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

Merck Sharp & Dohme (MSD)

Status: Terminated

Conditions: Human Immunodeficiency Virus

Study type: Observational

Funder types: Industry

Identifiers

NCT01814722

0518-266

Details and patient eligibility

About

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.

Enrollment: 63 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

63 participants in 3 patient groups

Raltegravir + 2 NRTIs

Description:

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

NNRTI + 2 NRTIs

Description:

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

PI + 2 NRTIs

Description:

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