Human Immunodeficiency Virus
Conditions
Keywords
HIV Infections, Anti-HIV Agents, Anti-Retroviral Agents, Nucleoside Reverse Transcriptase Inhibitors, Non-nucleoside Reverse Transcriptase Inhibitor, Protease inhibitors
Brief summary
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.
Interventions
None listed
Sponsors
Merck Sharp & Dohme LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medical Outcomes Study-HIV (MOS-HIV) Health Survey Scores | 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
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Depression, Anxiety, and Stress Scale (DASS-21) | 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) | 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) | 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. |
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Raltegravir + 2 NRTIs Participants were treated with raltegravir (an integrase inhibitor), and two nucleoside reverse transcriptase inhibitors (NRTIs) | 35 |
| NNRTI + 2 NRTIs Participants were treated with two NRTIs and a non-nucleoside reverse transcriptase inhibitor (NNRTI). | 19 |
| PI + 2 NRTIs Participants were treated with two NRTIs and a protease inhibitor (PI). | 6 |
| Total | 60 |
Baseline characteristics
| Characteristic | Raltegravir + 2 NRTIs | NNRTI + 2 NRTIs | PI + 2 NRTIs | Total |
|---|---|---|---|---|
| Age, Continuous | 46.7 Years STANDARD_DEVIATION 8.9 | 45.2 Years STANDARD_DEVIATION 13.8 | 48.8 Years STANDARD_DEVIATION 4.1 | 46.3 Years STANDARD_DEVIATION 10.3 |
| Sex: Female, Male Female | 14 Participants | 2 Participants | 0 Participants | 16 Participants |
| Sex: Female, Male Male | 21 Participants | 17 Participants | 6 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 36 | 0 / 21 | 0 / 6 |
| serious Total, serious adverse events | 0 / 36 | 0 / 21 | 0 / 6 |
Outcome results
Primary
Medical Outcomes Study-HIV (MOS-HIV) Health Survey Scores
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.
Time frame: Week 4 Follow-up
Population: Analyses were not performed due to too few participants.
Secondary
Change From Baseline in Depression, Anxiety, and Stress Scale (DASS-21)
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.
Time frame: Baseline and Week 4 Follow-up
Population: Analyses were not performed due to too few participants.
Secondary
Change From Baseline in Dermatology Life Quality Index (DLQI)
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.
Time frame: Baseline and Week 4 Follow-up
Population: Analyses were not performed due to too few participants.
Secondary
Change From Baseline in HIV Symptom Index (HIV-SI)
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.
Time frame: Baseline and Week 4 Follow-up
Population: Analyses were not performed due to too few participants.