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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

Page last updated: August 23, 2015

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