HIV Infections Clinical Trial
Official title:
The Effects of Valproic Acid on Zidovudine Glucuronidation and Pharmacokinetics in HIV-Infected Patients.
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.
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.
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 patient's usual dose
beginning on day 15. Per 03/09/92 amendment, dosing schedule may be modified slightly to
accommodate patients with scheduling conflicts.
;
Endpoint Classification: Pharmacokinetics Study, Masking: Open Label, Primary Purpose: Treatment
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