NCT00002327

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (planned)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV Infections
• Condyloma Acuminata

Interventions

Type	Name	Description
DRUG	Cidofovir

Timeline

• First posted: 2001-08-31
• Last updated: 2005-06-24

Locations

11 sites across 1 country: United States