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)

Merck Sharp & Dohme (MSD)

Status and phase

Terminated

Phase 2

Conditions

HIV Infections

Treatments

Drug: Atazanavir

Drug: Nevirapine

Drug: Lamivudine

Drug: Tenofovir

Drug: Lopinavir

Drug: Ritonavir

Drug: Raltegravir (MK-0518)

Drug: Emtricitabine

Drug: Darunavir

Study type

Interventional

Funder types

Industry

Identifiers

NCT02116660

0518-284

2013-001637-40 (EudraCT Number)

MK-0518-284 (Other Identifier)

Details and patient eligibility

About

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 infected participants with suppressed viremia and impaired renal function.

Enrollment

11 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

11 participants in 2 patient groups

Raltegravir plus Nevirapine plus Lamivudine

Experimental group

Description:

Raltegravir 400 mg oral twice daily for 96 weeks; 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

Treatment: