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Quality of Life of HIV-infected Participants Switched to Raltegravir Versus Other Antiretroviral Regimens (MK-0518-266)
This study has been terminated.
(The trial was terminated early due to slow recruitment.)
Sponsor:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01814722
First received: March 18, 2013
Last updated: March 23, 2017
Last verified: March 2017
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Purpose
This is a multi-center, longitudinal observational study of adult human immunodeficiency virus (HIV) participants at academic and community-based practices in the United States who are switching from first-line to second-line therapy. The study's primary hypothesis is that HIV participants switching to raltegravir-based regimens will have better Medical Outcomes Study-HIV (MOS-HIV) Health Survey scores than participants switched to non-nucleoside reverse transcriptase inhibitor (NNRTI)-based or protease inhibitor (PI)-based regimens.
| Condition |
|---|
| Human Immunodeficiency Virus |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Quality of Life of HIV-infected Patients Switched to Raltegravir Versus Other Antiretroviral Regimens |
Resource links provided by NLM:
Further study details as provided by Merck Sharp & Dohme Corp.:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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.
| Enrollment: | 63 |
| Actual Study Start Date: | November 9, 2012 |
| Study Completion Date: | October 31, 2013 |
| Primary Completion Date: | October 31, 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
HIV patients at academic and community-based practices in the United States
Criteria
Inclusion Criteria:
- Clinical diagnosis of HIV
- Switching antiretroviral regimen(s) for the first time at the start of the study
Exclusion Criteria:
- Currently pregnant
- Presence of active tuberculosis, Hepatitis B, and/or Hepatitis C and receiving treatment for the condition(s) during the study period
- Presence of active pneumonia or other signs of opportunistic infections at the start of the study
- Currently participating in a clinical trial
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01814722
Please refer to this study by its ClinicalTrials.gov identifier: NCT01814722
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
| Study Director: | Medical Director | Merck Sharp & Dohme Corp. |
More Information
Study Data/Documents: CSR Synopsis
| Responsible Party: | Merck Sharp & Dohme Corp. |
| ClinicalTrials.gov Identifier: | NCT01814722 History of Changes |
| Other Study ID Numbers: |
0518-266 |
| Study First Received: | March 18, 2013 |
| Results First Received: | October 6, 2014 |
| Last Updated: | March 23, 2017 |
Keywords provided by Merck Sharp & Dohme Corp.:
|
HIV Infections Anti-HIV Agents Anti-Retroviral Agents |
Nucleoside Reverse Transcriptase Inhibitors Non-nucleoside Reverse Transcriptase Inhibitor Protease inhibitors |
Additional relevant MeSH terms:
|
Immunologic Deficiency Syndromes Acquired Immunodeficiency Syndrome HIV Infections Immune System Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Reverse Transcriptase Inhibitors |
Raltegravir Potassium Protease Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Anti-HIV Agents HIV Integrase Inhibitors Integrase Inhibitors |
ClinicalTrials.gov processed this record on June 22, 2017