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Sponsored by: |
Glaxo Wellcome |
Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002409 |
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.
Condition | Intervention | Phase |
HIV Infections |
Drug: Lamivudine/Zidovudine Drug: Abacavir sulfate |
Phase III |
MedlinePlus related topics: | AIDS |
ChemIDplus related topics: | Zidovudine Abacavir Abacavir sulfate Lamivudine Combivir |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | 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 |
Estimated Enrollment: | 200 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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.
Show 25 Study Locations |
Glaxo Wellcome |
Study Chair: | K Rawlings |
Study ID Numbers: | 280B, NZTA 4006 |
First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002409 |
Health Authority: | United States: Food and Drug Administration |
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