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The Effects of Valproic Acid on Zidovudine Glucuronidation and Pharmacokinetics in HIV-Infected Patients. Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about The Effects of Valproic Acid on Zidovudine Glucuronidation and Pharmacokinetics in HIV-Infected Patients. conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. The Effects of Valproic Acid on Zidovudine Glucuronidation and Pharmacokinetics in HIV-Infected Patients. Clinical research trials and The Effects of Valproic Acid on Zidovudine Glucuronidation and Pharmacokinetics in HIV-Infected Patients. health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like The Effects of Valproic Acid on Zidovudine Glucuronidation and Pharmacokinetics in HIV-Infected Patients.. The Effects of Valproic Acid on Zidovudine Glucuronidation and Pharmacokinetics in HIV-Infected Patients. Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a The Effects of Valproic Acid on Zidovudine Glucuronidation and Pharmacokinetics in HIV-Infected Patients. clinical trial. Subjects frequently get the best healthcare possible for their The Effects of Valproic Acid on Zidovudine Glucuronidation and Pharmacokinetics in HIV-Infected Patients. condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "T" Clinical Trials Conditions > The Effects of Valproic Acid on Zidovudine Glucuronidation and Pharmacokinetics in HIV-Infected Patients.  The Effects of Valproic Acid on Zidovudine Glucuronidation and Pharmacokinetics in HIV-Infected Patients.
The Effects of Valproic Acid on Zidovudine Glucuronidation and Pharmacokinetics in HIV-Infected Patients.
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Open Label, Pharmacokinetics Study
Minimum Age/Maximum Age: 18 Years/50 Years
Genders: Male
Protocol Entry 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.
Total Enrollment: 6
Location and Contact Information:
Overall Study Official:
LertoraJJL, Study Chair,
Tulane Univ Med School
New Orleans, Louisiana, 701122699
United States
Additional Information:
Study ID Numbers: ACTG 191;
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000629
Other Hiv Infections Studies:
1. Evaluation of the Safety of and Immune Response to an HIV Vaccine in Healthy Adults
2. A Study of Cidofovir in HIV-Infected Children with Cytomegalovirus (CMV) Disease
3. A Phase I Study of the Safety of Proleukin (aldesleukin) in Combination with Ganciclovir and Antiretroviral Therapy in HIV Seropositive Patients With Cytomegalovirus (CMV) Retinitis
4. Preventing Frequent Sinus Infections in HIV-Infected Patients
5. A Study on the Safety and Effectiveness of Adefovir Dipivoxil in Combination with Anti-HIV Therapy (HAART) in HIV-Positive Patients
Related Studies:
Other HIV Infections Clinical Trials
Other Louisiana Clinical Trials
Other New Orleans Clinical Trials
The Effects of Valproic Acid on Zidovudine Glucuronidation and Pharmacokinetics in HIV-Infected Patients.
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