The Safety and Effectiveness of Cidofovir in the Treatment of Venereal Warts in HIV-Infected Patients
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ClinicalTrials.gov Identifier: NCT00002327 |
Recruitment Status
:
Completed
First Posted
: August 31, 2001
Last Update Posted
: June 24, 2005
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections Condyloma Acuminata | Drug: Cidofovir | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 40 participants |
Primary Purpose: | Treatment |
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 |


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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002327
United States, California | |
East Bay AIDS Ctr | |
Berkeley, California, United States, 94705 | |
Univ California San Francisco | |
San Francisco, California, United States, 941430316 | |
United States, Colorado | |
City and County of Denver / Dept of Health & Hosps | |
Denver, Colorado, United States, 802044507 | |
United States, New York | |
Bronx-Lebanon Hosp Ctr | |
Bronx, New York, United States, 10453 | |
Univ of Rochester Med Ctr | |
Rochester, New York, United States, 14642 | |
United States, Texas | |
Houston Clinical Research Network | |
Houston, Texas, United States, 77006 | |
Dr Brad Bowden | |
Houston, Texas, United States, 77027 | |
Dr Stephen Tyring | |
Nassau Bay, Texas, United States, 77058 | |
United States, Utah | |
Univ of Utah School of Medicine | |
Salt Lake City, Utah, United States, 84132 | |
United States, Washington | |
Univ of Washington / Viral Disease Clinic | |
Seattle, Washington, United States, 98122 | |
Pacific Med Ctr | |
Seattle, Washington, United States, 98144 |
Publications:
ClinicalTrials.gov Identifier: | NCT00002327 History of Changes |
Other Study ID Numbers: |
219A GS-93-302 |
First Posted: | August 31, 2001 Key Record Dates |
Last Update Posted: | June 24, 2005 |
Last Verified: | August 1997 |
Keywords provided by NIH AIDS Clinical Trials Information Service:
AIDS-Related Opportunistic Infections Acquired Immunodeficiency Syndrome AIDS-Related Complex |
Antiviral Agents Condylomata Acuminata cidofovir |
Additional relevant MeSH terms:
Infection HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral |
Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Cidofovir Antiviral Agents Anti-Infective Agents |