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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002327
• Other study ID #: 219A
• Secondary ID: GS-93-302
• Status: Completed
• Phase: Phase 1
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: August 1997
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Condyloma Acuminata
• HIV Infections
• Infection

Intervention

Drug:
• Cidofovir

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

United States, 

References & Publications (1)

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)