A Study of 1592U89 in HIV-Infected Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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The purpose of this study is to see if it is safe and effective to give 1592U89 to HIV-positive adults. This study also examines the influence previous anti-HIV treatment has on the effectiveness of 1592U89.

Detailed Description

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Patients receive open-label 1592U89 administered orally in combination with at least one other antiretroviral agent that the patient has not previously received.

Conditions

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HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Abacavir sulfate

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Concurrent Medication:

Allowed:

Erythropoietin, G-CSF and GM-CSF.

Patients must have:

* CD4+ cell count \< 100 cells/mm3.
* HIV-1 RNA \> 30,000 copies/ml.
* Signed, informed consent from parent or legal guardian for patient under 18 years of age.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* Renal failure requiring dialysis.
* Hepatic failure evident by grade 3/4 hyperbilirubinemia and AST 5 times the upper limit of normal.
* Documented hypersensitivity to 1592U89.
* Serious medical conditions, such as diabetes, congestive heart failure, cardiomyopathy, or other cardiac dysfunction, that would compromise the safety of the patient.
* Participation in or ability to participate in an enrolling study of 1592U89.

Required:

At least 2 nucleoside reverse transcriptase inhibitors (NRTI) and one protease inhibitor (or intolerance to one protease inhibitor and one NRTI due to trying at least 2 different regimens with at least one protease inhibitor).

Alcohol or illicit drug use that may interfere with the patient's compliance.

Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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Glaxo Wellcome Inc

Research Triangle Park, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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CNAA3008

Identifier Type: -

Identifier Source: secondary_id

238M