Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002116
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief 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 Refractory Mucocutaneous Herpes Simplex Disease in Patients With AIDS
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 Refractory Mucocutaneous Herpes Simplex Disease in Patients With AIDS
Status:
COMPLETED
Status Verified Date:
1995-12
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 refractory mucocutaneous herpes simplex virus disease in AIDS patients To determine whether topical HPMPC therapy can induce re-epithelialization and healing of refractory mucocutaneous herpes simplex virus disease in AIDS patients To evaluate the virologic effects of topical HPMPC therapy on herpes simplex virus shedding from refractory lesions
Detailed Description:
Patients are randomized to receive topical therapy with placebo vehicle alone or HPMPC at either 03 or 10 percent once daily for 5 days Patients are assessed to day 15 those with no significant toxicity are eligible to receive open-label topical HPMPC for up to 6 months
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-93-301 | None | None | None |