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TERMINATEDPHASE2

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)

Switching From Regimens Consisting of a RTV-Boosted Protease Inhibitor Plus TDF/FTC to a Combination of Raltegravir Plus Nevirapine and Lamivudine in HIV Patients With Suppressed Viremia and Impaired Renal Function (RANIA Study) (Pilot Study) Protocol MK-0518-284-03

NCT02116660•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male, or non-pregnant, non-breastfeeding female
•No previous history of virological failure
•No previous exposure to non-nucleoside reverse transcriptase inhibitors or integrase inhibitors
•No previous history of intolerance to lamivudine
•At least 2 documented plasma HIV-1 RNA \<50 copies/mL and no HIV-1 \>50 copies/mL in the 12 months before screening
•Receiving the same protease inhibitor/ritonavir plus tenofovir/emtricitabine combination for at least the 6 months before screening
•Has no major International Antiviral Society (IAS)-USA mutations on genotype testing performed before starting antiretroviral treatment
•Sexually-active participants and their partners of child-bearing potential agree to use a medically acceptable method of contraception from 2 weeks before Day 1 and for at least 6 months after the last dose of study drug (postmenopausal women are not required to use contraception; sexually-active male participants with a female partner of child-bearing potential must provide written informed consent to information regarding any pregnancy)

Exclusion Criteria

•Positive for hepatitis B surface antigen (HBsAg+) or anticipated need for hepatitis C virus treatment
•Liver cirrhosis
•Has a history of diabetes mellitus, defined as initiation of antidiabetic treatment or verification of diabetes in a case report form
•Has any cancer, excluding stable Kaposi Sarcoma
•Allergy or sensitivity to the investigational product or excipients
•Female participant who is nursing
•Female participant who is pregnant or intends to become pregnant
•Has an active Acquired Immunodeficiency Syndrome (AIDS)-defining event except stable Kaposi Sarcoma or HIV Wasting Syndrome
•Received any investigational drug within 30 days before screening
•Participated in any other clinical trial within 30 days before signing informed consent for the current trial

Key Dates

Start Date

September 3, 2014

Primary Completion Date

July 10, 2017

Completion Date

July 10, 2017

Last Updated

April 8, 2019

Enrollment

ACTUAL participants

Conditions

HIV Infections

Interventions

Raltegravir (MK-0518)

DRUG

Nevirapine

DRUG

Lamivudine

DRUG

Tenofovir

DRUG

Emtricitabine

DRUG

Lopinavir

DRUG

Ritonavir

DRUG

Atazanavir

DRUG

Darunavir

DRUG

Skeletal Muscle Energetics and Fatiguability in Older Individuals

NCT04142047

HIVHIV Infections

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RECRUITINGPHASE3

A Study to Evaluate the Effectiveness of Long-acting (LA) Cabotegravir (CAB) + Rilpivirine (RPV) LA When Given to Participants With Detectable HIV-1

NCT06694805

HIV Infections

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 8, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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)

Inclusion Criteria

Exclusion Criteria

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A Study to Evaluate the Effectiveness of Long-acting (LA) Cabotegravir (CAB) + Rilpivirine (RPV) LA When Given to Participants With Detectable HIV-1

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