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

NCT ID: NCT01814722

Last Updated: 2017-04-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

63 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-11-09

Study Completion Date

2013-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Human Immunodeficiency Virus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Raltegravir + 2 NRTIs

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

No interventions assigned to this group

NNRTI + 2 NRTIs

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

No interventions assigned to this group

PI + 2 NRTIs

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Study Documents

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Document Type: CSR Synopsis

View Document

Other Identifiers

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0518-266

Identifier Type: -

Identifier Source: org_study_id

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