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Trial NCT00000664

Resource URI: http://static.linkedct.org/resource/trials/NCT00000664
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linkedct:brief_title Safety and Efficacy of Polyethylene Glycolated IL-2 (PEG IL-2) Plus Zidovudine in HIV Positive, Asymptomatic and Symptomatic Individuals
linkedct:condition <http://static.linkedct.org/resource/condition/5486>
linkedct:criteria Inclusion Criteria Concurrent Medication: Allowed: - Prophylactic pentamidine for Pneumocystis carinii pneumonia (PCP). - Topical steroids. Patients must: - Be HIV positive. Fit one of the zidovudine use groups listed in Disease Status. Be able to give informed consent. Allowed: - Basal cell carcinoma of the skin, in situ carcinoma of the cervix, Kaposi's sarcoma. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: - Major organ allograft. - Significant cardiac disease or central nervous system lesions. - Known previous intolerance to zidovudine (AZT) at 500 mg/day. - Active opportunistic infections. Score of > 0.5 on the ACTG AIDS dementia complex staging test. Any focal abnormality on neurologic exam. Concurrent Medication: Excluded: - Chemotherapy, hormonal therapy, or other immunotherapy. - Other investigational drugs, agents, or devices. - Beta-blockers. - Steroids other than topical. - Antihypertensive medication other than diuretics. Concurrent Treatment: Excluded: - Radiation therapy. Patients with the following are excluded: - History of seizures. Concurrent neoplasms not specifically allowed. - Concomitant conditions listed in Exclusion Co-existing Conditions. Prior Medication: Excluded within 30 days prior to study entry: - Anti-HIV medication other than zidovudine (AZT). - Immunomodulators. - Systemic steroids. - Interferons. - Interleukins. - Other chemotherapy. Prior Treatment: Excluded within 30 days prior to study entry: - Radiation therapy. Excluded within 4 weeks prior to study entry: - Groups B, C, D - Transfusions. Active substance abuse.
linkedct:description Recent research has focused on enhancing cell-mediated immunity and reducing or eliminating viral replication (reproduction and growth). A main thrust of current treatment is the combination of antiviral drugs that may be more effective when combined than when each is used alone. Four groups are studied for a period of at least 25 weeks. Patients are observed for a minimum of 6 hours after infusion of PEG IL2. The 4 groups of patients are: Group A - asymptomatic with T4 count > 400 cells/mm3 (7 patients); Group B - asymptomatic with T4 count between 200 and 400 cells/mm3 (7 patients); Group C - asymptomatic with T4 count < 200 cells/mm3 (5 patients); Group D - diagnosed as having AIDS related complex (ARC) or AIDS (7 patients). All patients receive AZT. After a minimum 2-week period of AZT, patients receive an infusion of PEG IL-2 at 3 consecutive weekly intervals, followed by a 3-week period of AZT alone. This cycle (3 weeks of AZT and PEG IL-2 followed by 3 weeks of AZT alone) is repeated a total of three times (for a total of 18 weeks) followed by 8 weeks of AZT alone. PER AMENDMENT: Ten patients may qualify for one of two groups: Group 1 - T4 count 200 - 400 cells/mm3 and meet all criteria established for Group B of the original protocol; Group 2 - T4 count < 200 cells/mm3 and meet all criteria established for Groups C and D of original protocol. Patients will receive an amended schedule of PEG IL2 IV every other week for eight doses, with dose escalation every other week for eight weeks permitted only in Group 2 patients who failed to show a 20 percent rise in T4 count at week 9 and who suffered no CNS or other adverse events at the lower dose. PER ADDITIONAL AMENDMENT: Up to 10 additional patients may be treated at each dose of PEG IL2 on the biweekly schedule. Patients who respond to treatment on the biweekly schedule are eligible for an additional 9 weeks at their current dose.
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 26 (xsd:int)
linkedct:firstreceived_date November 2, 1999
linkedct:id NCT00000664
rdfs:label Trial NCT00000664
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/216779>
linkedct:nct_id NCT00000664
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Safety and Efficacy of Polyethylene Glycolated IL-2 (PEG IL-2) Plus Zidovudine in HIV Positive, Asymptomatic and Symptomatic Individuals
linkedct:org_study_id ACTG 141
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/24257>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/57616>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000664>
linkedct:phase Phase 1
linkedct:reference <http://static.linkedct.org/resource/reference/47433>
linkedct:secondary_id CS-PG89-36
linkedct:secondary_id FDA 70A
linkedct:source National Institute of Allergy and Infectious Diseases (NIAID)
linkedct:study_design Treatment, Parallel Assignment
linkedct:study_type Interventional
linkedct:summary To determine the safety of polyethylene glycolated IL-2 (PEG IL2) administered weekly or biweekly (per amendment) in a setting of oral zidovudine (AZT). To determine the effect of PEG IL2 in combination with AZT on parameters assessing the immune system as well as HIV virus and antibody titers. To evaluate a chronic dosing study phase offered to patients who complete the initial 25-week regimen. Recent research has focused on enhancing cell-mediated immunity and reducing or eliminating viral replication (reproduction and growth). A main thrust of current treatment is the combination of antiviral drugs that may be more effective when combined than when each is used alone.
rdf:type linkedct:trials
linkedct:verification_date December 1994