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:
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.
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 person's
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.
Patients must be HIV seropositive man or women of at least 18 years of age who are
enrolled in the NIAID clinical trial, "Immunologic and virologic studies of intermittent
versus continuous HAART in the treatment of HIV disease".
Patients must be able to read and understand standard English.