This trial is active, not recruiting.

Condition hiv infections
Treatments raltegravir (mk-0518), nevirapine, lamivudine, tenofovir, emtricitabine, lopinavir, ritonavir, atazanavir, darunavir
Phase phase 2
Sponsor Merck Sharp & Dohme Corp.
Start date September 2014
End date August 2017
Trial size 100 participants
Trial identifier NCT02116660, 0518-284, 2013-001637-40


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 participants with suppressed viremia and impaired renal function.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Primary purpose treatment
Masking no masking
Raltegravir 400 mg oral twice daily, 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
raltegravir (mk-0518)
Raltegravir (MK-0518) 400 mg tablets
Nevirapine (NVP) 200 mg tablets
Lamivudine (3TC) 150 mg tablets
(Active Comparator)
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
Tenofovir disoproxil fumarate (TDF) 300 mg tablets
Emtricitabine (FTC) 200 mg tablets
Lopinavir (LPV) 200 mg tablets
Ritonavir (r) 100 mg tablets
Atazanavir (ATV) 300 mg tablets
Darunavir (DAR) 400 mg tablets

Primary Outcomes

Change from Baseline in estimated Glomerular Filtration Rate (eGFR)
time frame: Baseline and Week 48

Secondary Outcomes

Percentage of Participants with Suppressed Viremia (<50 copies/mL HIV-1 Ribonucleic Acid [RNA]) at Week 48
time frame: Week 48
Percentage of Participants with Suppressed Viremia (<50 copies/mL HIV-1 RNA) at Week 96
time frame: Week 96
Percentage of Participants with Decline in Renal Function at Week 48
time frame: Week 48

Eligibility Criteria

All participants at least 18 years old.

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

Additional Information

Official title 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-0518-284-02
Trial information was received from ClinicalTrials.gov and was last updated in March 2017.
Information provided to ClinicalTrials.gov by Merck Sharp & Dohme Corp..