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

NCT ID: NCT00002327

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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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.

Conditions

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HIV Infections Condyloma Acuminata

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Cidofovir

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gilead Sciences

INDUSTRY

Sponsor Role lead

Locations

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East Bay AIDS Ctr

Berkeley, California, United States

Site Status

Univ California San Francisco

San Francisco, California, United States

Site Status

City and County of Denver / Dept of Health & Hosps

Denver, Colorado, United States

Site Status

Univ of Rochester Med Ctr

Rochester, New York, United States

Site Status

Bronx-Lebanon Hosp Ctr

The Bronx, New York, United States

Site Status

Houston Clinical Research Network

Houston, Texas, United States

Site Status

Dr Brad Bowden

Houston, Texas, United States

Site Status

Dr Stephen Tyring

Nassau Bay, Texas, United States

Site Status

Univ of Utah School of Medicine

Salt Lake City, Utah, United States

Site Status

Univ of Washington / Viral Disease Clinic

Seattle, Washington, United States

Site Status

Pacific Med Ctr

Seattle, Washington, United States

Site Status

Countries

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United States

References

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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)

Reference Type BACKGROUND

Other Identifiers

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GS-93-302

Identifier Type: -

Identifier Source: secondary_id

219A

Identifier Type: -

Identifier Source: org_study_id