Completed

1592U89 Safety and Efficacy Evaluation in Patients with AIDS Dementia Complex

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
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
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
See protocol details

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.

NCT00002163
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
Documented HIV infection.

Evidence of HIV - associated dementia.

Been on stable antiretroviral treatment for a minimum of 6 weeks prior to study entry.

23 exclusion criteria prevent from participating
The use of narcotic analgesics, sedatives, benzodiazepines, antidepressants, anti-psychotic agents and other psychoactive drugs which would interfere with the assessment of the neurological and neurophysical status of the patient.

History of clinically apparent pancreatitis in the last 6 months.

HIV vaccine within the past 3 months.

History of clinically apparent hepatitis within the last 6 months.

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 Maps

San Francisco Gen Hosp

San Francisco, United States

Johns Hopkins Univ School of Medicine

Baltimore, United States

Washington Univ Med Ctr

St Louis, United States
Completed9 Study Centers