Completed
1592U89 Therapy for Pediatric HIV Infection
What is being tested
Abacavir sulfate
Drug
Who is being recruted
Blood-Borne Infections+11
+ Urogenital Diseases
+ Genital Diseases
From 6 Months to 13 Years
+11 Eligibility Criteria
How is the trial designed
Treatment Study
Interventional
Summary
Principal SponsorGlaxo Wellcome
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
This is an open-label, non-randomized study. All patients will be treated with 1592U89. Additionally, since optimal therapy usually includes the combined use of 2 or more antiretroviral agents in advanced patients, other novel antiretroviral therapies may be accessed through commercial means or via compassionate use programs. NOTE: 1592U89 should not be administered as a single new agent added to a failing treatment regimen.
Principal SponsorGlaxo Wellcome
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
250 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 6 Months to 13 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsHIV Infections
Criteria
6 inclusion criteria required to participate
High risk for disease progression or mortality as defined by either of the following: Viral load > 100,000 copies/ml and CD4 cells < 15% of total lymphocyte count despite at least 4 weeks of therapy with commercially available antiretrovirals or as a result of no therapy due to treatment-limiting toxicity of ZDV, 3TC, and ddI; or HIV-associated encephalopathy refractory to ZDV-containing regimen
No access to any 1592U89 pediatric study where the patient could qualify for inclusion
Parent or legal guardian with the ability to understand and provide written consent for the patient to participate in the trial. Study patients over 13 years should also give written informed consent whenever possible
Patients must have documented HIV infection
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5 exclusion criteria prevent from participating
Documented hypersensitivity to 1592U89 or any other nucleoside analogue
Hepatic failure evident by Grade 3 or 4 hyperbilirubinemia and AST > 10 X upper limits of normal
In the investigator's opinion, the patient is unlikely to comply with the requirements of the study
Life-threatening infection or other chronic disease that may interfere with taking 1592U89 or compromise the patient's safety
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Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
CompletedOne Study Center