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

NCT00385632 | Completed

• 3 other identifiers: CPCRA 065ASMART10112
• Study Type: observational
• Target: 1,224
• Locations: 1 country
• Sites: 67

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.

Conditions

HIV Infections

Keywords

Treatment Experienced

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

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

Drug: Antiretroviral Regimens

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

Drug: Antiretroviral Regimens

Interventions

Antiretroviral Regimens DRUG

Various antiretroviral therapy combinations already being administered to participants

1; 2

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants using conservation and viral suppression ART treatment regimens

You may qualify if:

• Coenrollment in the SMART study
• Parent or guardian willing to provide informed consent, if applicable

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Community Programs for Clinical Research on AIDS: collaborator

Study Sites (67)

UCSF, Fresno, School of Medicine, Dept. of Internal Medicine CRS

Fresno, California, 93702, United States

Location

Dr. M. Estes Med. Practice CRS

Mill Valley, California, 94941-3013, United States

Location

Dr. Robert Scott Med. Practice CRS

Oakland, California, 94609, United States

Location

East Bay AIDS Ctr. CRS

Oakland, California, 94609, United States

Location

Dr. Shawn Hassler Med. Practice CRS

San Francisco, California, 94102, United States

Location

Positive Health Program Clinic (San Francisco Gen. Hosp.) CRS

San Francisco, California, 94110, United States

Location

Dr. Virginia Cafaro Med. Practice CRS

San Francisco, California, 94114-1010, United States

Location

Dr. William Owen Med. Practice CRS

San Francisco, California, 94114-1010, United States

Location

Castro-Mission Health Ctr. CRS

San Francisco, California, 94114, United States

Location

San Francisco VAMC, Infectious Diseases Clinic CRS

San Francisco, California, 94121, United States

Location

UCSF PHP, Gen. Internal Medicine Practice CRS

San Francisco, California, 94143, United States

Location

Beacon Clinic at Boulder CRS

Boulder, Colorado, 80501-4507, United States

Location

Denver Infectious Diseases Consultants CRS

Denver, Colorado, 80204-4507, United States

Location

Kaiser Permanente of Denver CRS

Denver, Colorado, 80204-4507, United States

Location

Univ. of Colorado Health Science Ctr. CRS

Denver, Colorado, 80204-4507, United States

Location

Denver Public Health CRS

Denver, Colorado, 80204, United States

Location

Eastside Family Health Ctr. CRS

Denver, Colorado, 80205, United States

Location

Denver VAMC CRS

Denver, Colorado, 80220, United States

Location

Denver Public Health CRS - INSIGHT

Denver, Colorado, United States

Location

Western Infectious Disease Consultants CRS

Wheat Ridge, Colorado, 80033, United States

Location

Univ. of Connecticut Health Ctr. CRS

Farmington, Connecticut, 06030, United States

Location

Yale Univ. School of Medicine, NE ProACT - New Haven CRS

New Haven, Connecticut, 06510, United States

Location

Hosp. of St. Raphael CRS

New Haven, Connecticut, 06511, United States

Location

VAMC West Haven CRS

West Haven, Connecticut, 06516, United States

Location

Georgetown Wellness Clinic

Georgetown, Delaware, 19947, United States

Location

Christiana Care Health Services HIV Program CRS

Wilmington, Delaware, 19801, United States

Location

Washington DC VAMC, Washington Regional AIDS Program, Infectious Diseases CRS

Washington D.C., District of Columbia, 20422, United States

Location

Miami VAMC CRS

Miami, Florida, 33125, United States

Location

Atlanta VAMC CRS

Decatur, Georgia, 30033, United States

Location

Klein & Slotten Medical Associates CRS

Chicago, Illinois, 60610, United States

Location

Cook County Hosp. CORE Ctr.

Chicago, Illinois, 60612, United States

Location

Univ. of Illinois Family Ctr. for Infectious Disease CRS

Chicago, Illinois, 60612, United States

Location

Univ. of Chicago Hosps. CRS

Chicago, Illinois, 60637, United States

Location

Lakeshore Infectious Disease Associates CRS

Chicago, Illinois, 60657, United States

Location

North Side Family Medicine CRS

Chicago, Illinois, 60657, United States

Location

Northwestern Memorial Physicians Group CRS

Chicago, Illinois, 60657, United States

Location

Earl K. Long Med. Ctr., LSU - Mid City EIC Clinic CRS

Baton Rouge, Louisiana, 70805, United States

Location

James Osterberger, MD (Private Med. Practice) CRS

Baton Rouge, Louisiana, 70808-4390, United States

Location

Med. Ctr. of Louisiana at New Orleans, HIV Outpatient Clinics CRS

New Orleans, Louisiana, 70112, United States

Location

Tulane University Health Sciences Center, Louisiana Community AIDS Research Program(LaCARP) CRS

New Orleans, Louisiana, 70112, United States

Location

New Orleans VAMC CRS

New Orleans, Louisiana, 70146, United States

Location

CRI-Boston CRS

Boston, Massachusetts, 02115, United States

Location

CRI-Springfield CRS

Springfield, Massachusetts, 01107, United States

Location

Henry Ford Hosp. CRS

Detroit, Michigan, 48202, United States

Location

Univ. of Mississippi Med. Ctr., Div. of Infectious Diseases CRS

Jackson, Michigan, 39216-4505, United States

Location

Michigan State Univ., Infectious Disease Clinic CRS

Lansing, Michigan, 48910, United States

Location

Mt. Clemens Gen. Hosp. CRS

Mount Clemens, Michigan, 48043, United States

Location

Providence Hosp,-Newland Med. Assoc Inc CRS

Southfield, Michigan, 48075, United States

Location

ID Care Inc. - Hillsborough CRS

Hillsborough, New Jersey, 08844, United States

Location

Cathedral Healthcare System, St. Michael's Med. Ctr. CRS

Newark, New Jersey, 07103, United States

Location

New Jersey Community Research Initiative, Jeffrey Bomser Clinic CRS

Newark, New Jersey, 07103, United States

Location

St. Joseph's Hosp. & Med. Ctr. of New Jersey CRS

Paterson, New Jersey, 07503, United States

Location

Raritan Bay Med. Ctr., Perth Amboy Division CRS

Perth Amboy, New Jersey, 08861, United States

Location

ID Care - Randolph CRS

Randolph Township, New Jersey, 07869, United States

Location

Infectious Disease Specialists of N.J., North Jersey Community Research Initiative CRS

Union, New Jersey, 07083, United States

Location

St. Vincent Hosp. & Med. Ctr. CRS

New York, New York, 10011, United States

Location

Metropolitan Hosp. Ctr. CRS

New York, New York, 10029, United States

Location

Harlem Hospital Ctr./Columbia University CRS (Gordin CTU)

New York, New York, 10037-1802, United States

Location

Harlem Hosp. Ctr., Outpatient Clinics (New York) CRS

New York, New York, 10037, United States

Location

Jacobi Med. Ctr., Ambulatory Care Pavillion CRS

The Bronx, New York, 10461, United States

Location

Legacy Community Health Services, Inc. CRS

Houston, Texas, 77006, United States

Location

Baylor College of Medicine, Thomas St. Clinic CRS

Houston, Texas, 77030, United States

Location

Houston AIDS Research Team CRS

Houston, Texas, 77030, United States

Location

Michael E. DeBakey VAMC CRS

Houston, Texas, 77030, United States

Location

Thomas Street Clinic CRS

Houston, Texas, 77030, United States

Location

Univ. Clinical Research Ctr., Memorial Hermann Hosp. CRS

Houston, Texas, 77030, United States

Location

South Texas Veterans Health Care System, Immunosuppression Clinic CRS

San Antonio, Texas, 78229, United States

Location

Related 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. doi: 10.2165/00019053-200018040-00007.

  PMID: 15344307 BACKGROUND

• 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.

  PMID: 16800165 BACKGROUND

• 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.

  PMID: 16900275 BACKGROUND

• 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.

  PMID: 16036256 BACKGROUND

Related Links

• Click here for more information on CPCRA 065

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Wafaa El-Sadr, MD, MPH

  Harlem AIDS Treatment Group, Harlem Hospital Center

  STUDY CHAIR

• James Neaton, PhD

  CPCRA Statistical and Data Management Center/CCBR

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2006
• First Posted: October 11, 2006
• Study Start: January 1, 2002
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: April 21, 2014

Record last verified: 2014-04

Locations

US (67)