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A Study of Health-Related Quality of Life in HIV-Infected Patients Undergoing Structured Treatment Interruptions of Highly Active Antiretroviral Therapy Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on A Study of Health-Related Quality of Life in HIV-Infected Patients Undergoing Structured Treatment Interruptions of Highly Active Antiretroviral Therapy conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. A Study of Health-Related Quality of Life in HIV-Infected Patients Undergoing Structured Treatment Interruptions of Highly Active Antiretroviral Therapy Clinical research trials and A Study of Health-Related Quality of Life in HIV-Infected Patients Undergoing Structured Treatment Interruptions of Highly Active Antiretroviral Therapy healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including A Study of Health-Related Quality of Life in HIV-Infected Patients Undergoing Structured Treatment Interruptions of Highly Active Antiretroviral Therapy. A Study of Health-Related Quality of Life in HIV-Infected Patients Undergoing Structured Treatment Interruptions of Highly Active Antiretroviral Therapy Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a A Study of Health-Related Quality of Life in HIV-Infected Patients Undergoing Structured Treatment Interruptions of Highly Active Antiretroviral Therapy clinical trial. Participants typically obtain the most effective healthcare available for their A Study of Health-Related Quality of Life in HIV-Infected Patients Undergoing Structured Treatment Interruptions of Highly Active Antiretroviral Therapy condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Study of Health-Related Quality of Life in HIV-Infected Patients Undergoing Structured Treatment Interruptions of Highly Active Antiretroviral Therapy  A Study of Health-Related Quality of Life in HIV-Infected Patients Undergoing Structured Treatment Interruptions of Highly Active Antiretroviral Therapy
A Study of Health-Related Quality of Life in HIV-Infected Patients Undergoing Structured Treatment Interruptions of Highly Active Antiretroviral Therapy
For Condition: HIV Infection
Status: Completed
Sponsor(s): Warren G Magnuson Clinical Center (CC) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: 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.
Total Enrollment: 70
Location and Contact Information:
Warren G. Magnuson Clinical Center (CC)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 000046; 00-CC-0046
Study Start Date: December 22, 1999
Record last reviewed: February 20, 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001948
Other Hiv Infection Studies:
1. Adefovir Dipivoxil to Treat Hepatitis B in HIV-Infected Patients
2. Evaluation of the Significance of Anti-HIV Antibody in Asymptomatic Blood Donors
3. Long-Term Survival with HIV: Psychological and Behavioral Factors Associated with the Transition from Adolescence to Young Adulthood
4. Interleukin-2 Therapy for HIV Infection - Supplemental Procedures
5. Pharmacodynamics of Intermittent IL-2 Infusions in HIV Seropositive Patients
Related Studies:
Other HIV Infection Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
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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