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Trial NCT00000872

Resource URI: http://static.linkedct.org/resource/trials/NCT00000872
PropertyValue
linkedct:brief_title Treatment With Combinations of Several Antiviral Drugs in Infants and Young Children With HIV Infection
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/2560>
linkedct:condition <http://static.linkedct.org/resource/condition/5486>
linkedct:criteria Inclusion Criteria Children may be eligible for this study if they: - Are 15 days to 2 years old. - Have consent of parent or legal guardian. - Are HIV-positive. Exclusion Criteria Children will not be eligible for this study if they: - Have certain infections which require treatment during the study. - Have received certain medications.
linkedct:description This study examines the antiretroviral activity of ZDV/3TC/NVP in vertically-infected infants and children aged 15 days up to 2 years, and ZDV/3TC/NVP/ABC in vertically-infected infants and children aged 30 days up to 2 years. This study will assess HIV-1 and CD4/CD8 T-cell kinetics, activation, and maturation. It will also test the concept that early (younger than 3 months of age) use of potent, combination antiretroviral therapy will allow the long-term control of viral replication with preservation of normal immune function. [AS PER AMENDMENT 3/11/98: This study will also examine the antiretroviral activity of ZDV/3TC/NVP/NFV in vertically infected infants and children.] This is a 2-part Phase I/II, open-label trial in HIV-infected infants. Part A assesses the triple combination of ZDV, 3TC, and NVP. Four to eight patients are enrolled in each age cohort (Cohort 1: at least 15 days, no more than 3 months; Cohort 2: over 3 months, no more than 2 years). Part B assesses the quadruple combination of ZDV, 3TC, NVP, and ABC. Eight patients are enrolled in each age cohort (Cohort 3: at least 30 days, no more than 3 months; Cohort 4: over 3 months, no more than 2 years). [AS PER AMENDMENT 3/11/98: This study is now a 3-part Phase I/II trial. Parts A and B are as above. Part C will assess the quadruple regimen of d4T, 3TC, NVP and NFV. Up to 8 patients will be enrolled in each age cohort (Cohort 5: at least 15 days, no more than 3 months; Cohort 6: over 3 months, no more than 2 years). If 3 of 4 patients in either cohort of Part B do not achieve plasma RNA less than 1,000 copies/ml after 16 weeks of quadruple therapy, enrollment of patients to that cohort will stop and enrollment of 8 patients to the corresponding cohort in Part C will begin. For Part C, patients whose RNA level is no more than 1,000 copies/ml at Week 16 will remain on assigned treatment until Week 104. If at any time between Weeks 16 and 104 a patient's RNA level increases to greater than 1,000 copies/ml, plasma RNA will be repeated within 1 week. If both RNA levels are greater than 1,000 copies/ml, the patient will discontinue study treatment and be followed every 12 weeks for 1 year.] [AS PER AMENDMENT 4/14/99: The study has been extended for an additional 96 weeks for children with continued suppression of viral replication (RNA less than 400 copies/ml) at Week 104. If at any time between Week 12 or 16 and Week 200 a patient's RNA level increases to greater than 1,000 copies/ml, plasma RNA will be repeated within 1 week. If both RNA levels are above 1,000 copies/ml, the patient will discontinue treatment for best available therapy and be followed every 12 weeks for 1 year following the discontinuation of study treatment.] [AS PER AMENDMENT 9/16/99: An additional cohort (Cohort 7) of 5 to 10 patients has been added. Cohort 7 includes patients between 15 days and 3 months of age. Cohort 7 patients who experience suppression of viral replication at Week 104 are followed through Week 200.]
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 2 Years
linkedct:eligibility_minimum_age N/A
linkedct:end_date January 2005
linkedct:enrollment 62 (xsd:int)
linkedct:firstreceived_date November 2, 1999
linkedct:id NCT00000872
rdfs:label Trial NCT00000872
linkedct:lastchanged_date August 6, 2009
linkedct:lead_sponsor_agency National Institute of Allergy and Infectious Diseases (NIAID)
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linkedct:nct_id NCT00000872
linkedct:number_of_arms 7 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Early Intensive Antiretroviral Combination Therapy in HIV-1 Infected Infants and Children
linkedct:org_study_id ACTG 356
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/32004>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2920>
foaf:page <http://clinicaltrials.gov/show/NCT00000872>
linkedct:phase Phase 2
linkedct:primary_completion_date January 2005
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/74936>
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/74937>
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linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/75023>
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linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/75262>
linkedct:reference <http://static.linkedct.org/resource/reference/11930>
linkedct:reference <http://static.linkedct.org/resource/reference/2260>
linkedct:reference <http://static.linkedct.org/resource/reference/22609>
linkedct:reference <http://static.linkedct.org/resource/reference/2261>
linkedct:reference <http://static.linkedct.org/resource/reference/55598>
linkedct:reference <http://static.linkedct.org/resource/reference/631>
linkedct:secondary_id DAIDS-ES ID 10605
linkedct:secondary_id PACTG 356
linkedct:source National Institute of Allergy and Infectious Diseases (NIAID)
linkedct:start_date May 1997
linkedct:study_design Treatment, Non-Randomized, Open Label, Parallel Assignment, Pharmacokinetics Study
linkedct:study_type Interventional
linkedct:summary This trial tests the safety and effectiveness of the early use of combinations of anti-HIV drugs in HIV-infected infants and young children in an effort to block virus growth and preserve normal immune functions. Various anti-HIV drug combinations need to be tested in order to find the best way to treat infants and children who have been infected with HIV during birth.
rdf:type linkedct:trials
linkedct:verification_date August 2009