A Study of Health-Related Quality of Life in HIV-Infected Patients Undergoing Structured Treatment Interruptions of Highly Active Antiretroviral Therapy
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|ClinicalTrials.gov Identifier: NCT00001948|
Recruitment Status : Completed
First Posted : January 19, 2000
Last Update Posted : March 4, 2008
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 Disease's 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:
- 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.
- 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.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||70 participants|
|Official Title:||A Study of Health-Related Quality of Life in HIV-Infected Patients Undergoing Structured Treatment Interruptions of Highly Active Antiretroviral Therapy|
|Study Start Date :||December 1999|
|Estimated Study Completion Date :||February 2002|
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): NCT00001948
|United States, Maryland|
|Warren G. Magnuson Clinical Center (CC)|
|Bethesda, Maryland, United States, 20892|