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The Safety and Effectiveness of Cidofovir in the Treatment of Venereal Warts in HIV-Infected Patients

Phase 1
Completed
Conditions
HIV Infections
Condyloma Acuminata
Registration Number
NCT00002327
Lead Sponsor
Gilead Sciences
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.

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
40
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (11)

Dr Brad Bowden

🇺🇸

Houston, Texas, United States

Pacific Med Ctr

🇺🇸

Seattle, Washington, United States

Houston Clinical Research Network

🇺🇸

Houston, Texas, United States

East Bay AIDS Ctr

🇺🇸

Berkeley, California, United States

Univ of Washington / Viral Disease Clinic

🇺🇸

Seattle, Washington, United States

Univ of Utah School of Medicine

🇺🇸

Salt Lake City, Utah, United States

Univ of Rochester Med Ctr

🇺🇸

Rochester, New York, United States

Univ California San Francisco

🇺🇸

San Francisco, California, United States

Bronx-Lebanon Hosp Ctr

🇺🇸

Bronx, New York, United States

Dr Stephen Tyring

🇺🇸

Nassau Bay, Texas, United States

City and County of Denver / Dept of Health & Hosps

🇺🇸

Denver, Colorado, United States

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