Trial Outcomes & Findings for Quality of Life of HIV-infected Participants Switched to Raltegravir Versus Other Antiretroviral Regimens (MK-0518-266) (NCT NCT01814722)
NCT ID: NCT01814722
Last Updated: 2017-04-21
Results Overview
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.
TERMINATED
63 participants
Week 4 Follow-up
2017-04-21
Participant Flow
Adults with human immunodeficiency virus (HIV) who were switching from first-line antiretroviral regimens to a second-line regimen were recruited at 48 academic and community-based practices in the U.S.A.
Participant milestones
| Measure |
Raltegravir + 2 NRTIs
Participants were treated with raltegravir (an integrase inhibitor), and two nucleoside reverse transcriptase inhibitors (NRTIs)
|
NNRTI + 2 NRTIs
Participants were treated with two NRTIs and a non-nucleoside reverse transcriptase inhibitor (NNRTI).
|
PI + 2 NRTIs
Participants were treated with two NRTIs and a protease inhibitor (PI).
|
|---|---|---|---|
|
Overall Study
STARTED
|
36
|
21
|
6
|
|
Overall Study
COMPLETED
|
36
|
21
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Quality of Life of HIV-infected Participants Switched to Raltegravir Versus Other Antiretroviral Regimens (MK-0518-266)
Baseline characteristics by cohort
| Measure |
Raltegravir + 2 NRTIs
n=35 Participants
Participants were treated with raltegravir (an integrase inhibitor), and two nucleoside reverse transcriptase inhibitors (NRTIs)
|
NNRTI + 2 NRTIs
n=19 Participants
Participants were treated with two NRTIs and a non-nucleoside reverse transcriptase inhibitor (NNRTI).
|
PI + 2 NRTIs
n=6 Participants
Participants were treated with two NRTIs and a protease inhibitor (PI).
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
46.7 Years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
45.2 Years
STANDARD_DEVIATION 13.8 • n=7 Participants
|
48.8 Years
STANDARD_DEVIATION 4.1 • n=5 Participants
|
46.3 Years
STANDARD_DEVIATION 10.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 4 Follow-upPopulation: Analyses were not performed due to too few participants.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 4 Follow-upPopulation: Analyses were not performed due to too few participants.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 4 Follow-upPopulation: Analyses were not performed due to too few participants.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 4 Follow-upPopulation: Analyses were not performed due to too few participants.
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.
Outcome measures
Outcome data not reported
Adverse Events
Raltegravir + 2 NRTIs
NNRTI + 2 NRTIs
PI + 2 NRTIs
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place