A Study of 1592U89 in HIV-Infected Patients

Completed · Phase 1

Conditions studied: HIV Infections

In brief

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).

Key facts

Study ID

NCT00002388

Run by

Glaxo Wellcome

People needed

48

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Concurrent Medication:
• Allowed:
• 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.

You may not qualify if…

• 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:
• Excluded:
• 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:
• Excluded:
• 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:
• Excluded:
• 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:
• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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