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)

NCT ID: NCT02116660

Last Updated: 2019-04-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-03
• Study Completion Date: 2017-07-10

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Raltegravir plus Nevirapine plus Lamivudine

Raltegravir 400 mg oral twice daily for 96 weeks; plus nevirapine 200 mg oral once daily for 14 days followed by nevirapine 200 mg oral twice daily, plus lamivudine 150 mg oral twice daily for 96 weeks

Group Type: EXPERIMENTAL

Raltegravir (MK-0518)

Intervention Type: DRUG

Raltegravir (MK-0518) 400 mg tablets

Nevirapine

Intervention Type: DRUG

Nevirapine (NVP) 200 mg tablets

Lamivudine

Intervention Type: DRUG

Lamivudine (3TC) 150 mg tablets

Protease Inhibitor/Ritonavir plus tenofovir/emtricitabine

Tenofovir/emtricitabine 300/200 mg oral once daily plus 1) lopinavir/ritonavir 400/100 mg oral twice daily or 800/200 mg oral once daily, or 2) atazanavir/ritonavir 300/100 mg oral once daily, or 3) darunavir/ritonavir 800/100 mg oral once daily or 600/100 mg oral twice daily

Group Type: ACTIVE_COMPARATOR

Tenofovir

Intervention Type: DRUG

Tenofovir disoproxil fumarate (TDF) 300 mg tablets

Emtricitabine

Intervention Type: DRUG

Emtricitabine (FTC) 200 mg tablets

Lopinavir

Intervention Type: DRUG

Lopinavir (LPV) 200 mg tablets

Ritonavir

Intervention Type: DRUG

Ritonavir (r) 100 mg tablets

Atazanavir

Intervention Type: DRUG

Atazanavir (ATV) 300 mg tablets

Darunavir

Intervention Type: DRUG

Darunavir (DAR) 400 mg tablets

Interventions

Raltegravir (MK-0518)

Raltegravir (MK-0518) 400 mg tablets

Intervention Type: DRUG

Nevirapine

Nevirapine (NVP) 200 mg tablets

Intervention Type: DRUG

Lamivudine

Lamivudine (3TC) 150 mg tablets

Intervention Type: DRUG

Tenofovir

Tenofovir disoproxil fumarate (TDF) 300 mg tablets

Intervention Type: DRUG

Emtricitabine

Emtricitabine (FTC) 200 mg tablets

Intervention Type: DRUG

Lopinavir

Lopinavir (LPV) 200 mg tablets

Intervention Type: DRUG

Ritonavir

Ritonavir (r) 100 mg tablets

Intervention Type: DRUG

Atazanavir

Atazanavir (ATV) 300 mg tablets

Intervention Type: DRUG

Darunavir

Darunavir (DAR) 400 mg tablets

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2013-001637-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MK-0518-284

Identifier Type: OTHER

Identifier Source: secondary_id

0518-284

Identifier Type: -

Identifier Source: org_study_id