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 Condyloma Acuminatum in Patients With HIV Infection

Inclusion Criteria

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.