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Trial NCT00000913

Resource URI: http://static.linkedct.org/resource/trials/NCT00000913
PropertyValue
linkedct:brief_title A Study to Compare Two Anti-HIV Combination Therapies Each Containing Saquinavir in HIV-Positive Children
linkedct:condition <http://static.linkedct.org/resource/condition/5486>
linkedct:criteria Inclusion Criteria Your child may be eligible for this study if he or she: - Is HIV-positive. - Is 3 to 16 years of age (consent of parent or guardian is required). - Has an HIV level greater than 10,000 copies/ml. - Has never taken at least one of the following anti-HIV drugs: lamivudine, zidovudine, stavudine, or didanosine. - Is able to swallow capsules and tablets. Exclusion Criteria Your child will not be eligible if he or she: - Has cancer requiring chemotherapy. - Has an acute opportunistic (AIDS-related) infection requiring therapy. - Has had two or more episodes of moderate or severe diarrhea or vomiting in the 3 months prior to study entry. - Has ever taken SQV or NFV. - Is pregnant or breast-feeding. - Is taking certain medications, including those that would interfere with the study drugs.
linkedct:description Clinical trials in adults and children suggest that SQV-SGC has advantages over other protease inhibitors in terms of tolerability, safety, and effectiveness in patients who have failed therapy with other protease inhibitors. [AS PER AMENDMENT 11/24/99: Pharmacokinetic data from this study demonstrate lower than expected plasma SQV exposures, particularly in Arm 1. Based on these data, patients in the study will be offered the opportunity to adjust their doses. Ritonavir added to the Arm 1 regimen is expected to significantly increase SQV-SGC plasma levels and allow twice-daily dosing for SQV-SGC.] Patients are randomized to one of two study arms. Patients in Arm 1 receive SQV-SGC plus two [AS PER AMENDMENT 11/24/99: one or two] NRTIs of choice. Patients in Arm 2 receive SQV-SGC plus NFV plus one or two NRTIs of choice. All participants are evaluated by physical examinations and laboratory tests during the study and are followed for incidence of death, cancer, or fetal abnormality. NRTIs are not provided as part of this study. [AS PER AMENDMENT 11/24/99: This study is closed to accrual. All subjects on follow-up (Cohort 1) are given the option of either discontinuing participation in ACTG 397 or participating in the next phase of the study (version 2.0). Those electing to continue participation constitute Cohort 1A. The adjusted Arm 1 regimen consists of SQV-SGC plus ritonavir plus one or two NRTIs. Ritonavir is not provided as part of this study. The Arm 2 regimen study drugs have not changed but the maximum allowable dose of SQV-SGC has increased from 1,200 mg twice-daily to 1,600 mg twice-daily. Participants continue to be followed with physical examinations and laboratory evaluations that include an intensive pharmacokinetics study on Day 14 of the new regimen.]
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 16 Years
linkedct:eligibility_minimum_age 3 Years
linkedct:end_date August 2007
linkedct:enrollment 50 (xsd:int)
linkedct:firstreceived_date November 2, 1999
linkedct:id NCT00000913
rdfs:label Trial NCT00000913
linkedct:lastchanged_date September 26, 2008
linkedct:lead_sponsor_agency National Institute of Allergy and Infectious Diseases (NIAID)
linkedct:location <http://static.linkedct.org/resource/location/105306>
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linkedct:location <http://static.linkedct.org/resource/location/220112>
linkedct:nct_id NCT00000913
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title A Randomized Trial of Two Saquinavir-Containing Combination Treatment Regimens in Children With HIV Infection
linkedct:org_study_id ACTG 397
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/10609>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/38243>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000913>
linkedct:phase Phase 2
linkedct:reference <http://static.linkedct.org/resource/reference/1955>
linkedct:reference <http://static.linkedct.org/resource/reference/1956>
linkedct:reference <http://static.linkedct.org/resource/reference/531>
linkedct:reference <http://static.linkedct.org/resource/reference/532>
linkedct:source National Institute of Allergy and Infectious Diseases (NIAID)
linkedct:study_design Treatment, Pharmacokinetics Study
linkedct:study_type Interventional
linkedct:summary The purpose of this study is to determine the safety and effectiveness of a soft-gel capsule formulation of saquinavir (SQV-SGC), a protease inhibitor, when given in combination with other anti-HIV drugs. SQV-SGC has been tested in adults for the treatment of HIV infection, but more information is still needed about SQV-SGC in children. Recent studies suggest that this soft-gel capsule form may be safer and more effective than other protease inhibitors.
rdf:type linkedct:trials
linkedct:verification_date August 2004