Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002327
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
The Safety and Effectiveness of Cidofovir in the Treatment of Venereal Warts in HIV-Infected Patients
Sponsor:
Gilead Sciences
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Phase III Study of the Safety and Efficacy of Topical 1-S-3-Hydroxy-2-PhosphonylmethoxypropylCytosine Dihydrate Cidofovir HPMPC in the Treatment of Condyloma Acuminatum in Patients With HIV Infection
Status:
COMPLETED
Status Verified Date:
1997-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 03 percent concentration for 5 or 10 days total or 10 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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GS-93-302 | None | None | None |