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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Community Programs for Clinical Research on AIDS |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00385632 |
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.
Condition | Intervention |
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HIV Infections |
Drug: Antiretroviral Regimens |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Quality of Life and Healthcare Utilization Substudy |
Enrollment: | 1224 |
Study Start Date: | January 2002 |
Estimated Study Completion Date: | March 2009 |
Primary Completion Date: | January 2006 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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1
Participants following 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
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Drug: Antiretroviral Regimens
Various antiretroviral therapy combinations already being administered to participants
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2
Participants following a viral suppression (VS) regimen in which ART was continued to keep viral loads as low as possible, regardless of CD4 cell count
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Drug: Antiretroviral Regimens
Various antiretroviral therapy combinations already being administered to participants
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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:
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.
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Participants using conservation and viral suppression ART treatment regimens
Inclusion Criteria:
United States, California | |
Kaiser Permanente-Fremont/Hayward Medical Centers | |
Fremont, California, United States, 94538 | |
Office of Martin Mass | |
San Francisco, California, United States, 94110 | |
Office of Toby Dyner | |
San Francisco, California, United States, 94110 | |
St. Mary's Medical Center HIV Center | |
San Francisco, California, United States, 94110 |
Study Chair: | Wafaa El-Sadr, MD, MPH | Harlem AIDS Treatment Group, Harlem Hospital Center |
Study Chair: | James Neaton, PhD | CPCRA Statistical and Data Management Center/CCBR |
Responsible Party: | DAIDS ( Rona Siskind ) |
Study ID Numbers: | CPCRA 065A, SMART |
Study First Received: | October 6, 2006 |
Last Updated: | May 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00385632 |
Health Authority: | United States: Federal Government |
Treatment Experienced |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Quality of Life Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |