Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000635
Status:
COMPLETED
Last Update Posted:
2021-11-02
First Post:
1999-11-02
Brief Title:
Treatment of Acyclovir-Resistant Mucocutaneous Herpes Simplex Disease in Patients With AIDS Open Label Pilot Study of Topical Trifluridine
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Treatment of Acyclovir-Resistant Mucocutaneous Herpes Simplex Disease in Patients With AIDS Open Label Pilot Study of Topical Trifluridine
Status:
COMPLETED
Status Verified Date:
2021-10
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 determine the safety effectiveness and toxicity of topical local trifluridine in treating mucocutaneous at the nasal oral vaginal and anal openings Herpes simplex virus HSV disease that has shown resistance to acyclovir in HIV-infected patients HSV infection in patients with AIDS is often associated with skin sores and frequent recurrences Treatment with the drug acyclovir results in healing for most patients but repeated treatment sometimes results in resistance of the virus to acyclovir Thus when this happens other treatments need to be used Trifluridine is an antiviral drug that is used for the treatment of Herpes infections that occur in the eye This study attempts to determine if trifluridine is useful for treating HSV sores that have not healed after treatment with acyclovir
Detailed Description:
HSV infection in patients with AIDS is often associated with skin sores and frequent recurrences Treatment with the drug acyclovir results in healing for most patients but repeated treatment sometimes results in resistance of the virus to acyclovir Thus when this happens other treatments need to be used Trifluridine is an antiviral drug that is used for the treatment of Herpes infections that occur in the eye This study attempts to determine if trifluridine is useful for treating HSV sores that have not healed after treatment with acyclovir
Patients receive at least 10 days and up to 42 days of treatment with topical trifluridine Trifluridine is applied in a thin fluid layer that overlaps the edges of the lesion Polymyxin B sulfatebacitracin zinc ointment is then applied over the trifluridine Lesions are covered by a nonabsorbent dressing Medication is applied every 8 hours
Patients receive at least 10 days and up to 42 days of treatment with topical trifluridine Trifluridine is applied in a thin fluid layer that overlaps the edges of the lesion Polymyxin B sulfatebacitracin zinc ointment is then applied over the trifluridine Lesions are covered by a nonabsorbent dressing Medication is applied every 8 hours
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 |
|---|---|---|---|
| 11147 | REGISTRY | DAIDS ES Registry Number | None |