Effects of Two Anti-HIV Drug Regimens on Quality of Life and Health Care Use Among SMART Study Participants
- Conditions
- HIV Infections
- Interventions
- Drug: Antiretroviral Regimens
- Registration Number
- NCT00385632
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1224
- Coenrollment in the SMART study
- Parent or guardian willing to provide informed consent, if applicable
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 1 Antiretroviral Regimens 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 2 Antiretroviral Regimens 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
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (67)
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
Scroll for more (57 remaining)UCSF, Fresno, School of Medicine, Dept. of Internal Medicine CRS🇺🇸Fresno, California, United States