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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)

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 48

Percentage 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

Page last updated: August 23, 2015

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