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| Tracking Information | |
|---|---|
| First Received Date ICMJE | November 2, 1999 |
| Last Updated Date | June 23, 2005 |
| Start Date ICMJE | |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00002217 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | A Study of Combivir Plus Abacavir Plus 141W94 in Patients Who Previously Have Used Anti-HIV Drugs |
| Official Title ICMJE | Combivir, 1592U89, 141W94 Triple Antiretroviral, Experienced Patient Trial |
| Brief Summary | The purpose of this study is to test the effectiveness of Combivir plus abacavir plus 141W94 in patients who previously have used anti-HIV drugs. |
| Detailed Description | In this open-label study antiretroviral-experienced patients receive Combivir (3TC/AZT tablet) plus 1592U89 (abacavir) and 141W94 twice daily for 48 weeks. |
| Study Phase | |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Treatment, Open Label, Safety Study |
| Condition ICMJE | HIV Infections |
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |
| Publications * | Henry K, Wallace RJ, Bellman PC, Norris D, Fisher RL, Ross LL, Liao Q, Shaefer MS. Twice-daily triple nucleoside intensification treatment with lamivudine-zidovudine plus abacavir sustains suppression of human immunodeficiency virus type 1: results of the TARGET Study. J Infect Dis. 2001 Feb 15;183(4):571-8. |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | |
| Completion Date | |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | Inclusion Criteria Patients must have:
Prior Medication: Allowed: AZT or non-nucleoside reverse transcriptase inhibitors (NNRTIs). Exclusion Criteria Co-existing Condition: Patients with any of the following symptoms or conditions are excluded:
Concurrent Medication: Excluded:
Patients with the following prior conditions are excluded: History of clinically relevant pancreatitis or hepatitis within the past 6 months. Required: Antiretroviral therapy with either single or double reverse transcriptase inhibitors. |
| Gender | Both |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00002217 |
| Responsible Party | |
| Study ID Numbers ICMJE | 280D, UNAP 12, NZTA 4005 |
| Study Sponsor ICMJE | Glaxo Wellcome |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | NIH AIDS Clinical Trials Information Service |
| Verification Date | May 1999 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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