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

This study has been completed.
Sponsor:
Collaborator:
Community Programs for Clinical Research on AIDS
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00385632
First received: October 6, 2006
Last updated: April 16, 2014
Last verified: April 2014

October 6, 2006
April 16, 2014
January 2002
November 2008   (final data collection date for 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 ] [ Designated as safety issue: Yes ]
  • Self-reported healthcare utilization [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Recorded medications used by participants [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Cost of treating HIV/AIDS [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00385632 on ClinicalTrials.gov Archive Site
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Effects of Two Anti-HIV Drug Regimens on Quality of Life and Health Care Use Among SMART Study Participants
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Participants using conservation and viral suppression ART treatment regimens

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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1224
November 2008
November 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Coenrollment in the SMART study
  • Parent or guardian willing to provide informed consent, if applicable
Both
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00385632
CPCRA 065A, SMART, 10112
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Community Programs for Clinical Research on AIDS
Study Chair: Wafaa El-Sadr, MD, MPH Harlem AIDS Treatment Group, Harlem Hospital Center
Study Chair: James Neaton, PhD CPCRA Statistical and Data Management Center/CCBR
National Institute of Allergy and Infectious Diseases (NIAID)
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP