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| Sponsor: | Gilead Sciences |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002327 |
Purpose
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 |
|---|---|---|
|
HIV Infections Condyloma Acuminata |
Drug: Cidofovir |
Phase I |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study 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 |
| 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.
Eligibility| 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:
Contacts and Locations| 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 | |
More Information
| ClinicalTrials.gov Identifier: | NCT00002327 History of Changes |
| Other Study ID Numbers: | 219A, GS-93-302 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
|
AIDS-Related Opportunistic Infections Acquired Immunodeficiency Syndrome AIDS-Related Complex |
Antiviral Agents Condylomata Acuminata cidofovir |
|
HIV Infections Acquired Immunodeficiency Syndrome Condylomata Acuminata 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 Warts Papillomavirus Infections DNA Virus Infections |
Skin Diseases, Viral Tumor Virus Infections Skin Diseases, Infectious Skin Diseases Cidofovir Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antiviral Agents Anti-Infective Agents Radiation-Sensitizing Agents Physiological Effects of Drugs Anti-HIV Agents Anti-Retroviral Agents |