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Trial NCT00001118

Resource URI: http://static.linkedct.org/resource/trials/NCT00001118
PropertyValue
linkedct:brief_title Study of a New Anti-HIV Drug, T-20, in HIV-Infected Children
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 3 to 12 years old (consent of parent or guardian required). - Are HIV-positive. - Are receiving combination anti-HIV therapy. He/she must have been taking this combination for at least 16 weeks, and it must include either 2 NRTIs alone or 2 NRTIs plus either an NNRTI or a PI. (This study has been changed. This no longer has to be a child's first anti-HIV drug combination.) - Have a viral load greater than 10,000 copies/ml while taking this anti-HIV drug combination. - Have never received treatment with a PI or an NNRTI. (One or two doses are allowed.) - Have never taken at least 1 NRTI. Exclusion Criteria Children will not be eligible for this study if they: - Are receiving treatment for an opportunistic (AIDS-related) or serious bacterial infection at the time of study entry. - Are receiving chemotherapy for cancer. - Have certain serious diseases (other than HIV) or conditions. - Have received or are currently receiving certain medications. - Are pregnant.
linkedct:description T-20 is the first drug to be developed which specifically inhibits the function of the gp41 transmembrane glycoprotein. By inhibiting the essential protein-protein surface interaction, T-20 is able to block the process of virus-to-host cell membrane fusion. Combination antiretroviral regimens (reverse transcriptase inhibitors plus PIs) have benefited many HIV patients, but heavily pretreated patients often develop multi-drug resistance via multiple gene mutations. A pharmacologic agent, such as T-20, that is effective at an alternative point in the virus replication cycle will make a valuable addition to the treatment of HIV infection. This Phase I/II open-label, dose-escalating, randomized study is divided into 2 parts. Patients may participate in Part A and/or Part B. Part A (single dosing): 12 patients are sequentially assigned to receive 1 of 3 doses of T-20 given once on Day 0 by SC injection into the abdomen, deltoid area, or anterior aspect of the thigh and once on Day 1 by IV infusion. Provided safety criteria are met, patients who complete Part A, or new enrollees who did not participate in Part A, enroll in Part B. Doses for Part B are determined by pharmacokinetic data obtained in Part A. [AS PER AMENDMENT 4/20/00: Current data has now projected a pediatric dose. Each child will move to chronic dosing in Part B provided the child has no Grade 3 or higher toxicity to study drug through Day 7 in Part A.] Part B (multiple dosing): Patients are randomly assigned to 1 of 3 dose cohorts to receive 24 weeks [AS PER AMENDMENT 12/7/00: 48 weeks] of treatment (optional extension to 48 weeks [AS PER AMENDMENT 12/7/00: 96 weeks]) with bid SC injections of T-20. Cohort 1 receives the dose identified in Part A (Dose 1) as the lowest dose that is well tolerated and that achieves the target trough plasma concentration. Cohort 2 receives the next higher dose from Dose 1 (Dose 2). Cohort 3 receives either Dose 1 or Dose 2, depending on the tolerability and antiviral activity of each dose. [AS PER AMENDMENT 4/20/00: Cohort 1 receives 30 mg/m2 SC bid (Dose 1); Cohort 2 receives 60 mg/m2 SC bid (Dose 2); and Cohort 3 receives Dose 1 or 2 SC bid.] On Day 7 of T-20 dosing, children begin a new antiretroviral therapy regimen chosen by the site investigator based on study parameters. (Abacavir and amprenavir are not allowed for this regimen.) [AS PER AMENDMENT 1/6/00: Abacavir and amprenavir are now allowed.] The first injection will be given in the clinic and a parent/guardian will be trained to give successive injections. [AS PER AMENDMENT 4/20/00: The 2 doses given prior to obtaining trough levels on Days 1 and 7 must be directly observed by medical personnel.] Patients undergo clinical and laboratory evaluations to monitor viral load, HIV-related symptoms, and pharmacokinetics at time points throughout the study. Patients participating in Part A are evaluated at the clinic on Days 0, 1, and 7. Patients participating in Part B are evaluated at the clinic 6 times during the first 3 weeks and then every 4 weeks through Week 24. [AS PER AMENDMENT 12/7/00: Patients participating in Part B are evaluated at the clinic 6 times during the first 3 weeks, every 4 weeks through Week 24, and then every 8 weeks through Week 48.]
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 3 Years
linkedct:enrollment 24 (xsd:int)
linkedct:firstreceived_date November 2, 1999
linkedct:id NCT00001118
rdfs:label Trial NCT00001118
linkedct:lastchanged_date September 12, 2008
linkedct:lead_sponsor_agency National Institute of Allergy and Infectious Diseases (NIAID)
linkedct:location <http://static.linkedct.org/resource/location/105307>
linkedct:location <http://static.linkedct.org/resource/location/146815>
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linkedct:location <http://static.linkedct.org/resource/location/147801>
linkedct:location <http://static.linkedct.org/resource/location/151107>
linkedct:location <http://static.linkedct.org/resource/location/152982>
linkedct:location <http://static.linkedct.org/resource/location/153748>
linkedct:location <http://static.linkedct.org/resource/location/154169>
linkedct:location <http://static.linkedct.org/resource/location/154391>
linkedct:location <http://static.linkedct.org/resource/location/154431>
linkedct:location <http://static.linkedct.org/resource/location/154945>
linkedct:location <http://static.linkedct.org/resource/location/156523>
linkedct:location <http://static.linkedct.org/resource/location/161675>
linkedct:location <http://static.linkedct.org/resource/location/161840>
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linkedct:location <http://static.linkedct.org/resource/location/171716>
linkedct:location <http://static.linkedct.org/resource/location/174045>
linkedct:location <http://static.linkedct.org/resource/location/186734>
linkedct:location <http://static.linkedct.org/resource/location/197412>
linkedct:location <http://static.linkedct.org/resource/location/209972>
linkedct:location <http://static.linkedct.org/resource/location/211745>
linkedct:location <http://static.linkedct.org/resource/location/213279>
linkedct:location <http://static.linkedct.org/resource/location/216582>
linkedct:nct_id NCT00001118
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title A Phase I/II Study of T-20, a Fusion Inhibitor, in HIV-1 Infected Children
linkedct:org_study_id ACTG P1005
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/10369>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/30295>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00001118>
linkedct:phase Phase 1
linkedct:reference <http://static.linkedct.org/resource/reference/1976>
linkedct:results_reference <http://static.linkedct.org/resource/results_reference/2910>
linkedct:results_reference <http://static.linkedct.org/resource/results_reference/3514>
linkedct:results_reference <http://static.linkedct.org/resource/results_reference/4011>
linkedct:secondary_id PACTG P1005
linkedct:secondary_id T20-204
linkedct:source National Institute of Allergy and Infectious Diseases (NIAID)
linkedct:study_design Treatment, Dose Comparison, Pharmacokinetics Study
linkedct:study_type Interventional
linkedct:summary The purpose of this study is to determine the best dose of T-20, a new anti-HIV drug, to treat HIV-infected children. T-20, unlike other anti-HIV medications, lessens the ability of HIV to infect certain cells (T cells) in the body. Doctors hope to better treat HIV by adding T-20 to anti-HIV drug combinations that include 1 or 2 nucleoside reverse transcriptase inhibitors (NRTIs) plus a nonnucleoside reverse transcriptase inhibitor (NNRTI) and/or a protease inhibitor (PI).
rdf:type linkedct:trials
linkedct:verification_date November 2004