Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 39 of 243 for:    "Viral Infectious Disease" | "Lopinavir"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Human Immunodeficiency Virus
Enrollment 63
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.
Pre-assignment Details  
Arm/Group Title Raltegravir + 2 NRTIs NNRTI + 2 NRTIs PI + 2 NRTIs
Hide Arm/Group Description Participants were treated with raltegravir (an integrase inhibitor), and two nucleoside reverse transcriptase inhibitors (NRTIs) Participants were treated with two NRTIs and a non-nucleoside reverse transcriptase inhibitor (NNRTI). Participants were treated with two NRTIs and a protease inhibitor (PI).
Period Title: Overall Study
Started 36 21 6
Completed 36 21 6
Not Completed 0 0 0
Arm/Group Title Raltegravir + 2 NRTIs NNRTI + 2 NRTIs PI + 2 NRTIs Total
Hide Arm/Group Description Participants were treated with raltegravir (an integrase inhibitor), and two nucleoside reverse transcriptase inhibitors (NRTIs) Participants were treated with two NRTIs and a non-nucleoside reverse transcriptase inhibitor (NNRTI). Participants were treated with two NRTIs and a protease inhibitor (PI). Total of all reporting groups
Overall Number of Baseline Participants 35 19 6 60
Hide Baseline Analysis Population Description
Gender and Age data for one participant from the Raltegravir, and two participants from the NNRTI groups were missing, resulting in a n = 60.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 35 participants 19 participants 6 participants 60 participants
46.7  (8.9) 45.2  (13.8) 48.8  (4.1) 46.3  (10.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 19 participants 6 participants 60 participants
Female
14
  40.0%
2
  10.5%
0
   0.0%
16
  26.7%
Male
21
  60.0%
17
  89.5%
6
 100.0%
44
  73.3%
1.Primary Outcome
Title Medical Outcomes Study-HIV (MOS-HIV) Health Survey Scores
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Analyses were not performed due to too few participants.
Arm/Group Title Raltegravir + 2 NRTIs NNRTI + 2 NRTIs PI + 2 NRTIs
Hide Arm/Group Description:
Participants were treated with raltegravir (an integrase inhibitor), and two nucleoside reverse transcriptase inhibitors (NRTIs)
Participants were treated with two NRTIs and a non-nucleoside reverse transcriptase inhibitor (NNRTI).
Participants were treated with two NRTIs and a protease inhibitor (PI).
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Change From Baseline in Depression, Anxiety, and Stress Scale (DASS-21)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Analyses were not performed due to too few participants.
Arm/Group Title Raltegravir + 2 NRTIs NNRTI + 2 NRTIs PI + 2 NRTIs
Hide Arm/Group Description:
Participants were treated with raltegravir (an integrase inhibitor), and two nucleoside reverse transcriptase inhibitors (NRTIs)
Participants were treated with two NRTIs and a non-nucleoside reverse transcriptase inhibitor (NNRTI).
Participants were treated with two NRTIs and a protease inhibitor (PI).
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Change From Baseline in HIV Symptom Index (HIV-SI)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Analyses were not performed due to too few participants.
Arm/Group Title Raltegravir + 2 NRTIs NNRTI + 2 NRTIs PI + 2 NRTIs
Hide Arm/Group Description:
Participants were treated with raltegravir (an integrase inhibitor), and two nucleoside reverse transcriptase inhibitors (NRTIs)
Participants were treated with two NRTIs and a non-nucleoside reverse transcriptase inhibitor (NNRTI).
Participants were treated with two NRTIs and a protease inhibitor (PI).
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Change From Baseline in Dermatology Life Quality Index (DLQI)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Analyses were not performed due to too few participants.
Arm/Group Title Raltegravir + 2 NRTIs NNRTI + 2 NRTIs PI + 2 NRTIs
Hide Arm/Group Description:
Participants were treated with raltegravir (an integrase inhibitor), and two nucleoside reverse transcriptase inhibitors (NRTIs)
Participants were treated with two NRTIs and a non-nucleoside reverse transcriptase inhibitor (NNRTI).
Participants were treated with two NRTIs and a protease inhibitor (PI).
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Up to 14 days following end of the study's observation period
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Raltegravir + 2 NRTIs NNRTI + 2 NRTIs PI + 2 NRTIs
Hide Arm/Group Description Participants were treated with raltegravir (an integrase inhibitor), and two nucleoside reverse transcriptase inhibitors (NRTIs) Participants were treated with two NRTIs and a non-nucleoside reverse transcriptase inhibitor (NNRTI). Participants were treated with two NRTIs and a protease inhibitor (PI).
All-Cause Mortality
Raltegravir + 2 NRTIs NNRTI + 2 NRTIs PI + 2 NRTIs
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Raltegravir + 2 NRTIs NNRTI + 2 NRTIs PI + 2 NRTIs
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/36 (0.00%)   0/21 (0.00%)   0/6 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Raltegravir + 2 NRTIs NNRTI + 2 NRTIs PI + 2 NRTIs
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/36 (0.00%)   0/21 (0.00%)   0/6 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01814722     History of Changes
Other Study ID Numbers: 0518-266
First Submitted: March 18, 2013
First Posted: March 20, 2013
Results First Submitted: October 6, 2014
Results First Posted: October 9, 2014
Last Update Posted: April 21, 2017