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

NCT01814722 | Terminated Results

• 1 other identifier: 0518-266
• Study Type: observational
• Target: 63
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Human Immunodeficiency Virus

Keywords

HIV Infections; Anti-HIV Agents; Anti-Retroviral Agents; Nucleoside Reverse Transcriptase Inhibitors; Non-nucleoside Reverse Transcriptase Inhibitor; Protease inhibitors

Outcome Measures

Primary Outcomes (1)

• Medical Outcomes Study-HIV (MOS-HIV) Health Survey Scores

  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.

  Week 4 Follow-up

Secondary Outcomes (3)

• Change From Baseline in Depression, Anxiety, and Stress Scale (DASS-21)

  Baseline and Week 4 Follow-up

• Change From Baseline in HIV Symptom Index (HIV-SI)

  Baseline and Week 4 Follow-up

• Change From Baseline in Dermatology Life Quality Index (DLQI)

  Baseline and Week 4 Follow-up

Study Arms (3)

Raltegravir + 2 NRTIs

Raltegravir is an integrase inhibitor. Two Nucleoside Reverse Transcriptase Inhibitor (NRTIs)

NNRTI + 2 NRTIs

Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) could include: delavirdine, efavirenz, etravirine, rilpivirine, nevirapine; and two NRTIs.

PI + 2 NRTIs

Protease inhibitors (PI) could include: nelfinavir, lopinavir, saquinavir, tipranavir, atazanavir and darunavir; and two NRTIs.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Clinical diagnosis of HIV
• Switching antiretroviral regimen(s) for the first time at the start of the study

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2013
• First Posted: March 20, 2013
• Study Start: November 9, 2012
• Primary Completion: October 31, 2013
• Study Completion: October 31, 2013
• Last Updated: April 21, 2017
• Results First Posted: October 9, 2014

Record last verified: 2017-03