Completed
Safety and Efficacy of 1592U89/ZDV/3TC Combination in HIV-1 Therapy-Experienced Pediatric Patients
What is being tested
Abacavir sulfate
+ Lamivudine
+ Zidovudine
Drug
Who is being recruted
Blood-Borne Infections+11
+ Urogenital Diseases
+ Genital Diseases
From 3 Months to 12 Years
+27 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 3
Interventional
Summary
Principal SponsorGlaxo Wellcome
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
Patients are randomized to receive blinded treatment with ZDV/3TC alone or in combination with 1592U89, orally for 16 weeks. If after the 16-week period certain criteria are met, patients may have the option to switch to open-label treatment for the remainder of the study period.
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.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 3 Months to 12 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
7 inclusion criteria required to participate
Any of the CDC Categories: 1, 2, 3, and N, A, B, and C of the 1994 Revised Classification System for HIV Infection in Children Less than 13 Years of Age
CD4+ count >= 15% within 14 days prior to study drug administration
HIV-1 infection documented by: < 18 months of age: one positive viral test culture and one other positive viral test (culture, PCR, p24 antigen, or Immune Complex Dissociation p24 antigen) on two different specimens. >= 18 months of age: two positive viral tests as stated above, one or both of which may be determined by a federally documented ELISA and confirmed by Western blot or Indirect Fluorescent Antibody test
Intravenous immunoglobulin G, erythropoietin, G-CSF and GM-CSF allowed
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20 exclusion criteria prevent from participating
> 12 weeks prior antiretroviral therapy and unchanged therapy 12 weeks prior to screening
Biologic response modifier (unless listed under included concurrent medication) and megestrol acetate
Documented hypersensitivity to a nucleoside analog
Grade 3/4 clinical or laboratory toxicity or current grade 2 or higher pancreatic amylase or lipase toxicity as defined by the ACTG Toxicity Tables within 14 days prior to study entry
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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 30 locations
Univ Alabama - Birmingham / Dept of Pediatrics / UAB Station
Birmingham, United StatesOpen Univ Alabama - Birmingham / Dept of Pediatrics / UAB Station in Google MapsChildren's Hosp Los Angeles
Los Angeles, United StatesLos Angeles County - USC Med Ctr
Los Angeles, United StatesChildren's Diagnostic Treatment Ctr
Fort Lauderdale, United StatesCompleted30 Study Centers