MedTrace Logo

Evaluation of Renal Function, Efficacy, and Safety When Switching From Tenofovir/Emtricitabine Plus a Protease Inhibitor/Ritonavir, to a Combination of Raltegravir (MK-0518) Plus Nevirapine Plus Lamivudine in HIV-1 Participants With Suppressed Viremia and Impaired Renal Function (MK-0518-284)

NCT02116660 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2019-04-08

Study results available
· View outcomes & findings →

Summary

To evaluate changes in renal function, efficacy, and safety when switching from a combination of tenofovir/emtricitabine (TDF/FTC) plus a protease inhibitor/ritonavir (PI/r) to a combination of raltegravir (MK-0518) plus nevirapine plus lamivudine in human immunodeficiency virus (HIV)-1 infected participants with suppressed viremia and impaired renal function.

Conditions

  • HIV Infections

Interventions

DRUG

Raltegravir (MK-0518)

Raltegravir (MK-0518) 400 mg tablets

DRUG

Nevirapine

Nevirapine (NVP) 200 mg tablets

DRUG

Lamivudine

Lamivudine (3TC) 150 mg tablets

DRUG

Tenofovir

Tenofovir disoproxil fumarate (TDF) 300 mg tablets

DRUG

Emtricitabine

Emtricitabine (FTC) 200 mg tablets

DRUG

Lopinavir

Lopinavir (LPV) 200 mg tablets

DRUG

Ritonavir

Ritonavir (r) 100 mg tablets

DRUG

Atazanavir

Atazanavir (ATV) 300 mg tablets

DRUG

Darunavir

Darunavir (DAR) 400 mg tablets

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-03
Primary Completion
2017-07-10
Completion
2017-07-10

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02116660 on ClinicalTrials.gov