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Home > "T" Clinical Trials Conditions > The Safety and Effectiveness of Cidofovir in the Treatment of Venereal Warts in HIV-Infected Patients  The Safety and Effectiveness of Cidofovir in the Treatment of Venereal Warts in HIV-Infected Patients
The Safety and Effectiveness of Cidofovir in the Treatment of Venereal Warts in HIV-Infected Patients
For Condition: HIV Infections,Condyloma Acuminata
Status: Completed
Sponsor(s): Gilead Sciences ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Dose Comparison, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 40
Location and Contact Information:
Bronx-Lebanon Hosp Ctr
Bronx, New York, 10453
United States
Dr Stephen Tyring
Nassau Bay, Texas, 77058
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
Univ of Washington / Viral Disease Clinic
Seattle, Washington, 98122
United States
East Bay AIDS Ctr
Berkeley, California, 94705
United States
Houston Clinical Research Network
Houston, Texas, 77006
United States
Univ of Utah School of Medicine
Salt Lake City, Utah, 84132
United States
Dr Brad Bowden
Houston, Texas, 77027
United States
Pacific Med Ctr
Seattle, Washington, 98144
United States
Additional Information:
Study ID Numbers: 219A; GS-93-302
Study Start Date:
Record last reviewed: August 1997
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002327
Other Condyloma Acuminata Studies:
1. The Safety and Effectiveness of Cidofovir in the Treatment of Venereal Warts in HIV-Infected Patients
Related Studies:
Other Condyloma Acuminata Clinical Trials
Other New York Clinical Trials
Other Rochester Clinical Trials
The Safety and Effectiveness of Cidofovir in the Treatment of Venereal Warts in HIV-Infected Patients
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