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| Sponsor: | Glaxo Wellcome |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002364 |
Purpose
To obtain preliminary evidence of antiretroviral activity of 1592U89 when administered in combination with other specific NRTI agents in NRTI experienced patients and to assess the safety and tolerance of multiple oral doses of 1592U89 when administered in combination with specific marketed NRTIs.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Abacavir sulfate |
Phase II |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Primary Purpose: Treatment |
| Official Title: | An Exploratory Study of the Antiretroviral Activity of 1592U89 When Administered in Combination With Other Specific Nucleoside Reverse Transcriptase Inhibitors (NRTIs) in NRTI Experienced Patients |
| Estimated Enrollment: | 40 |
Patients will all receive oral doses of 1592U89 in combination with protocol specific current antiretroviral therapy. The treatment groups will be assigned based on each subject's previous NRTI experience.
The study medication is self administered and all evaluations will be performed on an outpatient basis. Patients will be seen at day 0 and weeks 2, 4, 12, 16, 20 and 24.
Eligibility| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with any of the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Concurrent Treatment:
Excluded:
Patients with any of the following prior conditions are excluded:
Prior Medication:
Excluded:
Prior Treatment:
Excluded:
Risk Behavior:
Excluded:
Patients with current alcohol or illicit drug use that, in the opinion of the principal investigator, may interfere with the patient's ability to comply with the study protocol.
Contacts and Locations| United States, California | |
| Marin County Specialty Clinic | |
| Greenbrae, California, United States, 94904 | |
| Kraus Med Partners | |
| Los Angeles, California, United States, 90036 | |
| ViRx Inc | |
| San Francisco, California, United States, 94109 | |
| United States, Florida | |
| IDC Research Initiative | |
| Altamonte Springs, Florida, United States, 32701 | |
| North Broward Hosp District | |
| Fort Lauderdale, Florida, United States, 33316 | |
| United States, Georgia | |
| AIDS Research Consortium of Atlanta | |
| Atlanta, Georgia, United States, 30308 | |
| United States, Kentucky | |
| Univ of Kentucky Med Ctr | |
| Lexington, Kentucky, United States, 40536 | |
| United States, New York | |
| Beth Israel Med Ctr | |
| New York, New York, United States, 10003 | |
More Information
| ClinicalTrials.gov Identifier: | NCT00002364 History of Changes |
| Other Study ID Numbers: | 238C, CNAA 2003 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
|
Drug Therapy, Combination Acquired Immunodeficiency Syndrome AIDS-Related Complex Antiviral Agents |
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
Reverse Transcriptase Inhibitors Abacavir Anti-HIV Agents Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses |