Clinical Trials


A Study of 1592U89 in HIV-Infected Patients

This study has been completed
Glaxo Wellcome

Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service Identifier

First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: November 1998
History of Changes


The purpose of this study is to see if it is safe to give 1592U89 to HIV-infected patients. This study also examines the effect 1592U89 has on plasma viral load (the level of HIV in the blood).

Condition Intervention Phase
HIV Infections

Drug : Abacavir sulfate
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Study to Evaluate the Single-Dose and Steady-State Pharmacokinetics/Dynamics of 1592U89 and Its Active Moiety, 1144U88 5'-Triphosphate (1144U88-TP) Following Six Different Dosing Regimens of 1592U89 in HIV-1 Infected Subjects

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Enrollment: 48

Detailed Description:

Cohorts of 8 patients are entered sequentially into 1 of 6 1592U89 dosing regimens. All patients receive 12 weeks of monotherapy during the initial 12-week treatment phase.
On completion of the treatment phase, patients are offered continuation therapy with 1592U89 for a minimum of 12 weeks.



Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  


Inclusion Criteria
Concurrent Medication:
Prophylaxis for opportunistic infections.
Patients must have:

  • HIV-1 infection.
  • CD4 cell count 100 - 500 cells/mm3 within 3 to 5 weeks prior to study drug administration.
  • No active diagnosis of AIDS (other than non-visceral Kaposi's sarcoma) according to the 1993 CDC AIDS surveillance definition.

  • Exclusion Criteria
    Co-existing Condition:
    Patients with the following conditions and symptoms are excluded:
  • Malabsorption syndrome or other gastrointestinal dysfunction that may interfere with drug absorption.
  • Chronic disease such as diabetes, congestive heart failure, cardiomyopathy, or other cardiac dysfunction that in the opinion of the investigator, would compromise the safety of the patient.

  • Concurrent Medication:
  • Immunomodulating agents.
  • Chemotherapeutic agents.
  • Antiretroviral therapy. NOTE:
  • Patients who elect to continue study treatment into the extended phase may, after consultation with their primary physician, combine 1592U89 at a recommended dose of 300 mg bid with other licensed antiretroviral drugs.

  • Concurrent Treatment:
    Radiation therapy.
    Patients with the following prior conditions are excluded:
  • History of clinically relevant hepatitis or pancreatitis within 6 months prior to study drug administration.
  • History of hypersensitivity, anaphylactic, or idiosyncratic reaction to nucleoside analogs.

  • Prior Medication:
  • Treatment with immunomodulating or cytotoxic chemotherapeutic agents within six weeks prior to study drug administration.
  • Antiretroviral therapy within 2 weeks prior to administration of study drugs.
Prior Treatment:
Radiation therapy within six weeks prior to study drug administration. Current alcohol or illicit controlled substance use that in the opinion of the investigator, may interfere with the patient's ability to complete the study.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00002388


United States, Illinois
Evanston Hosp / Clinical Pharmacology Unit
Evanston, Illinois, United States, 60201
United States, Massachusetts
Fenway Community Health Ctr / Research Dept
Boston, Massachusetts, United States, 02115
United States, New York
Albany Med College / Albany Med Ctr Hosp
Albany, New York, United States, 12208

Sponsors and Collaborators

Glaxo Wellcome
More Information

More Information

Responsible Party: Glaxo Wellcome Identifier: NCT00002388   History of Changes  
Other Study ID Numbers: 238G  
Study First Received: November 2, 1999  
Last Updated: June 23, 2005  

Keywords provided by NIH AIDS Clinical Trials Information Service:

Reverse Transcriptase Inhibitors
Anti-HIV Agents

Additional relevant MeSH terms:
HIV Infections
Abacavir processed this data on June 01, 2020
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