Quality of Life of HIV-infected Participants Switched to Raltegravir Versus Other Antiretroviral Regimens (MK-0518-266)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Human Immunodeficiency Virus
Phase: N/A
Status: Terminated
Sponsored by: Merck Sharp & Dohme Corp. Official(s) and/or principal investigator(s): Medical Director, Study Director, Affiliation: Merck Sharp & Dohme Corp.
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.
Clinical Details
Official title: Quality of Life of HIV-infected Patients Switched to Raltegravir Versus Other Antiretroviral Regimens
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Medical Outcomes Study-HIV (MOS-HIV) Health Survey Scores
Secondary outcome: Change From Baseline in Depression, Anxiety, and Stress Scale (DASS-21)Change From Baseline in HIV Symptom Index (HIV-SI) Change From Baseline in Dermatology Life Quality Index (DLQI)
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: November 2012
Last updated: October 6, 2014
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