- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002327
The Safety and Effectiveness of Cidofovir in the Treatment of Venereal Warts in HIV-Infected Patients
June 23, 2005 updated by: Gilead Sciences
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment
40
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Berkeley, California, United States, 94705
- East Bay AIDS Ctr
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San Francisco, California, United States, 941430316
- Univ California San Francisco
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Colorado
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Denver, Colorado, United States, 802044507
- City and County of Denver / Dept of Health & Hosps
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New York
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Bronx, New York, United States, 10453
- Bronx-Lebanon Hosp Ctr
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Rochester, New York, United States, 14642
- Univ of Rochester Med Ctr
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Texas
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Houston, Texas, United States, 77006
- Houston Clinical Research Network
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Houston, Texas, United States, 77027
- Dr Brad Bowden
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Nassau Bay, Texas, United States, 77058
- Dr Stephen Tyring
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Utah
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Salt Lake City, Utah, United States, 84132
- Univ of Utah School of Medicine
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Washington
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Seattle, Washington, United States, 98122
- Univ of Washington / Viral Disease Clinic
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Seattle, Washington, United States, 98144
- Pacific Med Ctr
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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)
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
November 2, 1999
First Submitted That Met QC Criteria
August 30, 2001
First Posted (Estimate)
August 31, 2001
Study Record Updates
Last Update Posted (Estimate)
June 24, 2005
Last Update Submitted That Met QC Criteria
June 23, 2005
Last Verified
August 1, 1997
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Infections
- Acquired Immunodeficiency Syndrome
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Cidofovir
Other Study ID Numbers
- 219A
- GS-93-302
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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