A Study of 1592U89 in HIV-Infected Patients

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
HIV Infections	Drug: Abacavir sulfate	Phase 1

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	48 participants
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

Arms and Interventions

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Outcome Measures

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Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

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.

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:

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.

Contacts and Locations

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Locations

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier:	NCT00002388 History of Changes
Other Study ID Numbers:	238G; CNAA1004
First Posted:	August 31, 2001
Last Update Posted:	June 24, 2005
Last Verified:	November 1998

Keywords provided by NIH AIDS Clinical Trials Information Service:

HIV-1; Reverse Transcriptase Inhibitors; Anti-HIV Agents

Additional relevant MeSH terms:

HIV Infections; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Immunologic Deficiency Syndromes; Immune System Diseases	Abacavir; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Anti-Retroviral Agents; Antiviral Agents; Anti-Infective Agents; Anti-HIV Agents