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Trial NCT00000705

Resource URI: http://static.linkedct.org/resource/trials/NCT00000705
linkedct:brief_title Safety and Effectiveness of Azidothymidine (AZT) in HIV-Positive Patients With Hemophilia
linkedct:condition <http://static.linkedct.org/resource/condition/5486>
linkedct:condition <http://static.linkedct.org/resource/condition/5816>
linkedct:criteria Inclusion Criteria You may be eligible for this study if you: - Are HIV-positive. - Have a bleeding disorder such as hemophilia A or B, a lack of factor VIII (a blood clotting factor), or severe von Willebrand's disease. - Will be available for follow-up for at least a year. - Are at least 12 years old (consent of parent or guardian required if under 18). - Are willing to use an effective method of birth control during the study. Exclusion Criteria You will not be eligible for this study if you: - Have a life-threatening opportunistic (AIDS-related) infection or AIDS-related symptoms. - Have taken certain drugs within 30 days prior to study entry including chemotherapy and interferon. - Are taking acetaminophen or drugs containing acetaminophen. - Are pregnant or breast-feeding.
linkedct:description There is a clear risk for development of AIDS in hemophilic patients. AZT administration has been shown to inhibit HIV replication in vitro. Patients taking AZT have experienced fewer opportunistic infections and improvements in measures of immunity. The most common laboratory abnormalities observed with AZT are hematologic. However, the clinical and laboratory toxicity of AZT remains poorly understood in hemophiliacs. Hepatitis and liver dysfunction are more common in this population compared to other groups at risk for HIV infection. Because AZT is largely metabolized in the liver, drug pharmacokinetics needs to be evaluated in this patient population. Both hemophiliacs and non-hemophiliacs take AZT for a period of 12 weeks. The first dose is administered intravenously. AZT is then given orally every 4 hours while awake (5 doses per day). Patients are evaluated by physical examinations and laboratory assessments. These include HIV culture of blood and leukocyte counts, lymphocyte counts, and lymphocyte subsets measured at study entry and every 4 weeks thereafter. Patients are hospitalized for pharmacokinetic studies at study entry and at Weeks 6 and 12. Each of these studies involves both intravenous and oral administration within 48 hours of one another. Blood is sampled at 0, 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours after each administration and urine is collected every 2 hours for 12 hours.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age N/A
linkedct:eligibility_minimum_age 12 Years
linkedct:enrollment 24 (xsd:int)
linkedct:firstreceived_date November 2, 1999
linkedct:id NCT00000705
rdfs:label Trial NCT00000705
linkedct:lastchanged_date July 11, 2008
linkedct:lead_sponsor_agency National Institute of Allergy and Infectious Diseases (NIAID)
linkedct:location <http://static.linkedct.org/resource/location/156869>
linkedct:location <http://static.linkedct.org/resource/location/157323>
linkedct:nct_id NCT00000705
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title A Phase I Trial to Evaluate Azidothymidine (AZT) in the Treatment of HIV Infections in Patients With Hemophilia
linkedct:org_study_id ACTG 017
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/49597>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000705>
linkedct:phase Phase 1
linkedct:reference <http://static.linkedct.org/resource/reference/2501>
linkedct:reference <http://static.linkedct.org/resource/reference/2778>
linkedct:reference <http://static.linkedct.org/resource/reference/38853>
linkedct:reference <http://static.linkedct.org/resource/reference/39703>
linkedct:source National Institute of Allergy and Infectious Diseases (NIAID)
linkedct:study_design Treatment, Open Label, Pharmacokinetics Study
linkedct:study_type Interventional
linkedct:summary The purpose of this study is to see if giving azidothymidine (AZT) to HIV-positive patients with hemophilia is safe and if it is effective in lowering HIV levels and boosting the immune system. HIV infects and inactivates certain blood cells that are part of the body's immune system. The damage to the body's immune system can result in unusual infections and/or unusual forms of cancer. A large percentage of hemophiliacs are HIV-positive and there is a clear risk for the development of AIDS in these patients. AZT may be effective in lowering HIV levels and boosting the immune system but its side effects are not understood in these patients.
rdf:type linkedct:trials
linkedct:verification_date October 1991