Ignite Creation Date:
2024-05-05 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00385632
Status:
COMPLETED
Last Update Posted:
2014-04-21
First Post:
2006-10-06
Brief Title:
Effects of Two Anti-HIV Drug Regimens on Quality of Life and Health Care Use Among SMART Study Participants
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Quality of Life and Healthcare Utilization Substudy
Status:
COMPLETED
Status Verified Date:
2014-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 cellsmm3 initiated until CD4 cell count was at least 350 cellsmm3 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
Group 1 participants followed a drug conservation DC regimen in which ART was stopped or deferred until CD4 cell count dropped below 250 cellsmm3 initiated until CD4 cell count was at least 350 cellsmm3 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 10112 | REGISTRY | DAIDS-ES | None |
| SMART | None | None | None |