Expired Study
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New Orleans, Louisiana 70112


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria Concurrent Medication: Allowed: Vitamins if already being taken prior to start of therapy. Patients must have: - Asymptomatic HIV infection. - CD4 count between 300 and 650. Prior Medication: Required: - AZT at doses between 500 and 1200 mg/day for at least 6 weeks prior to enrollment. Allowed: - Aspirin, Tylenol, or ibuprofen up to 48 hours prior to start of therapy. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Positive Hepatitis B surface antigen or clinical evidence of chronic active hepatitis of any type. - Signs or symptoms of HIV infection including oral candidiasis, history of multidermatomal zoster, unexplained weight loss in excess of 10 percent body weight in the past 6 months, chronic diarrhea, or history of AIDS-defining opportunistic infections. Concurrent Medication: Excluded: - Concomitant medications (other than AZT) for the 14 days prior to start of therapy. Patients with the following prior conditions are excluded: - History of AZT intolerance including hematologic, hepatic, and/or neurologic toxicity. - History of seizures. - History of any antiepileptics within the past 10 years. - History of abnormal bleeding or intrinsic or extrinsic coagulopathy. - Signs or symptoms of HIV infection including oral candidiasis, history of multidermatomal zoster, unexplained weight loss in excess of 10 percent body weight in the past 6 months, chronic diarrhea, or history of AIDS-defining opportunistic infections. Prior Medication: Excluded: - Antiepileptics within the past 10 years. - Prior valproic acid. - Concomitant medications (other than AZT) within 14 days of enrollment.


NCT ID:

NCT00000629


Primary Contact:

Study Chair
Lertora JJL


Backup Contact:

N/A


Location Contact:

New Orleans, Louisiana 70112
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 17, 2017

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