Effects of Two Anti-HIV Drug Regimens on Quality of Life and Health Care Use Among SMART Study Participants
NCT ID: NCT00385632
Last Updated: 2014-04-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
1224 participants
OBSERVATIONAL
2002-01-31
2008-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effects of Anti-HIV Therapy on Nervous System Function
NCT00432003
A Study of the Long-Term Outcomes of HIV-Positive Patients
NCT00000932
A Study of Health-Related Quality of Life in HIV-Infected Patients Undergoing Structured Treatment Interruptions of Highly Active Antiretroviral Therapy
NCT00001948
Suppression of HIV 1 RNA in People Living With HIV
NCT02363387
HIV Expression in Patients With Low Viral Load on Highly Active Antiretroviral Therapy (HAART)
NCT00043641
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
Antiretroviral Regimens
Various antiretroviral therapy combinations already being administered to participants
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
Antiretroviral Regimens
Various antiretroviral therapy combinations already being administered to participants
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Antiretroviral Regimens
Various antiretroviral therapy combinations already being administered to participants
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Parent or guardian willing to provide informed consent, if applicable
13 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Community Programs for Clinical Research on AIDS
NETWORK
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Wafaa El-Sadr, MD, MPH
Role: STUDY_CHAIR
Harlem AIDS Treatment Group, Harlem Hospital Center
James Neaton, PhD
Role: STUDY_CHAIR
CPCRA Statistical and Data Management Center/CCBR
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
UCSF PHP, Gen. Internal Medicine Practice CRS
San Francisco, California, United States
Beacon Clinic at Boulder CRS
Boulder, Colorado, United States
Denver Infectious Diseases Consultants CRS
Denver, Colorado, United States
Kaiser Permanente of Denver CRS
Denver, Colorado, United States
Univ. of Colorado Health Science Ctr. CRS
Denver, Colorado, United States
Denver Public Health CRS
Denver, Colorado, United States
Eastside Family Health Ctr. CRS
Denver, Colorado, United States
Denver VAMC CRS
Denver, Colorado, United States
Denver Public Health CRS - INSIGHT
Denver, Colorado, United States
Western Infectious Disease Consultants CRS
Wheat Ridge, Colorado, United States
Univ. of Connecticut Health Ctr. CRS
Farmington, Connecticut, United States
Yale Univ. School of Medicine, NE ProACT - New Haven CRS
New Haven, Connecticut, United States
Hosp. of St. Raphael CRS
New Haven, Connecticut, United States
VAMC West Haven CRS
West Haven, Connecticut, United States
Georgetown Wellness Clinic
Georgetown, Delaware, United States
Christiana Care Health Services HIV Program CRS
Wilmington, Delaware, United States
Washington DC VAMC, Washington Regional AIDS Program, Infectious Diseases CRS
Washington D.C., District of Columbia, United States
Miami VAMC CRS
Miami, Florida, United States
Atlanta VAMC CRS
Decatur, Georgia, 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
Earl K. Long Med. Ctr., LSU - Mid City EIC Clinic CRS
Baton Rouge, Louisiana, United States
James Osterberger, MD (Private Med. Practice) CRS
Baton Rouge, Louisiana, 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
New Orleans VAMC CRS
New Orleans, Louisiana, United States
CRI-Boston CRS
Boston, Massachusetts, United States
CRI-Springfield CRS
Springfield, Massachusetts, United States
Henry Ford Hosp. CRS
Detroit, Michigan, 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
Mt. Clemens Gen. Hosp. CRS
Mount Clemens, Michigan, United States
Providence Hosp,-Newland Med. Assoc Inc CRS
Southfield, Michigan, United States
ID Care Inc. - Hillsborough CRS
Hillsborough, New Jersey, United States
Cathedral Healthcare System, St. Michael's Med. Ctr. CRS
Newark, New Jersey, United States
New Jersey Community Research Initiative, Jeffrey Bomser Clinic CRS
Newark, New Jersey, United States
St. Joseph's Hosp. & Med. Ctr. of New Jersey CRS
Paterson, New Jersey, United States
Raritan Bay Med. Ctr., Perth Amboy Division CRS
Perth Amboy, New Jersey, United States
ID Care - Randolph CRS
Randolph Township, New Jersey, United States
Infectious Disease Specialists of N.J., North Jersey Community Research Initiative CRS
Union, New Jersey, United States
St. Vincent Hosp. & Med. Ctr. CRS
New York, New York, 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
Jacobi Med. Ctr., Ambulatory Care Pavillion CRS
The Bronx, New York, 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
Michael E. DeBakey VAMC CRS
Houston, Texas, United States
Thomas Street Clinic 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
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Anis AH, Guh D, Hogg RS, Wang XH, Yip B, Craib KJ, O'Shaughnessy MV, Schechter MT, Montaner JS. The cost effectiveness of antiretroviral regimens for the treatment of HIV/AIDS. Pharmacoeconomics. 2000 Oct;18(4):393-404. doi: 10.2165/00019053-200018040-00007.
Byrne MW, Honig J. Health-related quality of life of HIV-infected children on complex antiretroviral therapy at home. J Assoc Nurses AIDS Care. 2006 Mar-Apr;17(2):27-35. doi: 10.1016/j.jana.2006.01.003.
Liu C, Ostrow D, Detels R, Hu Z, Johnson L, Kingsley L, Jacobson LP. Impacts of HIV infection and HAART use on quality of life. Qual Life Res. 2006 Aug;15(6):941-9. doi: 10.1007/s11136-005-5913-x.
Lowy A, Page J, Jaccard R, Ledergerber B, Somaini B, Weber R, Szucs T. Costs of treatment of Swiss patients with HIV on antiretroviral therapy in hospital-based and general practice-based care: a prospective cohort study. AIDS Care. 2005 Aug;17(6):698-710. doi: 10.1080/09540120412331336689.
Related Links
Access external resources that provide additional context or updates about the study.
Click here for more information on CPCRA 065
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SMART
Identifier Type: -
Identifier Source: secondary_id
10112
Identifier Type: REGISTRY
Identifier Source: secondary_id
CPCRA 065A
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.