Home | All trials

[RDF data]
Trial NCT00000629

Resource URI: http://static.linkedct.org/resource/trials/NCT00000629
PropertyValue
linkedct:brief_title The Effects of Valproic Acid on Zidovudine Glucuronidation and Pharmacokinetics in HIV-Infected Patients.
linkedct:condition <http://static.linkedct.org/resource/condition/5486>
linkedct: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.
linkedct: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 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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Male
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 50 Years
linkedct:eligibility_minimum_age 18 Years
linkedct:enrollment 6 (xsd:int)
linkedct:firstreceived_date November 2, 1999
linkedct:id NCT00000629
rdfs:label Trial NCT00000629
linkedct:lastchanged_date July 29, 2008
linkedct:lead_sponsor_agency National Institute of Allergy and Infectious Diseases (NIAID)
linkedct:location <http://static.linkedct.org/resource/location/197414>
linkedct:nct_id NCT00000629
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title The Effects of Valproic Acid on Zidovudine Glucuronidation and Pharmacokinetics in HIV-Infected Patients.
linkedct:org_study_id ACTG 191
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/34969>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000629>
linkedct:phase Phase 1
linkedct:reference <http://static.linkedct.org/resource/reference/2156>
linkedct:reference <http://static.linkedct.org/resource/reference/46750>
linkedct:source National Institute of Allergy and Infectious Diseases (NIAID)
linkedct:study_design Treatment, Open Label, Pharmacokinetics Study
linkedct:study_type Interventional
linkedct: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.
rdf:type linkedct:trials
linkedct:verification_date October 2003