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Quality of Life and Healthcare Utilization Substudy
The purpose of this study is to compare the effects of two different anti-HIV drug regimens on quality of life and health care utilization among SMART study participants.
Advances in antiretroviral therapy (ART) have dramatically reduced mortality and morbidity rates for HIV infected people. However, HIV infection is a costly disease to treat. With improvement in survival, quality of life and the long-term cost of HIV treatment have become increasingly important to the majority of individuals infected with HIV. Different HIV treatment regimens may lead to variations in quality of life and health care costs over the course of treatment. In the SMART study, participants were randomly assigned to one of two treatment groups: * Group 1 participants followed a drug conservation (DC) regimen in which ART was stopped or deferred until CD4 cell count dropped below 250 cells/mm3, initiated until CD4 cell count was at least 350 cells/mm3, and then followed by episodic ART based on CD4 cell count. * Group 2 participants followed a viral suppression (VS) regimen in which ART was continued to keep viral loads as low as possible, regardless of CD4 cell count. The purpose of this study is to compare how the DC and VS regimens affect quality of life, symptom severity, health care utilization, and resulting costs among SMART study participants. At baseline, participants will complete questionnaires regarding quality of life, symptoms, health care utilization, current insurance, and socioeconomic status. Body appearance and signs of HIV disease progression will also be assessed at this time. Follow-up evaluations on quality of life and symptoms will be repeated at Months 4, 8, and 12 and annually thereafter. Follow-up evaluations of all other baseline measures will occur once a year.
Age
13 - No limit years
Sex
ALL
Healthy Volunteers
No
UCSF, Fresno, School of Medicine, Dept. of Internal Medicine CRS
Fresno, California, United States
Dr. M. Estes Med. Practice CRS
Mill Valley, California, United States
Dr. Robert Scott Med. Practice CRS
Oakland, California, United States
East Bay AIDS Ctr. CRS
Oakland, California, United States
Dr. Shawn Hassler Med. Practice CRS
San Francisco, California, United States
Positive Health Program Clinic (San Francisco Gen. Hosp.) CRS
San Francisco, California, United States
Dr. Virginia Cafaro Med. Practice CRS
San Francisco, California, United States
Dr. William Owen Med. Practice CRS
San Francisco, California, United States
Castro-Mission Health Ctr. CRS
San Francisco, California, United States
San Francisco VAMC, Infectious Diseases Clinic CRS
San Francisco, California, United States
Start Date
January 1, 2002
Primary Completion Date
November 1, 2008
Completion Date
November 1, 2008
Last Updated
April 21, 2014
1,224
ACTUAL participants
Antiretroviral Regimens
DRUG
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
NCT06694805
NCT04142047
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07428330