Effects of Two Anti-HIV Drug Regimens on Quality of Life and Health Care Use Among SMART Study Participants

Study Overview
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Brief Summary
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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.

Detailed Description
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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: 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.

Official Title
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Quality of Life and Healthcare Utilization Substudy

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Antiretroviral Regimens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Coenrollment in the SMART study Parent or guardian willing to provide informed consent, if applicable

Ages Eligible for Study
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Minimum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>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 | Drug: Antiretroviral Regimens<br>* Various antiretroviral therapy combinations already being administered to participants<br>|
| 2<br>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 | Drug: Antiretroviral Regimens<br>* Various antiretroviral therapy combinations already being administered to participants<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life as assessed by self-administered questionnaires, a symptom severity survey, and an assessment of body appearance |  | Throughout study | 
| Self-reported healthcare utilization |  | Throughout study | 
| Recorded medications used by participants |  | Throughout study | 
| Cost of treating HIV/AIDS |  | Throughout study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Treatment Experienced