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A Study of 1592U89 in HIV-Infected Adults

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002200
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
NIH AIDS Clinical Trials Information Service
  Purpose
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.

Condition Intervention
HIV Infections Drug: Abacavir sulfate

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A 1592U89 Open-Label Protocol for Adult Patients With HIV-1 Infection.

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   13 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002200


Locations
United States, North Carolina
Glaxo Wellcome Inc
Research Triangle Park, North Carolina, United States, 277093398
Sponsors and Collaborators
Glaxo Wellcome
  More Information

ClinicalTrials.gov Identifier: NCT00002200     History of Changes
Other Study ID Numbers: 238M
CNAA3008
First Submitted: November 2, 1999
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
Last Verified: December 1998

Keywords provided by NIH AIDS Clinical Trials Information Service:
HIV-1
Administration, Oral
CD4 Lymphocyte Count
RNA, Viral
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Viral Load
abacavir

Additional relevant MeSH terms:
Infection
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