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| Tracking Information | |||||
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| 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 NCT00002409 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Effect of Teaching HIV-Infected Patients About HIV and Treatment | ||||
| Official Title ICMJE | A Phase IIIB, Open-Label, Randomized Study of the Effect of an Education Intervention on Virological Outcomes, Adherence, Immunological Outcome, and Health Outcomes in HIV-Infected Subjects From Under-Represented Populations Treated With Triple Nucleoside Therapy (Combivir, Lamivudine 150 Mg/Zidovudine 300 Mg PO BID Plus Abacavir 300 Mg PO BID) for Twenty-Four Weeks | ||||
| Brief Summary | The purpose of this study is to see if an HIV-education course can help under-represented, HIV-infected patients. This study examines the areas of faithfulness to drug regimen, level of HIV in the blood, and health status. |
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| Detailed Description | Following initial screening, eligible patients are treated with open-label Combivir plus abacavir for 24 weeks. Patients are randomized to undergo the education intervention, Tools for Health and Empowerment (T.H.E.) course plus counseling, or routine counseling only (control group). Measurements and evaluations for assessment of immunologic effects, adherence, and health outcomes are performed at entry (Day 1) and at Weeks 2, 5, 8, 12, 16, and 24. |
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| Study Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment | ||||
| Condition ICMJE | HIV Infections | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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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 | 200 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria Patients must have:
Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded:
Concurrent Treatment: Excluded: Treatment with foscarnet or other agents with required documented activity against HIV-1 in vitro. Patients with the following prior conditions are excluded:
Prior Medication: Excluded:
Prior Treatment: Excluded: Radiation therapy or cytotoxic chemotherapeutic agents received within 4 weeks prior to entry. Risk Behavior: Excluded: Current alcohol or illicit drug use which may interfere with the ability to comply with dosing schedule and protocol evaluation and assessment. |
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| 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 | NCT00002409 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 280B, NZTA 4006 | ||||
| Study Sponsor ICMJE | Glaxo Wellcome | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | NIH AIDS Clinical Trials Information Service | ||||
| Verification Date | June 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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