Completed
1592U89 Safety and Efficacy Evaluation in Patients with AIDS Dementia Complex
What is being tested
Abacavir sulfate
Drug
Who is being recruted
Blood-Borne Infections+20
+ Urogenital Diseases
+ Genital Diseases
From 18 to 65 Years
+26 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 must be on stable antiretroviral treatment for at least 6 weeks prior to study entry and will then be stratified depending on whether their regimen contains zidovudine (ZDV). Each stratum will be randomized separately to receive 1592U89 or placebo for 12 weeks. For the subsequent 40 weeks, open-label 1592U89 will be offered.
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 18 to 65 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 DiseasesMental DisordersBrain DiseasesCentral Nervous System DiseasesCommunicable DiseasesDementiaImmunologic Deficiency SyndromesImmune System DiseasesInfectionsNervous System DiseasesRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsNeurocognitive DisordersAcquired Immunodeficiency SyndromeAIDS Dementia ComplexHIV Infections
Criteria
3 inclusion criteria required to participate
Been on stable antiretroviral treatment for a minimum of 6 weeks prior to study entry
Documented HIV infection
Evidence of HIV - associated dementia
23 exclusion criteria prevent from participating
Chronic diseases such as diabetes, congestive heart failure, cardiomyopathy, other cardiac dysfunctions, etc., which in the investigator's opinion would compromise the safety of the patient
Confounding neurological diseases which may interfere with interpretation of neurological and neurophysical assessments
Current alcohol or illicit drug use which may interfere with the patient's ability to comply with the study protocol
Debilitated as a result of their HIV disease, associated illness or therapies who the investigator determines will not be able to complete the 12 week randomized dosing period
Show More Criteria
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 9 locations
HIV Neurobehavioral Research Ctr
San Diego, United StatesOpen HIV Neurobehavioral Research Ctr in Google MapsSan Francisco Gen Hosp
San Francisco, United StatesJohns Hopkins Univ School of Medicine
Baltimore, United StatesWashington Univ Med Ctr
St Louis, United StatesCompleted9 Study Centers