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A Study of 1592U89 in HIV-Infected Adults

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Abacavir sulfate
Sponsored by
Glaxo Wellcome
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV-1, Administration, Oral, CD4 Lymphocyte Count, RNA, Viral, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load, abacavir

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Glaxo Wellcome Inc

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Glaxo Wellcome
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1. Study Identification

Unique Protocol Identification Number
NCT00002200
Brief Title
A Study of 1592U89 in HIV-Infected Adults
Official Title
A 1592U89 Open-Label Protocol for Adult Patients With HIV-1 Infection.
Study Type
Interventional

2. Study Status

Record Verification Date
December 1998
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Glaxo Wellcome

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV-1, Administration, Oral, CD4 Lymphocyte Count, RNA, Viral, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load, abacavir

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Abacavir sulfate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Glaxo Wellcome Inc
City
Research Triangle Park
State/Province
North Carolina
ZIP/Postal Code
277093398
Country
United States

12. IPD Sharing Statement

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A Study of 1592U89 in HIV-Infected Adults

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