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| Sponsor: | Glaxo Wellcome |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002388 |
Purpose
The purpose of this study is to see if it is safe to give 1592U89 to HIV-infected patients. This study also examines the effect 1592U89 has on plasma viral load (the level of HIV in the blood).
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Abacavir sulfate |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Pharmacokinetics Study |
| Official Title: | A Study to Evaluate the Single-Dose and Steady-State Pharmacokinetics/Dynamics of 1592U89 and Its Active Moiety, 1144U88 5'-Triphosphate (1144U88-TP) Following Six Different Dosing Regimens of 1592U89 in HIV-1 Infected Subjects |
| Estimated Enrollment: | 48 |
Cohorts of 8 patients are entered sequentially into 1 of 6 1592U89 dosing regimens. All patients receive 12 weeks of monotherapy during the initial 12-week treatment phase.
On completion of the treatment phase, patients are offered continuation therapy with 1592U89 for a minimum of 12 weeks.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Prophylaxis for opportunistic infections.
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions and symptoms are excluded:
Concurrent Medication:
Excluded:
Concurrent Treatment:
Excluded:
Radiation therapy.
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
Prior Treatment:
Excluded:
Radiation therapy within six weeks prior to study drug administration. Current alcohol or illicit controlled substance use that in the opinion of the investigator, may interfere with the patient's ability to complete the study.
Contacts and Locations| United States, Illinois | |
| Evanston Hosp / Clinical Pharmacology Unit | |
| Evanston, Illinois, United States, 60201 | |
| United States, Massachusetts | |
| Fenway Community Health Ctr / Research Dept | |
| Boston, Massachusetts, United States, 02115 | |
| United States, New York | |
| Albany Med College / Albany Med Ctr Hosp | |
| Albany, New York, United States, 12208 | |
More Information
| Study ID Numbers: | 238G, CNAA1004 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002388 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
HIV-1 Reverse Transcriptase Inhibitors Anti-HIV Agents |
|
Anti-Infective Agents 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 |