A Study of Health-Related Quality of Life in HIV-Infected Patients Undergoing Structured Treatment Interruptions of Highly Active Antiretroviral Therapy
|First Received Date ICMJE||January 18, 2000|
|Last Updated Date||March 3, 2008|
|Start Date ICMJE||December 1999|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00001948 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||A Study of Health-Related Quality of Life in HIV-Infected Patients Undergoing Structured Treatment Interruptions of Highly Active Antiretroviral Therapy|
|Official Title ICMJE||A Study of Health-Related Quality of Life in HIV-Infected Patients Undergoing Structured Treatment Interruptions of Highly Active Antiretroviral Therapy|
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:
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.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Condition ICMJE||HIV Infection|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||February 2002|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
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.
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00001948|
|Other Study ID Numbers ICMJE||000046, 00-CC-0046|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institutes of Health Clinical Center (CC)|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||February 2002|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP