Quality of Life of HIV-infected Participants Switched to Raltegravir Versus Other Antiretroviral Regimens (MK-0518-266) - Full Text View

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:

MedlinePlus related topics: Anxiety HIV/AIDS

Drug Information available for: Raltegravir Raltegravir potassium

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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
Study Start Date:	November 2012
Study Completion Date:	October 2013
Primary Completion Date:	October 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
Genders Eligible for Study:	Both
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

Sponsors and Collaborators

Merck Sharp & Dohme Corp.

Investigators


Study Director:	Medical Director	Merck Sharp & Dohme Corp.

More Information

No publications provided


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:	October 6, 2014
Health Authority:	United States: Food and Drug Administration

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:


Acquired Immunodeficiency Syndrome HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases	Virus Diseases Reverse Transcriptase Inhibitors Anti-Infective Agents Anti-Retroviral Agents Antiviral Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Nucleic Acid Synthesis Inhibitors Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015