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| Descriptive Information Fields | |
| Brief Title † | A Study of 1592U89 Combined With Other Anti-HIV Drugs in Patients Who Have Taken Anti-HIV Drugs |
| 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 |
| Brief Summary | 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. |
| Detailed Description | 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. |
| Study Phase | Phase II |
| Study Type † | Interventional |
| Study Design † | Treatment, Safety Study |
| Primary Outcome Measure † | |
| Secondary Outcome Measure † | |
| Condition † | HIV Infections |
| Intervention † | Drug: Abacavir sulfate |
| MEDLINE PMIDs | |
| Links | |
| Recruitment Information Fields | |
| Recruitment Status † | Completed |
| Enrollment † | 40 |
| Start Date † | |
| Completion Date | |
| Eligibility Criteria † | 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. |
| Gender | Both |
| Ages | 13 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts †† | |
| Location Countries † | United States |
| Administrative Information Fields | |
| NCT ID † | NCT00002364 |
| Organization ID | 238C |
| Secondary IDs †† | CNAA 2003 |
| Study Sponsor † | Glaxo Wellcome |
| Collaborators †† | |
| Investigators † | |
| Information Provided By | NIH AIDS Clinical Trials Information Service |
| Verification Date | April 1997 |
| First Received Date † | November 2, 1999 |
| Last Updated Date | June 23, 2005 |