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)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Raltegravir (MK-0518) (Drug); Nevirapine (Drug); Lamivudine (Drug); Tenofovir (Drug); Emtricitabine (Drug); Lopinavir (Drug); Ritonavir (Drug); Atazanavir (Drug); Darunavir (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Merck Sharp & Dohme Corp. Official(s) and/or principal investigator(s): Medical Director, Study Director, Affiliation: Merck Sharp & Dohme Corp.
Overall contact: Toll Free Number, Phone: 1-888-577-8839
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change from Baseline in estimated Glomerular Filtration Rate (eGFR)
Secondary outcome: Percentage of Participants with Suppressed Viremia (<50 copies/mL HIV-1 Ribonucleic Acid [RNA]) at Week 48Percentage of Participants with Suppressed Viremia (<50 copies/mL HIV-1 RNA) at Week 96 Percentage of Participants with Decline in Renal Function at Week 48
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Toll Free Number, Phone: 1-888-577-8839
MSD Italia S.r.l., Rome, Italy; Recruiting Patrizia Nardini, Phone: 39 06 361911
Additional Information
Starting date: September 2014
Last updated: August 7, 2015
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