A Study of 1592U89 in HIV-Infected Adults
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...
Brief Summary
Official Title: “A 1592U89 Open-Label Protocol for Adult Patients With HIV-1 Infection.”
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.
- Study Type: Interventional
- Study Design: Endpoint Classification: Safety Study, Primary Purpose: Treatment
Detailed Clinical Trial Description
Patients receive open-label 1592U89 administered orally in combination with at least one other antiretroviral agent that the patient has not previously received.
Intervention(s) in this Clinical Trial
- Drug: Abacavir sulfate
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 13 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Glaxo Wellcome Industry
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00002200
Study ID Number: 238M
ClinicalTrials.gov Identifier: NCT00002200
Health Authority: United States: Food and Drug Administration
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00002200
