Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000629
Status:
COMPLETED
Last Update Posted:
2008-07-30
First Post:
1999-11-02
Brief Title:
The Effects of Valproic Acid on Zidovudine Glucuronidation and Pharmacokinetics in HIV-Infected Patients
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
The Effects of Valproic Acid on Zidovudine Glucuronidation and Pharmacokinetics in HIV-Infected Patients
Status:
COMPLETED
Status Verified Date:
2003-10
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:
Primary objective To study the pharmacokinetic interaction between zidovudine AZT and valproic acid in asymptomatic HIV-infected patients characterizing AZTs oral bioavailability plasma elimination half-time plasma levels and urinary excretion of AZT 5-O-glucuronide GAZT and 3-amino-3-deoxythymidine AMT Secondary objective To establish the safety of short-term administration of AZT and valproic acid in combination with regard to hematologic parameters and liver function in asymptomatic HIV-infected patients
Preliminary studies using human liver tissue have shown that valproic acid inhibits the metabolic inactivation of zidovudine AZT which may prolong the plasma half-life of AZT and thus prolong the duration of the drugs effects in the body
Preliminary studies using human liver tissue have shown that valproic acid inhibits the metabolic inactivation of zidovudine AZT which may prolong the plasma half-life of AZT and thus prolong the duration of the drugs effects in the body
Detailed Description:
Preliminary studies using human liver tissue have shown that valproic acid inhibits the metabolic inactivation of zidovudine AZT which may prolong the plasma half-life of AZT and thus prolong the duration of the drugs effects in the body
Six asymptomatic HIV-infected patients are treated with AZT orally every 8 hours on days 1 through 4 then with a single dose on day 5 after 8 hours of fasting followed by pharmacokinetic sampling On days 6 through 9 patients receive AZT orally every 8 hours in combination with valproic acid lowest dose in the first 5 patients and a higher dose in patients 6 and 7 orally every 8 hours On day 10 AZT and 1 of the 2 doses of valproic acid are given orally as single doses followed by pharmacokinetic sampling AZT is continued alone orally every 8 hours on days 11 through 14 then resumed at the patients usual dose beginning on day 15 Per 030992 amendment dosing schedule may be modified slightly to accommodate patients with scheduling conflicts
Six asymptomatic HIV-infected patients are treated with AZT orally every 8 hours on days 1 through 4 then with a single dose on day 5 after 8 hours of fasting followed by pharmacokinetic sampling On days 6 through 9 patients receive AZT orally every 8 hours in combination with valproic acid lowest dose in the first 5 patients and a higher dose in patients 6 and 7 orally every 8 hours On day 10 AZT and 1 of the 2 doses of valproic acid are given orally as single doses followed by pharmacokinetic sampling AZT is continued alone orally every 8 hours on days 11 through 14 then resumed at the patients usual dose beginning on day 15 Per 030992 amendment dosing schedule may be modified slightly to accommodate patients with scheduling conflicts
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?: