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| Sponsor: | Glaxo Wellcome |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002197 |
Purpose
The purpose of this study is to see if it is safe to give 1592U89 to children (aged 6 months until 14th birthday) with advanced HIV infection who have few treatment options available. The study also examines the effect 1592U89 has on the levels of HIV in the blood.
| Condition | Intervention |
|---|---|
|
HIV Infections |
Drug: Abacavir sulfate |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Safety Study |
| Official Title: | 1592U89 Open-Label Protocol for Pediatric Patients With HIV Infection. |
| Estimated Enrollment: | 250 |
This is an open-label, non-randomized study. All patients will be treated with 1592U89. Additionally, since optimal therapy usually includes the combined use of 2 or more antiretroviral agents in advanced patients, other novel antiretroviral therapies may be accessed through commercial means or via compassionate use programs. NOTE: 1592U89 should not be administered as a single new agent added to a failing treatment regimen.
Eligibility| Ages Eligible for Study: | 6 Months to 13 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with any of the following symptoms or conditions are excluded:
Patients with the following prior conditions are excluded:
Documented hypersensitivity to 1592U89 or any other nucleoside analogue.
See Inclusion - General Criteria.
Contacts and Locations
More Information
| Study ID Numbers: | 238E, CNAA3007 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002197 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
HIV-1 CD4 Lymphocyte Count Reverse Transcriptase Inhibitors |
Anti-HIV Agents Viral Load abacavir |
|
Anti-Infective Agents Communicable Diseases RNA Virus Infections Sexually Transmitted Diseases, Viral Anti-HIV Agents Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Infection Antiviral Agents |
Pharmacologic Actions Immunologic Deficiency Syndromes Reverse Transcriptase Inhibitors Virus Diseases Anti-Retroviral Agents HIV Infections Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections Abacavir Retroviridae Infections Nucleic Acid Synthesis Inhibitors |