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Trial NCT00000827

Resource URI: http://static.linkedct.org/resource/trials/NCT00000827
PropertyValue
linkedct:brief_title A Phase I/II Study of Hyperimmune IVIG in Slowing Progression of Disease in HIV-Infected Children
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/5759>
linkedct:condition <http://static.linkedct.org/resource/condition/5486>
linkedct:criteria Inclusion Criteria Concurrent Medication: Required: - PCP prophylaxis according to CDC guidelines. Allowed: - Varicella-zoster immunoglobulin. - Hepatitis B immunoglobulin. - Prophylactic therapies not involving immunoglobulin. Patients must have: - HIV infection. - CD4 count > 200 cells/mm3 (ages 2-5 years) or > 100 cells/mm3 (age > 5 years). - Antiretroviral therapy for at least 6 months, with no change in regimen for at least 3 months prior to study entry. - Plasma ICD p24 >= 70 pg/ml that is stable or increasing prior to study entry. - Life expectancy of at least 6 months. Prior Medication: Required: - Antiretroviral therapy for at least 6 months, with stable dose for at least 3 months. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Severe diarrhea, nephrotic syndrome, or other protein-losing state that requires large doses of IVIG. - Any other condition requiring dosing with IVIG (e.g., ITP, hypogammaglobulinemia). - Acute illness with temperature >= 100 F and/or with IV antibiotics. - Grade 3 or worse clinical toxicities. - Unable to tolerate IV infusions at a minimum rate of 0.02 ml/kg/min. - Concomitant participation in an experimental antiretroviral or HIV vaccine trial. Concurrent Medication: Excluded: - IVIG. - Chemotherapy for an active malignancy. - MMR or rubella vaccinations. - Intramuscular immunoglobulin. Patients with the following prior condition are excluded: - History of severe reaction to IVIG. Prior Medication: Excluded: - IVIG within the past 60 days. - Chemotherapy for an active malignancy within the past year. - MMR or rubella vaccinations within the past 6 months. - Intramuscular immunoglobulin within the past 60 days. Ongoing drug or alcohol abuse.
linkedct:description Passive antibody therapy has been used with limited success in treating advanced HIV disease in adults. HIVIG is manufactured from HIV antibody-rich plasma taken from asymptomatic donors. It is hypothesized that HIVIG will decrease the viral burden of moderately advanced HIV-positive children. Children are randomized to receive HIVIG every 4 weeks for 6 months at one of three dose levels, then are followed for 3 months after the final infusion.
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 12 Years
linkedct:eligibility_minimum_age 2 Years
linkedct:enrollment 45 (xsd:int)
linkedct:firstreceived_date November 2, 1999
linkedct:id NCT00000827
rdfs:label Trial NCT00000827
linkedct:lastchanged_date June 23, 2005
linkedct:lead_sponsor_agency National Institute of Allergy and Infectious Diseases (NIAID)
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linkedct:nct_id NCT00000827
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title A Phase I/II Study of Hyperimmune IVIG in Slowing Progression of Disease in HIV-Infected Children
linkedct:org_study_id ACTG 273
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/56352>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/60807>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000827>
linkedct:phase Phase 1
linkedct:reference <http://static.linkedct.org/resource/reference/6347>
linkedct:source National Institute of Allergy and Infectious Diseases (NIAID)
linkedct:study_design Treatment, Pharmacokinetics Study
linkedct:study_type Interventional
linkedct:summary To evaluate the safety, tolerance, pharmacokinetics, and antiviral activity of human anti-HIV immune serum globulin ( HIVIG ) at three dosage levels in HIV-infected children. Passive antibody therapy has been used with limited success in treating advanced HIV disease in adults. HIVIG is manufactured from HIV antibody-rich plasma taken from asymptomatic donors. It is hypothesized that HIVIG will decrease the viral burden of moderately advanced HIV-positive children.
rdf:type linkedct:trials
linkedct:verification_date January 2003