Quality of Life of HIV-infected Participants Switched to Raltegravir Versus Other Antiretroviral Regimens (MK-0518-266)
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|ClinicalTrials.gov Identifier: NCT01814722|
Recruitment Status : Terminated (The trial was terminated early due to slow recruitment.)
First Posted : March 20, 2013
Results First Posted : October 9, 2014
Last Update Posted : April 21, 2017
|Condition or disease|
|Human Immunodeficiency Virus|
|Study Type :||Observational|
|Actual Enrollment :||63 participants|
|Official Title:||Quality of Life of HIV-infected Patients Switched to Raltegravir Versus Other Antiretroviral Regimens|
|Actual Study Start Date :||November 9, 2012|
|Actual Primary Completion Date :||October 31, 2013|
|Actual Study Completion Date :||October 31, 2013|
Raltegravir + 2 NRTIs
Raltegravir is an integrase inhibitor. Two Nucleoside Reverse Transcriptase Inhibitor (NRTIs)
NNRTI + 2 NRTIs
Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) could include: delavirdine, efavirenz, etravirine, rilpivirine, nevirapine; and two NRTIs.
PI + 2 NRTIs
Protease inhibitors (PI) could include: nelfinavir, lopinavir, saquinavir, tipranavir, atazanavir and darunavir; and two NRTIs.
- Medical Outcomes Study-HIV (MOS-HIV) Health Survey Scores [ Time Frame: Week 4 Follow-up ]The MOS-HIV scale is a 35-item measure of health related quality of life (QOL) questionnaire which assesses 10 dimensions of health (general health perceptions, pain, physical functioning, role functioning, social functioning, mental health, energy/fatifue, cognitive function, health distress and QOL), as well as a single item to assess health transition. In addition to these subscales, a Physical Health Summary score (PHS) and a Mental Health Summary score (MHS) is calculated using a method where the summary scores are transformed to a standardized scale with a norm of 50 and a standard deviation of 10 in the sample in which the summary scores were developed. The subscales of the MOS-HIV are scored as summed rating scales ranging from a minimum of 0, to a maximum of 100, where higher scores indicate better health.
- Change From Baseline in Depression, Anxiety, and Stress Scale (DASS-21) [ Time Frame: Baseline and Week 4 Follow-up ]DASS-21 is comprised of questionnaires for three separate scales measuring Depression, Anxiety and Stress. The depression scale is scored by summing the responses of each question, multiplying by 2 and then scoring on a scale ranging from a minimum of 0 to a maximum of 28+, with higher scores indicating greater severity. The anxiety scale is scored by summing the responses of each question, multiplying by 2 and then scoring on a scale ranging from a minimum of 0 to a maximum of 20+, with higher scores indicating greater severity. The stress scale is scored by summing the responses of each question, multiplying by 2 and then scoring on a scale ranging from a minimum of 0 to a maximum of 37+, with higher scores indicating greater severity.
- Change From Baseline in HIV Symptom Index (HIV-SI) [ Time Frame: Baseline and Week 4 Follow-up ]HIV-SI measures the frequency and level of bothersome HIV and HIV treatment-related symptoms, including nervous symptoms (dizziness, somnolence, trouble remembering), gastrointestinal symptoms (nausea, gas/bloating, diarrhea) and pain (hand/foot, muscle/joint). The 20-item questionnaire asks whether respondents experienced any one of these symptoms within the past 4 weeks, and if they did, what the relative level of bother for each symptom was, based on a 5-point Likert scale. The maximum sum of scores is 80; the minimum is 0; with a higher score indicating greater symptom distress.
- Change From Baseline in Dermatology Life Quality Index (DLQI) [ Time Frame: Baseline and Week 4 Follow-up ]DLQI is a 10-question dermatology-specific QOL questionnaire, which is calculated by summing the score of each question, resulting in a maximum of 30, and a minimum of 0. Higher scores mean the QOL is more impaired.
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): NCT01814722
|Study Director:||Medical Director||Merck Sharp & Dohme Corp.|