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)
Condition: HIV Infections
MeSH terms: Viremia; Renal Insufficiency
Intervention: Raltegravir (MK-0518); Nevirapine; Lamivudine; Tenofovir; Emtricitabine; Lopinavir; Ritonavir; Atazanavir; Darunavir
Intervention description: Raltegravir (MK-0518) 400 mg tablets; Nevirapine (NVP) 200 mg tablets; Lamivudine (3TC) 150 mg tablets; 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
Intervention MeSH terms: Ritonavir; Lopinavir; Atazanavir Sulfate; Darunavir; Tenofovir; Lamivudine; Emtricitabine; Raltegravir Potassium; Nevirapine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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 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