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Sponsored by: |
Gilead Sciences |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002327 |
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.
Condition | Intervention | Phase |
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HIV Infections Condyloma Acuminata |
Drug: Cidofovir |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Dose Comparison, Safety Study |
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 |
Estimated Enrollment: | 40 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
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:
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 | |
Univ of Rochester Med Ctr | |
Rochester, New York, United States, 14642 | |
Bronx-Lebanon Hosp Ctr | |
Bronx, New York, United States, 10453 | |
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 |
Study ID Numbers: | 219A, GS-93-302 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002327 |
Health Authority: | United States: Food and Drug Administration |
AIDS-Related Opportunistic Infections Acquired Immunodeficiency Syndrome AIDS-Related Complex |
Antiviral Agents Condylomata Acuminata cidofovir |
Cidofovir Opportunistic Infections Sexually Transmitted Diseases, Viral Skin Diseases Acquired Immunodeficiency Syndrome Condyloma AIDS-Related Complex Immunologic Deficiency Syndromes Virus Diseases Skin Diseases, Infectious |
Warts HIV Infections Condyloma acuminatum Condylomata Acuminata AIDS-Related Opportunistic Infections Sexually Transmitted Diseases DNA Virus Infections Papillomavirus Infections Retroviridae Infections |
Communicable Diseases Anti-Infective Agents RNA Virus Infections Anti-HIV Agents Slow Virus Diseases Immune System Diseases Antineoplastic Agents Physiological Effects of Drugs Tumor Virus Infections |
Infection Antiviral Agents Pharmacologic Actions Skin Diseases, Viral Anti-Retroviral Agents Radiation-Sensitizing Agents Therapeutic Uses Lentivirus Infections |