Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001054
Status:
WITHDRAWN
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
The Safety and Effectiveness of Valacyclovir HCl in the Treatment of Herpes Simplex or VaricellaZoster Infections in HIV-1 Infected Children
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase I Trial to Evaluate the Pharmacokinetics Safety and Tolerance of Valacyclovir HCl in HIV-1 Infected Children With Herpes Simplex Infections or VaricellaZoster Infections
Status:
WITHDRAWN
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 obtain tolerance safety and pharmacokinetic data for oral valacyclovir hydrochloride 256U87 in HIV-1 infected children with herpes simplex virus infections cold sores andor varicella zoster virus infections chicken pox shingles
Varicella and zoster are common problems in HIV-infected children It is believed that chronic oral therapy with acyclovir may result in subtherapeutic concentrations of acyclovir resulting in resistance to that drug Valacyclovir hydrochloride which converts to acyclovir in the body increases acyclovir bioavailability by 3-5 fold
Varicella and zoster are common problems in HIV-infected children It is believed that chronic oral therapy with acyclovir may result in subtherapeutic concentrations of acyclovir resulting in resistance to that drug Valacyclovir hydrochloride which converts to acyclovir in the body increases acyclovir bioavailability by 3-5 fold
Detailed Description:
Varicella and zoster are common problems in HIV-infected children It is believed that chronic oral therapy with acyclovir may result in subtherapeutic concentrations of acyclovir resulting in resistance to that drug Valacyclovir hydrochloride which converts to acyclovir in the body increases acyclovir bioavailability by 3-5 fold
In the first cohort patients with stable herpes simplex virus receive valacyclovir hydrochloride at 1 of 2 doses depending on body surface area BSA for 10 days If acceptable safety is seen at this dose level a second cohort of patients with stable herpes simplex virus receive a higher dose depending on BSA for 10 days A third cohort of patients with varicella or zoster receive a selected dose based on results from the previous cohorts
In the first cohort patients with stable herpes simplex virus receive valacyclovir hydrochloride at 1 of 2 doses depending on body surface area BSA for 10 days If acceptable safety is seen at this dose level a second cohort of patients with stable herpes simplex virus receive a higher dose depending on BSA for 10 days A third cohort of patients with varicella or zoster receive a selected dose based on results from the previous cohorts
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 |
|---|---|---|---|
| 11230 | REGISTRY | DAIDS-ES | None |