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)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2014 by Merck Sharp & Dohme Corp.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT02116660
First received: April 15, 2014
Last updated: July 3, 2014
Last verified: July 2014
  Purpose

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 (MK-0518-284)


Condition Intervention 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 Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)(Phase 2b - Protocol No. MK-0518-284-01)

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Change from Baseline in Renal Function [ Time Frame: Baseline and Week 48 ] [ Designated as safety issue: Yes ]
  • Percentage of Participants with Decline in Renal Function at Week 48 [ Time Frame: Week 48 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Percentage of Participants with Suppressed Viremia (<50 copies/mL HIV-1 Ribonucleic Acid [RNA]) at Week 48 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  • Percentage of Participants with Suppressed Viremia (<50 copies/mL HIV-1 RNA) at Week 96 [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
  • Percentage of Participants with Decline in Renal Function at Week 96 [ Time Frame: Week 96 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: July 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Raltegravir plus Nevirapine plus Lamivudine
Raltegravir 400 mg oral twice daily plus 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02116660

Contacts
Contact: Toll Free Number 1-888-577-8839

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02116660     History of Changes
Other Study ID Numbers: 0518-284, 2013-001637-40
Study First Received: April 15, 2014
Last Updated: July 3, 2014
Health Authority: Italy: The Italian Medicines Agency

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Renal Insufficiency
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Kidney Diseases
Urologic Diseases
Protease Inhibitors
Ritonavir
Lopinavir
Atazanavir
Darunavir
HIV Protease Inhibitors
Nevirapine
Lamivudine
Tenofovir
Tenofovir disoproxil
Emtricitabine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents

ClinicalTrials.gov processed this record on July 22, 2014