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A Study of Zidovudine in HIV-Infected Patients with Liver Disease Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about A Study of Zidovudine in HIV-Infected Patients with Liver Disease conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A Study of Zidovudine in HIV-Infected Patients with Liver Disease Clinical research trials and A Study of Zidovudine in HIV-Infected Patients with Liver Disease medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as A Study of Zidovudine in HIV-Infected Patients with Liver Disease. A Study of Zidovudine in HIV-Infected Patients with Liver Disease Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a A Study of Zidovudine in HIV-Infected Patients with Liver Disease clinical trial. Participants frequently get the best healthcare available for their A Study of Zidovudine in HIV-Infected Patients with Liver Disease condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Study of Zidovudine in HIV-Infected Patients with Liver Disease  A Study of Zidovudine in HIV-Infected Patients with Liver Disease
A Study of Zidovudine in HIV-Infected Patients with Liver Disease
For Condition: HIV Infections,Liver Diseases
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: To examine the pharmacokinetics (blood levels) and bioavailability of zidovudine (AZT) given to patients with HIV infection and chronic liver disease. The specific aim of the study is to provide data permitting the development of guidelines for use of AZT in patients with mild, moderate, or severe liver disease. AZT is the only antiviral agent that has been shown to be effective in patients with severe HIV infection. However, AZT is largely eliminated from the body through a biochemical reaction that takes place in the liver, and it is possible that patients with underlying liver disease may have altered AZT pharmacokinetics and may metabolize AZT differently, with the result that they are susceptible to an increased risk of serious drug toxicity. This study will examine the pharmacokinetics, elimination, and metabolism of AZT in patients with liver disease. Guidelines developed from the data will be helpful in managing AZT treatment of these HIV-infected persons and will indicate whether the dose of AZT administered should be adjusted to compensate for any changes in its bioavailability and/or pharmacokinetics.
Details: AZT is the only antiviral agent that has been shown to be effective in patients with severe HIV infection. However, AZT is largely eliminated from the body through a biochemical reaction that takes place in the liver, and it is possible that patients with underlying liver disease may have altered AZT pharmacokinetics and may metabolize AZT differently, with the result that they are susceptible to an increased risk of serious drug toxicity. This study will examine the pharmacokinetics, elimination, and metabolism of AZT in patients with liver disease. Guidelines developed from the data will be helpful in managing AZT treatment of these HIV-infected persons and will indicate whether the dose of AZT administered should be adjusted to compensate for any changes in its bioavailability and/or pharmacokinetics. Patients are assessed and stratified according to liver function and severity of liver disease. Patients receive an intravenous (IV) dose of AZT on the first day of the study, followed by an oral dose 24 hours later on the second day of the study. Patients fast for 8 hours prior to each dose and for 2 hours after each dose. Liver function tests are repeated on the first day of the study. In each patient, serial measurements of serum and urine AZT and its metabolite, 3'-azido-3'-deoxy-5'-glucuronylthymidine (GAZT), are monitored after both doses.
Eligibility:
Study Type: Interventional, Treatment, Open Label, Pharmacokinetics Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed after completion of day 2 of study: - Prior medications may be resumed. Concurrent Treatment: Allowed after completion of day 2 of study: - Cytotoxic chemotherapy or radiation therapy for Kaposi's sarcoma. The study will be divided into three groups of cooperative patients according to mild, moderate, or severe liver disease. Severity of disease will be assessed within 7 days of entry into the study according to laboratory values. Patients must have normal kidney function. No medications should be taken for 48 hours prior to entering the study. Hemophiliacs are included. Prior Medication: Allowed: - Zidovudine (AZT) if discontinued at least 48 hours prior to study entry. Exclusion Criteria Co-existing Condition: Patients will be excluded from the study if unacceptable toxicity develops or if an illness requiring concurrent treatment develops. Concurrent Medication: Excluded within 48 hours of study entry: - All medications. Medication may be resumed after completion of day 2 of the study. Concurrent Treatment: Excluded within 48 hours of study entry: - All treatments. Treatment may be resumed after completion of day 2 of the study. Patients will be excluded for the following reasons: - Presence of active opportunistic infections, with the exception of active or chronic hepatitis B virus or hepatitis D virus infection, or ongoing therapy for an opportunistic infection. - Thrombocytopenia, with platelets less than 50000 platelets/mm3. - Neutropenia, with polymorphonuclear leukocytes less than 1000 cells/mm3. - Renal insufficiency, with creatinine greater than 1.5 mg/dl. - Acute viral hepatitis within 30 days of the study. - Patients who are expected to be noncompliant or who are unwilling to sign an informed consent statement. Prior Medication: Excluded within 48 hours of study entry: - All medications. Medication may be resumed after completion of day 2 of the study. Prior Treatment: Excluded within 30 days of study entry: - Cytotoxic chemotherapy or radiation therapy for Kaposi's sarcoma. Treatment may be resumed after completion of day 2 of the study. Active drug or alcohol abuse.
Total Enrollment: 39
Location and Contact Information:
Overall Study Official:
LemonSM, Study Chair,
Univ of Massachusetts Med Ctr
Worcester, Massachusetts, 01655
United States
Boston Med Ctr
Boston, Massachusetts, 02118
United States
Milton S Hershey Med Ctr
Hershey, Pennsylvania, 170330850
United States
Univ of Washington
Seattle, Washington, 98105
United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
Additional Information:
Study ID Numbers: ACTG 062;
Study Start Date:
Record last reviewed: August 1991
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001001
Other Hiv Infections Studies:
1. Mechanisms of Inflammatory Liver Injury
2. Hepatitis B Vaccine Clinical Trial
3. Interruption of Maternal-to-Infant Transmission of Hepatitis B by Means of Hepatitis B Immune Globulin
4. Delta Hepatitis and Liver Disease in Hemophiliacs
5. Hepatic Artery Infusion of CD34+ Cells
Related Studies:
Other HIV Infections Clinical Trials
Other Pennsylvania Clinical Trials
Other Hershey Clinical Trials
A Study of Zidovudine in HIV-Infected Patients with Liver Disease
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