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Trial NCT00000661

Resource URI: http://static.linkedct.org/resource/trials/NCT00000661
PropertyValue
linkedct:brief_title The Pharmacokinetics of Zidovudine and Oxazepam Alone and in Combination in the HIV-Infected Patient
linkedct:condition <http://static.linkedct.org/resource/condition/5486>
linkedct:criteria Inclusion Criteria Concurrent Medication: Required: - Stable prescribed dosage of zidovudine (AZT), = or > 500 mg/day. Allowed: - Prophylaxis for Pneumocystis carinii pneumonia (PCP) with aerosolized pentamidine. - Erythropoietin. Patients must be: - HIV positive by ELISA and Western blot. - Currently taking a stable prescribed dosage of 500 mg/day of zidovudine (AZT). Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: - Allergy to benzodiazepines or a previously documented intolerance to zidovudine (AZT) therapy of = or < 600 mg/day. - Significant underlying medical condition that could impair continuous participation in study. - Malabsorption syndrome (3 or more loose stools a day for at least 4 weeks associated with an unintentional weight loss of at least 10 percent of body weight). Concurrent Medication: Excluded: - Oral contraceptives. - Cytotoxic chemotherapy. - Ganciclovir. - Flucytosine. - Probenecid. - Opiates. - Valproic acid. - Sulfa drugs. - Sucralfate. - Dapsone. - Rifampin. - Antacids within 2 hours of zidovudine (AZT) dose. - Isoniazid. - Ketoconazole. - Pyrimethamine. - Clindamycin. - Aspirin. - Ibuprofen. - Investigational drugs not specifically allowed. Patients with the following are excluded: - Allergy to benzodiazepines or a previously documented intolerance to zidovudine (AZT) therapy of = or < 600 mg/day. - Significant underlying medical condition that could impair continuous participation in study. - Unable to take oral medication reliably. Prior Medication: Excluded within 30 days of study entry: - Antiretroviral agents other than zidovudine (AZT).
linkedct:description Benzodiazepines (such as oxazepam) are among the most frequently prescribed class of drugs and are commonly used therapeutically for patients with chronic disease. This study is important because of the potential for toxicity resulting from a reaction between AZT and benzodiazepines and the likelihood of frequent use of the combination of these drugs in patients with HIV infection. Patients are studied to determine oral and intravenous AZT and single oral dose oxazepam pharmacokinetics. Patients then take AZT and oxazepam together to determine if interactions between the drugs occur.
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 18 Years
linkedct:enrollment 8 (xsd:int)
linkedct:firstreceived_date November 2, 1999
linkedct:id NCT00000661
rdfs:label Trial NCT00000661
linkedct:lastchanged_date August 1, 2008
linkedct:lead_sponsor_agency National Institute of Allergy and Infectious Diseases (NIAID)
linkedct:location <http://static.linkedct.org/resource/location/216636>
linkedct:nct_id NCT00000661
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title The Pharmacokinetics of Zidovudine and Oxazepam Alone and in Combination in the HIV-Infected Patient
linkedct:org_study_id ACTG 124
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/24069>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/6179>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000661>
linkedct:phase Phase 1
linkedct:reference <http://static.linkedct.org/resource/reference/2474>
linkedct:reference <http://static.linkedct.org/resource/reference/48725>
linkedct:source National Institute of Allergy and Infectious Diseases (NIAID)
linkedct:study_design Treatment, Open Label, Pharmacokinetics Study
linkedct:study_type Interventional
linkedct:summary To determine if a pharmacokinetic (blood level) interaction exists between zidovudine (AZT) and oxazepam in the HIV-infected patient. Benzodiazepines (such as oxazepam) are among the most frequently prescribed class of drugs and are commonly used therapeutically for patients with chronic disease. This study is important because of the potential for toxicity resulting from a reaction between AZT and benzodiazepines and the likelihood of frequent use of the combination of these drugs in patients with HIV infection.
rdf:type linkedct:trials
linkedct:verification_date December 1994