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Handheld Computers to Improve Adherence to Anti-HIV Drug Regimens



Handheld Computers to Improve Adherence to Anti-HIV Drug Regimens

For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: While anti-HIV drugs can significantly reduce viral loads, the medication regimens can be complex, and patients must take them correctly for the best effect. Nonadherent patients risk developing drug resistant HIV strains. The purpose of this study is to evaluate the effectiveness of a handheld computerized system designed to help patients take their drugs correctly.
Details: As the use of protease inhibitors and other antiretroviral medications has increased, multiple drug resistant HIV strains have emerged, demonstrating the need for improved patient adherence to complex drug regimens. Individual computerized adherence systems have been proposed as a mechanism for improving patient adherence. This study will utilize advanced computer and communication technologies to produce a handheld (PDA) product for HIV/AIDS patients. The system serves as a patient reminder system, addresses problems of missed medications, and monitors severity of side effects. This study will evaluate the efficacy of the system as an adherence intervention. Participants in the study will be randomized to either the intervention or a control group. Participants will use the PDA daily for medication reminders, alarms, adherence tracking, and as a source of information on HIV/AIDS. The study will last 15 weeks. Each participant will have 6 study interviews and 2 quality control interviews. Study interviews will include adherence questionnaires, blood tests for viral load and CD4 data, and quality of life assessments.
Eligibility:
Study Type:  Interventional, Treatment, Randomized, Efficacy Study
Minimum Age/Maximum Age: 16 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria - HIV positive - Currently taking medications for HIV/AIDS.
Total Enrollment: 156

Location and Contact Information:

Inflexxion
Newton,  Massachusetts,  02464
United States
 


Additional Information:
Study ID Numbers:  2R44AI43750-02 A 2;  5R44AI043750-03
Study Start Date: 
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00053443

Other Hiv Infections Studies:
1. Safety and Effectiveness of Giving Isotretinoin to HIV-Infected Women to Treat Cervical Tumors

2. Hormone Replacement Therapy and Anti-HIV Drugs in HIV-Infected, Postmenopausal Women

3. Foscarnet Treatment of Serious CMV Retinitis Infection in Patients With Acquired Immunodeficiency Syndrome

4. Interleukin-2 Plus Anti-HIV Therapy in HIV-Infected Children with Weakened Immune Systems

5. A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of r-HuEPO in AIDS and Advanced ARC Patients With Anemia

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