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Trial NCT00000704

Resource URI: http://static.linkedct.org/resource/trials/NCT00000704
PropertyValue
linkedct:brief_title A Multicenter Dose Ranging Clinical Trial of 2',3'-Dideoxycytidine in the Treatment of Patients With AIDS and Advanced ARC.
linkedct:condition <http://static.linkedct.org/resource/condition/5486>
linkedct:criteria Inclusion Criteria Concurrent Medication: Allowed: - Aspirin, acetaminophen, and nonsteroidal anti-inflammatory agents. - Acute therapy (7 days) with oral acyclovir. - Acute therapy with ketoconazole. Exclusion Criteria Co-existing Condition: Patients with the following are excluded: - Negative antigen test within 2 weeks of starting therapy. - Significant malabsorption (> 10 percent weight loss within past 3 months with serum carotene < 75 IU/ml or vitamin A < 75 IU/ml). - Significant cardiac, liver, or neurologic disease. - For group A: - Opportunistic infection or malignancy fulfilling definition of AIDS, or with concurrent neoplasm other than basal cell carcinoma of the skin or in situ carcinoma of the cervix. - For group B: - Active opportunistic infection, symptomatic visceral Kaposi's sarcoma (KS), progression of KS within the month prior to study entry, or with concurrent neoplasms other than KS, basal cell carcinoma of the skin, or in situ carcinoma of the cervix. Concurrent Medication: Excluded: - Acyclovir therapy. - Chemoprophylaxis for Pneumocystis carinii pneumonia. - Other antiretroviral agents, biologic modifiers, or systemic corticosteroids. - Other experimental medications, sedatives, and barbiturates. - Group B: - Therapy and/or prophylaxis for AIDS-defining opportunistic infection, antineoplastic therapy. Concurrent Treatment: Excluded: - Transfusion dependency (requiring 2 units of blood more than once per month). Patients with history of idiopathic thrombocytopenia purpura are excluded. Prior Medication: Excluded within 30 days of study entry: - Biologic modifiers or corticosteroids. - Excluded within 90 days of study entry: - Antiretroviral agents. Prior Treatment: Excluded within 2 weeks of study entry: - Transfusion. Inclusion criteria are: - Consistently positive HIV antigen as defined by Abbott HIV antigen test. This demonstration will be seen on two occasions, each separated by at least 72 hours, the last of which must be within 2 weeks of starting therapy. - HIV antigen titer must be = or > 100 pg. - Positive antibody to HIV confirmed by any federally licensed enzyme-linked immunosorbent assay (ELISA) test kit. The following conditions are allowed: - Basal cell carcinoma of the skin or in situ carcinoma of the cervix. Active substance abuse.
linkedct:description Recent studies show that a certain group of drugs (dideoxynucleosides) are effective in treating patients with HIV infection. ddC is a dideoxynucleoside and test tube studies show that it may be valuable in treating AIDS patients. ddC has been shown to be well tolerated in certain patients with AIDS. A range of doses of ddC is given to patients with AIDS and ARC. Eight patients with AIDS and eight patients with ARC are given ddC at the lowest level for 12 weeks. Patients who respond with a rise in their number of T4 cells or with a fall in HIV antigen in their serum (the fluid portion of the blood) are continued at that dose for an additional 12 weeks. Patients who do not respond at a given dose level (no rise in T4 or fall in serum HIV antigen) stop treatment at 12 weeks. All patients are followed off therapy for 4 weeks. As each dose level is found to be well tolerated for 10 weeks in five of the eight patients in each group, additional patients will be entered at higher dose levels until eight AIDS and eight ARC patients are receiving the drug at a given level.
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 64 (xsd:int)
linkedct:firstreceived_date November 2, 1999
linkedct:id NCT00000704
rdfs:label Trial NCT00000704
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/147425>
linkedct:location <http://static.linkedct.org/resource/location/148178>
linkedct:location <http://static.linkedct.org/resource/location/173756>
linkedct:location <http://static.linkedct.org/resource/location/213506>
linkedct:location <http://static.linkedct.org/resource/location/216779>
linkedct:nct_id NCT00000704
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title A Multicenter Dose Ranging Clinical Trial of 2',3'-Dideoxycytidine in the Treatment of Patients With AIDS and Advanced ARC.
linkedct:org_study_id ACTG 012
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/40243>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000704>
linkedct:phase Phase 1
linkedct:reference <http://static.linkedct.org/resource/reference/38304>
linkedct:reference <http://static.linkedct.org/resource/reference/39289>
linkedct:source National Institute of Allergy and Infectious Diseases (NIAID)
linkedct:study_design Treatment, Open Label
linkedct:study_type Interventional
linkedct:summary To evaluate the long-term safety and effectiveness of the drug 2',3'-dideoxycytidine ( zalcitabine; ddC ) in treating patients with AIDS or advanced AIDS related complex ( ARC ). Recent studies show that a certain group of drugs (dideoxynucleosides) are effective in treating patients with HIV infection. ddC is a dideoxynucleoside and test tube studies show that it may be valuable in treating AIDS patients. ddC has been shown to be well tolerated in certain patients with AIDS.
rdf:type linkedct:trials
linkedct:verification_date August 1991