Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001948
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2000-01-18
Brief Title:
A Study of Health-Related Quality of Life in HIV-Infected Patients Undergoing Structured Treatment Interruptions of Highly Active Antiretroviral Therapy
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Study of Health-Related Quality of Life in HIV-Infected Patients Undergoing Structured Treatment Interruptions of Highly Active Antiretroviral Therapy
Status:
COMPLETED
Status Verified Date:
2002-02
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:
This study will examine and compare the health-related quality of life and degree of symptom discomfort in two groups of patients receiving intensive drug therapy for HIV infection One group will receive continuous treatment over the entire 88-week study period the other will have interruptions in therapy over the same time period
Patients enrolled in the National Institute of Allergy and Infectious Diseases trial Immunologic and Virologic Studies of Intermittent versus Continuous HAART highly active antiretroviral therapy in the Treatment of HIV Disease may participate in this study At periodic intervals for a total of 7 times during the 88-week trial this companion study will require participants in both the interrupted and the continuous therapy groups to complete the following two questionnaires
1 MOS-HIV Health Survey - The patient provides a self-assessment of his or her physical and emotional well being Survey questions are related to the ability to perform work and daily living activities mood and state of mind limitations on social activities ability to concentrate energy level pain level general quality of life etc
2 Symptom Distress Scale - The patient rates the degree of symptom distress by ranking from 1 to 5 his or her agreement with statements about various physical and emotional factors including appetite nausea breathing cough pain insomnia fatigue bowel problems concentration appearance and outlook
Understanding the impact of HIV treatments on health-related quality of life and symptom distress may provide information helpful in evaluating new treatment approaches
Patients enrolled in the National Institute of Allergy and Infectious Diseases trial Immunologic and Virologic Studies of Intermittent versus Continuous HAART highly active antiretroviral therapy in the Treatment of HIV Disease may participate in this study At periodic intervals for a total of 7 times during the 88-week trial this companion study will require participants in both the interrupted and the continuous therapy groups to complete the following two questionnaires
1 MOS-HIV Health Survey - The patient provides a self-assessment of his or her physical and emotional well being Survey questions are related to the ability to perform work and daily living activities mood and state of mind limitations on social activities ability to concentrate energy level pain level general quality of life etc
2 Symptom Distress Scale - The patient rates the degree of symptom distress by ranking from 1 to 5 his or her agreement with statements about various physical and emotional factors including appetite nausea breathing cough pain insomnia fatigue bowel problems concentration appearance and outlook
Understanding the impact of HIV treatments on health-related quality of life and symptom distress may provide information helpful in evaluating new treatment approaches
Detailed Description:
Because of multi-drug regimens known as highly active antiretroviral therapy HAART HIV infection can now be considered a chronic manageable disease for many people in the United States However these therapies come with complex medication administration regimens and numerous side effects and distressing symptoms which may impact significantly on a persons health-related quality of life HR-QOL The purpose of this study is to evaluate the HR-QOL and symptom distress the degree of discomfort from specific symptoms in individuals participating in the NIAID protocol Immunologic and virologic studies of intermittent versus continuous HAART in the treatment of HIV disease In that study thirty-five subjects will be randomly assigned to receive continuous HAART therapy and 35 subjects will receive interrupted therapy In this a companion study HR-QOL and symptom distress will be measured at seven time points during the 88 weeks of the protocol Data will be analyzed using repeated measures and multivariate statistical tests
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 |
|---|---|---|---|
| 00-CC-0046 | None | None | None |