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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01814722
First received: March 18, 2013
Last updated: November 19, 2013
Last verified: November 2013

March 18, 2013
November 19, 2013
November 2012
October 2013   (final data collection date for primary outcome measure)
Comparison of Medical Outcomes Study-HIV (MOS-HIV) Health Survey Scores [ Time Frame: Week 4 Follow-up ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01814722 on ClinicalTrials.gov Archive Site
  • Change from Baseline in Depression, Anxiety, and Stress Scale (DASS-21) [ Time Frame: Baseline and Week 4 Follow-up ] [ Designated as safety issue: No ]
  • Change from Baseline in HIV Symptom Index (HIV-SI) [ Time Frame: Baseline and Week 4 Follow-up ] [ Designated as safety issue: No ]
  • Change from Baseline in Dermatology Life Quality Index (DLQI) [ Time Frame: Baseline and Week 4 Follow-up ] [ Designated as safety issue: No ]
Same as current
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Not Provided
 
Quality of Life of HIV-infected Participants Switched to Raltegravir Versus Other Antiretroviral Regimens (MK-0518-266)
Quality of Life of HIV-infected Patients Switched to Raltegravir Versus Other Antiretroviral Regimens

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

HIV patients at academic and community-based practices in the United States

Human Immunodeficiency Virus
Not Provided
  • Raltegravir + 2 NRTIs

    Raltegravir is an integrase inhibitor.

    Nucleoside Reverse Transcriptase Inhibitor (NRTIs)

  • NNRTI + 2 NRTIs
    Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) could include: delavirdine, efavirenz, etravirine, rilpivirine, nevirapine
  • PI + 2 NRTIs
    Protease inhibitors (PI) could include: nelfinavir, lopinavir, saquinavir, tipranavir
  • Other Second Line Therapies
    Other second line therapies could include: enfuvirtide, maraviroc, raltegravir + PI
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
134
October 2013
October 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01814722
0518-266
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP