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NCT00385632 Clinical Trial

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

HIV Infections Clinical Trial

Official title:
Quality of Life and Healthcare Utilization Substudy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00385632
Other study ID # CPCRA 065A
Secondary ID SMART10112
Status Completed
Phase N/A
First received October 6, 2006
Last updated April 16, 2014
Start date January 2002
Est. completion date November 2008

Study information
Verified date April 2014
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial 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.

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 information / eligibility
Status Completed
Enrollment 1224
Est. completion date November 2008
Est. primary completion date November 2008
Accepts healthy volunteers No
Gender Both
Age group 13 Years and older
Eligibility Inclusion Criteria:

- Coenrollment in the SMART study

- Parent or guardian willing to provide informed consent, if applicable

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• Antiretroviral Regimens
Various antiretroviral therapy combinations already being administered to participants

Locations
Country Name City State
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 CRI-Boston CRS Boston Massachusetts
United States Beacon Clinic at Boulder CRS Boulder Colorado
United States Jacobi Med. Ctr., Ambulatory Care Pavillion CRS Bronx New York
United States Cook County Hosp. CORE Ctr. Chicago Illinois
United States Klein & Slotten Medical Associates 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 Univ. of Chicago Hosps. CRS Chicago Illinois
United States Univ. of Illinois Family Ctr. for Infectious Disease CRS Chicago Illinois
United States Atlanta VAMC CRS Decatur Georgia
United States Denver Infectious Diseases Consultants CRS Denver Colorado
United States Denver Public Health CRS Denver Colorado
United States Denver Public Health CRS - INSIGHT Denver Colorado
United States Denver VAMC CRS Denver Colorado
United States Eastside Family Health Ctr. 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 Henry Ford Hosp. CRS Detroit Michigan
United States Univ. of Connecticut Health Ctr. CRS Farmington Connecticut
United States UCSF, Fresno, School of Medicine, Dept. of Internal Medicine CRS Fresno California
United States Georgetown Wellness Clinic Georgetown Delaware
United States ID Care Inc. - Hillsborough CRS Hillsborough New Jersey
United States Baylor College of Medicine, Thomas St. Clinic CRS Houston Texas
United States Houston AIDS Research Team CRS Houston Texas
United States Legacy Community Health Services, Inc. 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 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 Miami VAMC CRS Miami Florida
United States Dr. M. Estes Med. Practice CRS Mill Valley California
United States Mt. Clemens Gen. Hosp. CRS Mount Clemens Michigan
United States Hosp. of St. Raphael CRS New Haven Connecticut
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 New Orleans VAMC CRS New Orleans Louisiana
United States Tulane University Health Sciences Center, Louisiana Community AIDS Research Program(LaCARP) CRS New Orleans Louisiana
United States Harlem Hosp. Ctr., Outpatient Clinics (New York) CRS New York New York
United States Harlem Hospital Ctr./Columbia University CRS (Gordin CTU) New York New York
United States Metropolitan Hosp. Ctr. CRS New York New York
United States St. Vincent Hosp. & Med. Ctr. CRS New York New York
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 Dr. Robert Scott Med. Practice CRS Oakland California
United States East Bay AIDS Ctr. CRS Oakland California
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 New Jersey
United States South Texas Veterans Health Care System, Immunosuppression Clinic CRS San Antonio Texas
United States Castro-Mission Health Ctr. CRS San Francisco California
United States Dr. Shawn Hassler Med. Practice 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 Positive Health Program Clinic (San Francisco Gen. Hosp.) 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 Providence Hosp,-Newland Med. Assoc Inc CRS Southfield Michigan
United States CRI-Springfield CRS Springfield Massachusetts
United States Infectious Disease Specialists of N.J., North Jersey Community Research Initiative CRS Union, New Jersey
United States Washington DC VAMC, Washington Regional AIDS Program, Infectious Diseases CRS Washington District of Columbia
United States VAMC West Haven CRS West Haven Connecticut
United States Western Infectious Disease Consultants CRS Wheat Ridge Colorado
United States Christiana Care Health Services HIV Program CRS Wilmington Delaware

Sponsors (2)
Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) Community Programs for Clinical Research on AIDS

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Quality of life as assessed by self-administered questionnaires, a symptom severity survey, and an assessment of body appearance Throughout study Yes
Primary Self-reported healthcare utilization Throughout study No
Primary Recorded medications used by participants Throughout study No
Primary Cost of treating HIV/AIDS Throughout study No
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