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

Completed · Phase 1

Conditions studied: HIV Infections, Condyloma Acuminata

In brief

To evaluate the safety and tolerance of topical cidofovir (HPMPC) therapy for condyloma acuminatum in patients with HIV infection. To investigate whether topical HPMPC therapy can induce regression of condyloma acuminatum in patients with HIV infection.

Key facts

Study ID

NCT00002327

Run by

Gilead Sciences

People needed

40

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• East Bay AIDS Ctr — Berkeley, California, United States
• Univ California San Francisco — San Francisco, California, United States
• City and County of Denver / Dept of Health & Hosps — Denver, Colorado, United States
• Univ of Rochester Med Ctr — Rochester, New York, United States
• Bronx-Lebanon Hosp Ctr — The Bronx, New York, United States
• Houston Clinical Research Network — Houston, Texas, United States
• Dr Brad Bowden — Houston, Texas, United States
• Dr Stephen Tyring — Nassau Bay, Texas, United States
• Univ of Utah School of Medicine — Salt Lake City, Utah, United States
• Univ of Washington / Viral Disease Clinic — Seattle, Washington, United States
• Pacific Med Ctr — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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