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 currently recruiting participants. (see Contacts and Locations)
Verified October 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: October 1, 2014
Last verified: October 2014

April 15, 2014
October 1, 2014
September 2014
October 2015   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT02116660 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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)
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)

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)

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: Raltegravir (MK-0518)
    Raltegravir (MK-0518) 400 mg tablets
  • Drug: Nevirapine
    Nevirapine (NVP) 200 mg tablets
  • Drug: Lamivudine
    Lamivudine (3TC) 150 mg tablets
  • 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
  • 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
    Interventions:
    • Drug: Raltegravir (MK-0518)
    • Drug: Nevirapine
    • Drug: Lamivudine
  • 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
    Interventions:
    • Drug: Tenofovir
    • Drug: Emtricitabine
    • Drug: Lopinavir
    • Drug: Ritonavir
    • Drug: Atazanavir
    • Drug: Darunavir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
December 2016
October 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Toll Free Number 1-888-577-8839
Italy
 
NCT02116660
0518-284, 2013-001637-40
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP