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HIV InfectionsNCT00385632

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

An observational study of HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 67 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 13 years and older
Conditions the study is for
HIV Infections
What is being tested?
Antiretroviral Regimens
How many people
1,224 participants
Where
67 sitesUnited States
Study dates
Jan 2002to Nov 2008
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Participants using conservation and viral suppression ART treatment regimens

Who may be able to join

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

Who cannot join

None listed.

Trial locations and contacts

67 sites in 1 country.

67 sites in 1 country

United States67 sites

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

    Baton Rouge, Louisiana, 70805

  • James Osterberger, MD (Private Med. Practice) CRS

    Baton Rouge, Louisiana, 70808-4390

  • CRI-Boston CRS

    Boston, Massachusetts, 02115

  • Beacon Clinic at Boulder CRS

    Boulder, Colorado, 80501-4507

  • Klein & Slotten Medical Associates CRS

    Chicago, Illinois, 60610

  • Cook County Hosp. CORE Ctr.

    Chicago, Illinois, 60612

  • Univ. of Illinois Family Ctr. for Infectious Disease CRS

    Chicago, Illinois, 60612

  • Univ. of Chicago Hosps. CRS

    Chicago, Illinois, 60637

  • Lakeshore Infectious Disease Associates CRS

    Chicago, Illinois, 60657

  • North Side Family Medicine CRS

    Chicago, Illinois, 60657

  • Northwestern Memorial Physicians Group CRS

    Chicago, Illinois, 60657

  • Atlanta VAMC CRS

    Decatur, Georgia, 30033

  • Denver Infectious Diseases Consultants CRS

    Denver, Colorado, 80204-4507

  • Kaiser Permanente of Denver CRS

    Denver, Colorado, 80204-4507

  • Univ. of Colorado Health Science Ctr. CRS

    Denver, Colorado, 80204-4507

  • Denver Public Health CRS

    Denver, Colorado, 80204

  • Eastside Family Health Ctr. CRS

    Denver, Colorado, 80205

  • Denver VAMC CRS

    Denver, Colorado, 80220

  • Denver Public Health CRS - INSIGHT

    Denver, Colorado

  • Henry Ford Hosp. CRS

    Detroit, Michigan, 48202

  • Univ. of Connecticut Health Ctr. CRS

    Farmington, Connecticut, 06030

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

    Fresno, California, 93702

  • Georgetown Wellness Clinic

    Georgetown, Delaware, 19947

  • ID Care Inc. - Hillsborough CRS

    Hillsborough, New Jersey, 08844

  • Legacy Community Health Services, Inc. CRS

    Houston, Texas, 77006

  • Baylor College of Medicine, Thomas St. Clinic CRS

    Houston, Texas, 77030

  • Houston AIDS Research Team CRS

    Houston, Texas, 77030

  • Michael E. DeBakey VAMC CRS

    Houston, Texas, 77030

  • Thomas Street Clinic CRS

    Houston, Texas, 77030

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

    Houston, Texas, 77030

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

    Jackson, Michigan, 39216-4505

  • Michigan State Univ., Infectious Disease Clinic CRS

    Lansing, Michigan, 48910

  • Miami VAMC CRS

    Miami, Florida, 33125

  • Dr. M. Estes Med. Practice CRS

    Mill Valley, California, 94941-3013

  • Mt. Clemens Gen. Hosp. CRS

    Mount Clemens, Michigan, 48043

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

    New Haven, Connecticut, 06510

  • Hosp. of St. Raphael CRS

    New Haven, Connecticut, 06511

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

    New Orleans, Louisiana, 70112

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

    New Orleans, Louisiana, 70112

  • New Orleans VAMC CRS

    New Orleans, Louisiana, 70146

  • St. Vincent Hosp. & Med. Ctr. CRS

    New York, New York, 10011

  • Metropolitan Hosp. Ctr. CRS

    New York, New York, 10029

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

    New York, New York, 10037-1802

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

    New York, New York, 10037

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

    Newark, New Jersey, 07103

  • New Jersey Community Research Initiative, Jeffrey Bomser Clinic CRS

    Newark, New Jersey, 07103

  • Dr. Robert Scott Med. Practice CRS

    Oakland, California, 94609

  • East Bay AIDS Ctr. CRS

    Oakland, California, 94609

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

    Paterson, New Jersey, 07503

  • Raritan Bay Med. Ctr., Perth Amboy Division CRS

    Perth Amboy, New Jersey, 08861

  • ID Care - Randolph CRS

    Randolph Township, New Jersey, 07869

  • South Texas Veterans Health Care System, Immunosuppression Clinic CRS

    San Antonio, Texas, 78229

  • Dr. Shawn Hassler Med. Practice CRS

    San Francisco, California, 94102

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

    San Francisco, California, 94110

  • Dr. Virginia Cafaro Med. Practice CRS

    San Francisco, California, 94114-1010

  • Dr. William Owen Med. Practice CRS

    San Francisco, California, 94114-1010

  • Castro-Mission Health Ctr. CRS

    San Francisco, California, 94114

  • San Francisco VAMC, Infectious Diseases Clinic CRS

    San Francisco, California, 94121

  • UCSF PHP, Gen. Internal Medicine Practice CRS

    San Francisco, California, 94143

  • Providence Hosp,-Newland Med. Assoc Inc CRS

    Southfield, Michigan, 48075

  • CRI-Springfield CRS

    Springfield, Massachusetts, 01107

  • Jacobi Med. Ctr., Ambulatory Care Pavillion CRS

    The Bronx, New York, 10461

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

    Union, New Jersey, 07083

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

    Washington D.C., District of Columbia, 20422

  • VAMC West Haven CRS

    West Haven, Connecticut, 06516

  • Western Infectious Disease Consultants CRS

    Wheat Ridge, Colorado, 80033

  • Christiana Care Health Services HIV Program CRS

    Wilmington, Delaware, 19801

Other trials in United States

About this study

Official title: Quality of Life and Healthcare Utilization Substudy

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.

Read the 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.

Conditions
HIV Infections
Being tested
Antiretroviral Regimens
Keywords
Treatment Experienced
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Antiretroviral RegimensDrug

    Various antiretroviral therapy combinations already being administered to participants

Study groups in NCT00385632
Study groupRoleWhat they receive
1Participants 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
Receives: Drug: Antiretroviral Regimens
2Participants following a viral suppression (VS) regimen in which ART was continued to keep viral loads as low as possible, regardless of CD4 cell count
Receives: Drug: Antiretroviral Regimens

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quality of life as assessed by self-administered questionnaires, a symptom severity survey, and an assessment of body appearance

    Measured: Throughout study

  2. Self-reported healthcare utilization

    Measured: Throughout study

  3. Recorded medications used by participants

    Measured: Throughout study

  4. Cost of treating HIV/AIDS

    Measured: Throughout study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Oct 2006 (estimated)
  2. Study startJan 2002
  3. Primary completionNov 2008
  4. Study completionNov 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,224 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00385632
Sponsor's protocol ID
CPCRA 065A
Other IDs
SMART, 10112
Status last verified
Apr 2014
First submitted
6 Oct 2006
Last updated
21 Apr 2014
Results posted
No

Publications

  • 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.

    PubMed 15344307

  • 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.

    PubMed 16800165

  • 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.

    PubMed 16900275

  • 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.

    PubMed 16036256

Questions about this trial

What is this clinical trial studying?

An observational study of HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 67 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 67 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of life as assessed by self-administered questionnaires, a symptom severity survey, and an assessment of body appearance (time frame: Throughout study). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00385632, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2014.

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