Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002186
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
Double-Blind Placebo-Controlled Study Comparing the Combination of 15 SP-303 Gel With Acyclovir Versus Acyclovir Alone for the Treatment of Recurrent Herpes Simplex Virus HSV Infections in Subjects With Acquired Immunodeficiency Syndrome AIDS
Sponsor:
Shaman Pharmaceuticals
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
Double-Blind Placebo-Controlled Study Comparing the Combination of 15 SP-303 Gel With Acyclovir Versus Acyclovir Alone for the Treatment of Recurrent Herpes Simplex Virus HSV Infections in Subjects With Acquired Immunodeficiency Syndrome AIDS
Status:
COMPLETED
Status Verified Date:
1998-02
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 of topically applied SP-303 gel and to compare the efficacy of SP-303 gel in combination with acyclovir relative to acyclovir alone for the treatment of recurrent Herpes Simplex Virus HSV 1 and 2 infections affecting the genital perianal and neighboring areas in patients with AIDS
Detailed Description:
This trial is a double-blind multicenter placebo-controlled clinical trial Participants are randomized to topical 15 SP-303 gel and oral acyclovir or to matching topical placebo gel and oral acyclovir At presentation patients are stratified by total lesion area within each treatment group SP-303 or matching placebo is topically applied three times a day until all lesions are reepithelialized or for 14 days whichever occurs earlier Acyclovir is administered by mouth each day three times a day until all lesions are reepithelialized or for 14 days whichever occurs earlier Patients are evaluated for lesion healing and adverse events 3 times per week during the treatment period The primary efficacy endpoint will be complete lesion healing and the primary analysis will be time to complete healing
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 |
|---|---|---|---|
| 96-867-DE | None | None | None |