A Phase 1 interventional study of Cidofovir in HIV Infections and Condyloma Acuminata, sponsored by Gilead Sciences. Completed at 11 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2005-06-24.
Sponsored by Gilead Sciences · Phase 1, Interventional, and Treatment
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.
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 40 is below the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Gilead Sciences is the lead sponsor of 680 studies on the registry; 24 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 249 (96%) have results posted.
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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:
This study is completed, as verified in Aug 1997. You cannot join it, but the record below documents what was studied.
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