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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 Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about 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 website committed 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 health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, 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 permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated 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. Test subjects typically receive the most expert 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, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. 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. Twins Study of Gene Therapy for HIV Infection
2. Differences in Blood Levels of Nevirapine in HIV-infected Patients in Uganda and the United States
3. Immune and Viral Status of HIV-Infected Patients after Stopping Combination Antiretroviral Therapy
4. Screening HIV-Infected Patients for Vaccine Studies
5. Nucleic Acid Amplification Testing (NAT) of Blood Donors for HCV and HIV
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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