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
  Purpose

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.


Condition
Human Immunodeficiency Virus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quality of Life of HIV-infected Patients Switched to Raltegravir Versus Other Antiretroviral Regimens

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Comparison of Medical Outcomes Study-HIV (MOS-HIV) Health Survey Scores [ Time Frame: Week 4 Follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 134
Study Start Date: November 2012
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01814722     History of Changes
Other Study ID Numbers: 0518-266
Study First Received: March 18, 2013
Last Updated: November 19, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
HIV Infections
Anti-HIV Agents
Anti-Retroviral Agents
Nucleoside Reverse Transcriptase Inhibitors
Non-nucleoside Reverse Transcriptase Inhibitor
Protease inhibitors

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases
Protease Inhibitors
HIV Protease Inhibitors
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on August 19, 2014