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Trial NCT00000628

Resource URI: http://static.linkedct.org/resource/trials/NCT00000628
PropertyValue
linkedct:brief_title A Pharmacokinetic Study of L-697,661 Alone and in Combination With Zidovudine
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/5445>
linkedct:condition <http://static.linkedct.org/resource/condition/5486>
linkedct:criteria Inclusion Criteria Patients must have: - HIV infection. Prior Medication: Included: - Patients in Part 1 must have received no previous zidovudine (AZT) or a stable dose of at least 500 mg/day without evidence of toxicity. - Patients in Part 2 must have received no previous AZT or = or > 300 mg/day for < 6 consecutive weeks within 1 year prior to study entry. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: - Acute HIV-related opportunistic infection requiring ongoing treatment. - Diarrhea defined as 3 or more liquid stools/day for one week. - Wilson's or Gilbert's disease, porphyria, or other chronic or acute hepatic disease. - Potentially life-threatening allergic reactions to any of the components of zidovudine. - Acute or chronic medical conditions that in the opinion of the investigator would place patient at risk by participation in this study. Concurrent Medication: Excluded: - Systemic bronchodilators, acetaminophen, aspirin. Prior Medication: Excluded: - Didanosine (ddI) or dideoxycytidine (ddC) within 14 days prior to entry. - Immune modulators or investigational drugs within 30 days prior to entry. - Drugs known to induce hepatocellular enzymes, such as phenobarbital, phenytoin, warfarin, ketoconazole, and oral contraceptives, within 30 days prior to entry. Patients in Part 2 only: Excluded: - Zidovudine within 4 weeks prior to receiving first dose of study drug. Risk Behavior: Excluded: - Patients who the investigator feels would not comply with study requirements. Patients may not have the following prior conditions: - Acute or chronic medical conditions that in the opinion of the investigator would place patient at risk by participation in this study. - Potentially life-threatening allergic reactions to any of the components of zidovudine.
linkedct:description L-697,661 is a newly identified compound that inhibits HIV replication (reproduction and growth) in cell culture. It works together with AZT against HIV. Part 1: Twelve patients are randomly assigned to one of two groups. Group 1 patients receive AZT for 7 days, followed by AZT plus L-697,661 with food for 56 days. Group 2 patients receive no drug for 7 days, followed by L-697,661 with food for 56 days. Antipyrine is administered 1 hour prior to study drug on days 8, 22, and 35. Part 2: Fifteen patients receive L-697,661 with food, for 8 weeks. Therapy with L-697,661 may be extended beyond 8 weeks for up to 24 weeks.
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 27 (xsd:int)
linkedct:firstreceived_date November 2, 1999
linkedct:id NCT00000628
rdfs:label Trial NCT00000628
linkedct:lastchanged_date July 29, 2008
linkedct:lead_sponsor_agency Merck
linkedct:location <http://static.linkedct.org/resource/location/192501>
linkedct:location <http://static.linkedct.org/resource/location/192729>
linkedct:location <http://static.linkedct.org/resource/location/205891>
linkedct:location <http://static.linkedct.org/resource/location/216072>
linkedct:location <http://static.linkedct.org/resource/location/220319>
linkedct:nct_id NCT00000628
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title A Pharmacokinetic Study of L-697,661 Alone and in Combination With Zidovudine
linkedct:org_study_id ACTG 184
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/52159>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/3038>
foaf:page <http://clinicaltrials.gov/show/NCT00000628>
linkedct:phase Phase 1
linkedct:reference <http://static.linkedct.org/resource/reference/2019>
linkedct:reference <http://static.linkedct.org/resource/reference/50056>
linkedct:reference <http://static.linkedct.org/resource/reference/623>
linkedct:secondary_id Merck Protocol 020-00
linkedct:source National Institute of Allergy and Infectious Diseases (NIAID)
linkedct:study_design Treatment, Parallel Assignment, Pharmacokinetics Study
linkedct:study_type Interventional
linkedct:summary Part 1: To study the potential safety and pharmacokinetic (blood level) effects of zidovudine (AZT) on L-697,661; to obtain additional pharmacokinetic information in humans with L-697,661; to study the effect of L-697,661 on hepatic enzyme induction. Part 2: To begin a study of the antiviral activity of L-697,661. L-697,661 is a newly identified compound that inhibits HIV replication (reproduction and growth) in cell culture. It works together with AZT against HIV.
rdf:type linkedct:trials
linkedct:verification_date October 1994