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)
VAMC West Haven CRS
🇺🇸West Haven, Connecticut, United States
Univ. of Connecticut Health Ctr. CRS
🇺🇸Farmington, Connecticut, United States
Cathedral Healthcare System, St. Michael's Med. Ctr. CRS
🇺🇸Newark, New Jersey, United States
Christiana Care Health Services HIV Program CRS
🇺🇸Wilmington, Delaware, United States
CRI-Springfield CRS
🇺🇸Springfield, Massachusetts, United States
James Osterberger, MD (Private Med. Practice) CRS
🇺🇸Baton Rouge, Louisiana, United States
Earl K. Long Med. Ctr., LSU - Mid City EIC Clinic CRS
🇺🇸Baton Rouge, Louisiana, United States
Washington DC VAMC, Washington Regional AIDS Program, Infectious Diseases CRS
🇺🇸Washington, District of Columbia, United States
Providence Hosp,-Newland Med. Assoc Inc CRS
🇺🇸Southfield, Michigan, United States
Mt. Clemens Gen. Hosp. CRS
🇺🇸Mount Clemens, Michigan, United States
ID Care Inc. - Hillsborough CRS
🇺🇸Hillsborough, New Jersey, United States
St. Joseph's Hosp. & Med. Ctr. of New Jersey CRS
🇺🇸Paterson, New Jersey, United States
New Jersey Community Research Initiative, Jeffrey Bomser Clinic CRS
🇺🇸Newark, New Jersey, United States
East Bay AIDS Ctr. CRS
🇺🇸Oakland, California, United States
Atlanta VAMC CRS
🇺🇸Decatur, Georgia, United States
Metropolitan Hosp. Ctr. CRS
🇺🇸New York, New York, United States
Harlem Hospital Ctr./Columbia University CRS (Gordin CTU)
🇺🇸New York, New York, United States
Harlem Hosp. Ctr., Outpatient Clinics (New York) CRS
🇺🇸New York, New York, United States
Western Infectious Disease Consultants CRS
🇺🇸Wheat Ridge, Colorado, United States
St. Vincent Hosp. & Med. Ctr. CRS
🇺🇸New York, New York, 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. William Owen Med. Practice CRS
🇺🇸San Francisco, California, United States
Dr. Virginia Cafaro 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
UCSF PHP, Gen. Internal Medicine Practice CRS
🇺🇸San Francisco, California, United States
Miami VAMC CRS
🇺🇸Miami, Florida, United States
Klein & Slotten Medical Associates CRS
🇺🇸Chicago, Illinois, United States
Cook County Hosp. CORE Ctr.
🇺🇸Chicago, Illinois, United States
Univ. of Illinois Family Ctr. for Infectious Disease CRS
🇺🇸Chicago, Illinois, United States
Univ. of Chicago Hosps. CRS
🇺🇸Chicago, Illinois, United States
Lakeshore Infectious Disease Associates CRS
🇺🇸Chicago, Illinois, United States
North Side Family Medicine CRS
🇺🇸Chicago, Illinois, United States
Northwestern Memorial Physicians Group CRS
🇺🇸Chicago, Illinois, United States
CRI-Boston CRS
🇺🇸Boston, Massachusetts, United States
Legacy Community Health Services, Inc. CRS
🇺🇸Houston, Texas, United States
Baylor College of Medicine, Thomas St. Clinic CRS
🇺🇸Houston, Texas, United States
Houston AIDS Research Team CRS
🇺🇸Houston, Texas, United States
Univ. Clinical Research Ctr., Memorial Hermann Hosp. CRS
🇺🇸Houston, Texas, United States
South Texas Veterans Health Care System, Immunosuppression Clinic CRS
🇺🇸San Antonio, Texas, United States
Beacon Clinic at Boulder CRS
🇺🇸Boulder, Colorado, United States
Denver Public Health CRS
🇺🇸Denver, Colorado, United States
Kaiser Permanente of Denver CRS
🇺🇸Denver, Colorado, United States
Eastside Family Health Ctr. CRS
🇺🇸Denver, Colorado, United States
Henry Ford Hosp. CRS
🇺🇸Detroit, Michigan, United States
Denver Infectious Diseases Consultants CRS
🇺🇸Denver, Colorado, United States
Univ. of Colorado Health Science Ctr. CRS
🇺🇸Denver, Colorado, United States
Denver VAMC CRS
🇺🇸Denver, Colorado, United States
Denver Public Health CRS - INSIGHT
🇺🇸Denver, Colorado, United States
Hosp. of St. Raphael CRS
🇺🇸New Haven, Connecticut, United States
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
Univ. of Mississippi Med. Ctr., Div. of Infectious Diseases CRS
🇺🇸Jackson, Michigan, United States
Michigan State Univ., Infectious Disease Clinic CRS
🇺🇸Lansing, Michigan, United States
ID Care - Randolph CRS
🇺🇸Randolph, New Jersey, United States
Raritan Bay Med. Ctr., Perth Amboy Division CRS
🇺🇸Perth Amboy, New Jersey, United States
Infectious Disease Specialists of N.J., North Jersey Community Research Initiative CRS
🇺🇸Union,, New Jersey, United States
Michael E. DeBakey VAMC CRS
🇺🇸Houston, Texas, United States
Thomas Street Clinic CRS
🇺🇸Houston, Texas, United States
New Orleans VAMC CRS
🇺🇸New Orleans, Louisiana, United States
Yale Univ. School of Medicine, NE ProACT - New Haven CRS
🇺🇸New Haven, Connecticut, United States
Med. Ctr. of Louisiana at New Orleans, HIV Outpatient Clinics CRS
🇺🇸New Orleans, Louisiana, United States
Tulane University Health Sciences Center, Louisiana Community AIDS Research Program(LaCARP) CRS
🇺🇸New Orleans, Louisiana, United States
Jacobi Med. Ctr., Ambulatory Care Pavillion CRS
🇺🇸Bronx, New York, United States
Georgetown Wellness Clinic
🇺🇸Georgetown, Delaware, United States