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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002327
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Information provided by:
NIH AIDS Clinical Trials Information Service

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
HIV Infections Condyloma Acuminata Drug: Cidofovir Phase 1

Detailed Description:
Four groups of 10 patients each receive topical HPMPC at 0.3 percent concentration for 5 or 10 days total or 1.0 percent concentration for 5 or 10 days total, followed by 2 weeks of rest. When six patients at a given dose and schedule have completed treatment and follow-up without significant toxicity, subsequent patients are entered at the next higher dose level. Patients are evaluated twice weekly during treatment and once weekly during the rest period. HPMPC may be extended for up to two additional courses in patients who experience no significant toxicity.

Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Primary Purpose: Treatment
Official Title: 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Cidofovir

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

Concurrent Medication:


  • 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:


  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002327

United States, California
East Bay AIDS Ctr
Berkeley, California, United States, 94705
Univ California San Francisco
San Francisco, California, United States, 941430316
United States, Colorado
City and County of Denver / Dept of Health & Hosps
Denver, Colorado, United States, 802044507
United States, New York
Bronx-Lebanon Hosp Ctr
Bronx, New York, United States, 10453
Univ of Rochester Med Ctr
Rochester, New York, United States, 14642
United States, Texas
Houston Clinical Research Network
Houston, Texas, United States, 77006
Dr Brad Bowden
Houston, Texas, United States, 77027
Dr Stephen Tyring
Nassau Bay, Texas, United States, 77058
United States, Utah
Univ of Utah School of Medicine
Salt Lake City, Utah, United States, 84132
United States, Washington
Univ of Washington / Viral Disease Clinic
Seattle, Washington, United States, 98122
Pacific Med Ctr
Seattle, Washington, United States, 98144
Sponsors and Collaborators
Gilead Sciences

Douglas J, Corey L, Tyring S, Kriesel J, Bowden B, Crosby D, Berger T, Conant M, McGuire B, Jaffe HS. A phase I/II study of cidofovir topical gel for refractory condyloma acuminatum in patients with HIV infection. Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:126 (abstract no 334) Identifier: NCT00002327     History of Changes
Other Study ID Numbers: 219A
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: August 1997

Keywords provided by NIH AIDS Clinical Trials Information Service:
AIDS-Related Opportunistic Infections
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Antiviral Agents
Condylomata Acuminata

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Antiviral Agents
Anti-Infective Agents