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

Glaxo Wellcome25 sites in 1 country200 target enrollmentAugust 31, 2001

ConditionsHIV Infections

DrugsLamivudine/Zidovudine Abacavir sulfate

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: HIV Infections
Sponsor: Glaxo Wellcome
Enrollment: 200
Locations: 25
Status: Completed
Last Updated: 20 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

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.

Registry

clinicaltrials.gov

Start Date

August 31, 2001

End Date

TBD

Last Updated

20 years ago

Study Type

Interventional

Sex

All