The Safety and Effectiveness of Cidofovir in the Treatment of Venereal Warts in HIV-Infected Patients
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
2 other identifiers
interventional
40
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 hiv-infections
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
August 1, 1997
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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:
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (11)
East Bay AIDS Ctr
Berkeley, California, 94705, United States
Univ California San Francisco
San Francisco, California, 941430316, United States
City and County of Denver / Dept of Health & Hosps
Denver, Colorado, 802044507, United States
Univ of Rochester Med Ctr
Rochester, New York, 14642, United States
Bronx-Lebanon Hosp Ctr
The Bronx, New York, 10453, United States
Houston Clinical Research Network
Houston, Texas, 77006, United States
Dr Brad Bowden
Houston, Texas, 77027, United States
Dr Stephen Tyring
Nassau Bay, Texas, 77058, United States
Univ of Utah School of Medicine
Salt Lake City, Utah, 84132, United States
Univ of Washington / Viral Disease Clinic
Seattle, Washington, 98122, United States
Pacific Med Ctr
Seattle, Washington, 98144, United States
Related 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)
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1997-08