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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002327
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: August 1997
  Purpose

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 Intervention Phase
HIV Infections
Condyloma Acuminata
Drug: Cidofovir
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
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 NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 40
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002327

Locations
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
Pacific Med Ctr
Seattle, Washington, United States, 98144
Univ of Washington / Viral Disease Clinic
Seattle, Washington, United States, 98122
Sponsors and Collaborators
Gilead Sciences
  More Information

Publications:
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)

ClinicalTrials.gov Identifier: NCT00002327     History of Changes
Other Study ID Numbers: 219A, GS-93-302
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on October 20, 2014