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Trial NCT00000700

Resource URI: http://static.linkedct.org/resource/trials/NCT00000700
PropertyValue
linkedct:brief_title A Multi-Center Clinical Trial To Evaluate Azidothymidine (AZT) in the Treatment of Human Immunodeficiency Virus (HIV) Infection in Patients With AIDS Post First Episode PCP
linkedct:condition <http://static.linkedct.org/resource/condition/5486>
linkedct:criteria Inclusion Criteria Concurrent Medication: Allowed: - All concomitant medication to minimum and record. - Any approved medications can be used to treat an opportunistic infection. - Dapsone may be used for Pneumocystis carinii pneumonia (PCP). - Pyrimethamine - sulfadoxine may be used for toxoplasmosis. - Ganciclovir for cytomegalovirus may be used for maintenance only. - Prophylactic therapy for PCP. Concurrent Treatment: Allowed: - Local, limited radiation therapy to isolated Kaposi's sarcoma lesions provided total area is < 5 x 5 cm and a 6-MeV electron beam or 90 kV x-ray = or < 3000 rads total is used. Patients must have: - HIV seropositivity as confirmed by any federally licensed ELISA test kit. - Allowed: - Malignancy in past which has been in complete remission for 1 year without therapy. Exclusion Criteria Co-existing Condition: Patients with active opportunistic infections will be excluded. Concurrent Medication: Excluded: - Aspirin on a regular basis or beyond 72 hours without contacting investigator. - Cimetidine. - Flurazepam. - Indomethacin. - Ranitidine. - Probenecid. Patients with the following are excluded: - Status post-Pneumocystis carinii pneumonia with symptomatic visceral Kaposi's sarcoma (KS) or progression of KS within the month prior to study entry. - Other concurrent neoplasms other than basal cell carcinoma of the skin. - Requiring blood transfusions > once per month. Last transfusion cannot have been given within 7 days of entry. - Active substance abuse. Unwilling to sign informed consent or to be followed at medical center where enrolled for duration of study and follow-up if necessary. Prior Medication: Excluded within 2 weeks of study entry: - Treatment for acute Pneumocystis carinii pneumonia (PCP). - Excluded within 30 days of study entry: - Other antiretroviral agents, immunomodulating agents, or corticosteroids. Prior Treatment: Excluded within 30 days of study entry: - Radiation therapy or cytotoxic chemotherapy for Kaposi's sarcoma. Required: - Patients must be at least 2 weeks post- therapy status for acute Pneumocystis carinii pneumonia (PCP).
linkedct:description Previous studies have shown the effectiveness of AZT in AIDS therapy. AZT has been effective in test tube studies at varying doses. There is a need to see if lower doses result in effective therapy with less harmful side effects. Patients are assigned at random to one of two treatment programs: (1) 1 dose of AZT given orally (PO) for 6 doses per day; (2) 2 doses of AZT PO for 4 weeks followed by 1 dose PO for the remainder of the trial.
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 482 (xsd:int)
linkedct:firstreceived_date November 2, 1999
linkedct:id NCT00000700
rdfs:label Trial NCT00000700
linkedct:lastchanged_date July 31, 2008
linkedct:lead_sponsor_agency National Institute of Allergy and Infectious Diseases (NIAID)
linkedct:location <http://static.linkedct.org/resource/location/144090>
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linkedct:location <http://static.linkedct.org/resource/location/213506>
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linkedct:location <http://static.linkedct.org/resource/location/216187>
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linkedct:location <http://static.linkedct.org/resource/location/220079>
linkedct:nct_id NCT00000700
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title A Multi-Center Clinical Trial To Evaluate Azidothymidine (AZT) in the Treatment of Human Immunodeficiency Virus (HIV) Infection in Patients With AIDS Post First Episode PCP
linkedct:org_study_id ACTG 002
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/17854>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000700>
linkedct:phase Phase 3
linkedct:reference <http://static.linkedct.org/resource/reference/1193>
linkedct:reference <http://static.linkedct.org/resource/reference/31337>
linkedct:reference <http://static.linkedct.org/resource/reference/36525>
linkedct:reference <http://static.linkedct.org/resource/reference/3659>
linkedct:reference <http://static.linkedct.org/resource/reference/3687>
linkedct:reference <http://static.linkedct.org/resource/reference/37738>
linkedct:reference <http://static.linkedct.org/resource/reference/38210>
linkedct:reference <http://static.linkedct.org/resource/reference/38901>
linkedct:reference <http://static.linkedct.org/resource/reference/39258>
linkedct:reference <http://static.linkedct.org/resource/reference/47435>
linkedct:source National Institute of Allergy and Infectious Diseases (NIAID)
linkedct:study_design Treatment, Parallel Assignment, Safety Study
linkedct:study_type Interventional
linkedct:summary To examine the dose of zidovudine (AZT) that was used in the first placebo-controlled study of AZT in AIDS patients as well as a lower dose of AZT in order to determine if the lower dose results in less harmful side effects while still being effective. Previous studies have shown the effectiveness of AZT in AIDS therapy. AZT has been effective in test tube studies at varying doses. There is a need to see if lower doses result in effective therapy with less harmful side effects.
rdf:type linkedct:trials
linkedct:verification_date September 2002