenital warts.
• Immunomodulators (including interferons or systemic corticosteroids).
• Lymphocyte replacement therapy.
• Biologic response modifiers. Substance abuse.