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)
This trial is active, not recruiting.
|Treatments||raltegravir (mk-0518), nevirapine, lamivudine, tenofovir, emtricitabine, lopinavir, ritonavir, atazanavir, darunavir|
|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.
|Endpoint classification||safety study|
|Intervention model||parallel assignment|
Change from Baseline in estimated Glomerular Filtration Rate (eGFR)
time frame: Baseline and Week 48
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
Male or female 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
|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|
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