A Study of 1592U89 in HIV-Infected Patients
Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
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).
Drug : Abacavir sulfate
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:
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|
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.
- 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.
- 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.
- 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.
- 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.
Patients with the following conditions and symptoms are excluded:
Patients with the following prior conditions are excluded:
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 LocationsChoosing 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 ClinicalTrials.gov identifier: NCT00002388
Locations Show More
|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 CollaboratorsGlaxo Wellcome
|Responsible Party:||Glaxo Wellcome|
|ClinicalTrials.gov 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:HIV-1
Reverse Transcriptase Inhibitors
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on October 15, 2019
This information is provided by ClinicalTrials.gov.