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

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ClinicalTrials.gov Identifier: NCT00385632
Recruitment Status : Completed
First Posted : October 11, 2006
Last Update Posted : April 21, 2014
Sponsor:
Collaborator:
Community Programs for Clinical Research on AIDS
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

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.

Condition or disease Intervention/treatment
HIV Infections Drug: Antiretroviral Regimens

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.


Study Type : Observational
Actual Enrollment : 1224 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quality of Life and Healthcare Utilization Substudy
Study Start Date : January 2002
Primary Completion Date : November 2008
Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Group/Cohort Intervention/treatment
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
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
Drug: Antiretroviral Regimens
Various antiretroviral therapy combinations already being administered to participants



Primary Outcome Measures :
  1. Quality of life as assessed by self-administered questionnaires, a symptom severity survey, and an assessment of body appearance [ Time Frame: Throughout study ]
  2. Self-reported healthcare utilization [ Time Frame: Throughout study ]
  3. Recorded medications used by participants [ Time Frame: Throughout study ]
  4. Cost of treating HIV/AIDS [ Time Frame: Throughout study ]


Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants using conservation and viral suppression ART treatment regimens
Criteria

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00385632


  Show 67 Study Locations
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Community Programs for Clinical Research on AIDS
Investigators
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

Additional Information:
Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00385632     History of Changes
Other Study ID Numbers: CPCRA 065A
SMART
10112 ( Registry Identifier: DAIDS-ES )
First Posted: October 11, 2006    Key Record Dates
Last Update Posted: April 21, 2014
Last Verified: April 2014

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases