Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000985
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
Comparison of Foscarnet Versus Vidarabine in the Treatment of Herpes Infection in Patients With AIDS Who Have Not Had Success With Acyclovir
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 Infection in Patients With the Acquired Immunodeficiency Syndrome A Randomized Multicenter Study of Foscarnet Versus Vidarabine
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 compare the safety and effectiveness of foscarnet and vidarabine treatments for AIDS patients who have herpes simplex virus infections that are resistant to standard treatment with acyclovir
Foscarnet is a drug that inhibits viruses and has been shown to be effective against infection with Cytomegalovirus and also against infection with the Herpes simplex virus in several patients with AIDS Vidarabine has been shown to have activity against the Herpes simplex virus in patients who do not have AIDS but it has not been studied in patients who do have AIDS This study compares foscarnet and vidarabine treatments for AIDS patients who have herpes simplex infection that has not responded to therapy with acyclovir in the hope that one of these two drugs will help to stop further progression of the herpes simplex infection and may have fewer side effects
Foscarnet is a drug that inhibits viruses and has been shown to be effective against infection with Cytomegalovirus and also against infection with the Herpes simplex virus in several patients with AIDS Vidarabine has been shown to have activity against the Herpes simplex virus in patients who do not have AIDS but it has not been studied in patients who do have AIDS This study compares foscarnet and vidarabine treatments for AIDS patients who have herpes simplex infection that has not responded to therapy with acyclovir in the hope that one of these two drugs will help to stop further progression of the herpes simplex infection and may have fewer side effects
Detailed Description:
Foscarnet is a drug that inhibits viruses and has been shown to be effective against infection with Cytomegalovirus and also against infection with the Herpes simplex virus in several patients with AIDS Vidarabine has been shown to have activity against the Herpes simplex virus in patients who do not have AIDS but it has not been studied in patients who do have AIDS This study compares foscarnet and vidarabine treatments for AIDS patients who have herpes simplex infection that has not responded to therapy with acyclovir in the hope that one of these two drugs will help to stop further progression of the herpes simplex infection and may have fewer side effects
Following evaluation studies patients receive at least 10 days of intravenous IV therapy with acyclovir During this therapy patients have two serum concentration levels of acyclovir drawn to make sure there are adequate levels of medication in their blood If skin lesions do not heal after a total of 10 days of therapy with acyclovir lesions are swabbed for viral culture to test the susceptibility of the virus to therapy with acyclovir foscarnet and vidarabine If the test confirms that the herpes lesions are resistant to acyclovir patients may choose to participate in the next phase of the study Following additional evaluation studies patients are randomized to one of two groups each of which receives 10-21 days of IV treatment with one of the two alternative medications foscarnet or vidarabine Foscarnet is given by IV infusion every 8 hours and each infusion lasts 1 hour Vidarabine is given by IV infusion once a day and each infusion lasts 12 hours While receiving therapy with either foscarnet or vidarabine blood tests are done every 3 days for routine lab tests and once a week to determine foscarnet or vidarabine blood levels Skin lesions are cultured for herpes virus every 5 days At the end of 10 days of therapy improvement is evaluated and the patients can continue to receive therapy if indicated There is a provision for cross-over treatment if patients show a poor response
Following evaluation studies patients receive at least 10 days of intravenous IV therapy with acyclovir During this therapy patients have two serum concentration levels of acyclovir drawn to make sure there are adequate levels of medication in their blood If skin lesions do not heal after a total of 10 days of therapy with acyclovir lesions are swabbed for viral culture to test the susceptibility of the virus to therapy with acyclovir foscarnet and vidarabine If the test confirms that the herpes lesions are resistant to acyclovir patients may choose to participate in the next phase of the study Following additional evaluation studies patients are randomized to one of two groups each of which receives 10-21 days of IV treatment with one of the two alternative medications foscarnet or vidarabine Foscarnet is given by IV infusion every 8 hours and each infusion lasts 1 hour Vidarabine is given by IV infusion once a day and each infusion lasts 12 hours While receiving therapy with either foscarnet or vidarabine blood tests are done every 3 days for routine lab tests and once a week to determine foscarnet or vidarabine blood levels Skin lesions are cultured for herpes virus every 5 days At the end of 10 days of therapy improvement is evaluated and the patients can continue to receive therapy if indicated There is a provision for cross-over treatment if patients show a poor response
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 |
|---|---|---|---|
| 11070 | REGISTRY | DAIDS ES Registry Number | None |