The Effects of Valproic Acid on Zidovudine Glucuronidation and Pharmacokinetics in HIV-Infected Patients.
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
Primary objective: To study the pharmacokinetic interaction between zidovudine (AZT) and
valproic acid in asymptomatic HIV-infected patients, characterizing AZT's 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 drug's effects in the body.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)