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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) (RANIA)

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ClinicalTrials.gov Identifier: NCT02116660
Recruitment Status : Completed
First Posted : April 17, 2014
Last Update Posted : August 7, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Description
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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 participants with suppressed viremia and impaired renal function.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Raltegravir (MK-0518) Drug: Nevirapine Drug: Lamivudine Drug: Tenofovir Drug: Emtricitabine Drug: Lopinavir Drug: Ritonavir Drug: Atazanavir Drug: Darunavir Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 3, 2014
Actual Primary Completion Date : July 10, 2017
Actual Study Completion Date : July 10, 2017

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: Raltegravir plus Nevirapine plus Lamivudine
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
 Drug: Raltegravir (MK-0518)
Raltegravir (MK-0518) 400 mg tablets
Drug: Nevirapine
Nevirapine (NVP) 200 mg tablets
Drug: Lamivudine
Lamivudine (3TC) 150 mg tablets
Active Comparator: 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
 Drug: Tenofovir
Tenofovir disoproxil fumarate (TDF) 300 mg tablets
Drug: Emtricitabine
Emtricitabine (FTC) 200 mg tablets
Drug: Lopinavir
Lopinavir (LPV) 200 mg tablets
Drug: Ritonavir
Ritonavir (r) 100 mg tablets
Drug: Atazanavir
Atazanavir (ATV) 300 mg tablets
Drug: Darunavir
Darunavir (DAR) 400 mg tablets


Outcome Measures
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Primary Outcome Measures :
  1. Change from Baseline in estimated Glomerular Filtration Rate (eGFR) [ Time Frame: Baseline and Week 48 ]

Secondary Outcome Measures :
  1. Percentage of Participants with Suppressed Viremia (<50 copies/mL HIV-1 Ribonucleic Acid [RNA]) at Week 48 [ Time Frame: Week 48 ]
  2. Percentage of Participants with Suppressed Viremia (<50 copies/mL HIV-1 RNA) at Week 96 [ Time Frame: Week 96 ]
  3. Percentage of Participants with Decline in Renal Function at Week 48 [ Time Frame: Week 48 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02116660


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02116660     History of Changes
Other Study ID Numbers: 0518-284
2013-001637-40 ( EudraCT Number )
First Posted: April 17, 2014    Key Record Dates
Last Update Posted: August 7, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
HIV Infections
Renal Insufficiency
Viremia
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Kidney Diseases
Urologic Diseases
Sepsis
Systemic Inflammatory Response Syndrome
 Inflammation
Pathologic Processes
Ritonavir
Lopinavir
Darunavir
Atazanavir Sulfate
HIV Protease Inhibitors
Tenofovir
Lamivudine
Raltegravir Potassium
Emtricitabine
Nevirapine
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action