A Study of 1592U89 in HIV-Infected Patients

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002388
• Other study ID #: 238G
• Secondary ID: CNAA1004
• Status: Completed
• Phase: Phase 1
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: November 1998
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Pharmacokinetics Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Abacavir sulfate

Locations

Country	Name	City	State
United States	Albany Med College / Albany Med Ctr Hosp	Albany	New York
United States	Fenway Community Health Ctr / Research Dept	Boston	Massachusetts
United States	Evanston Hosp / Clinical Pharmacology Unit	Evanston	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Glaxo Wellcome

Country where clinical trial is conducted

United States,