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 Virem

• Status: Terminated
• Trial end date: 2017-07-10
• Target enrollment: 0
• Participant gender: All

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 infected participants with suppressed viremia and impaired renal function.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Atazanavir Sulfate; Darunavir; Emtricitabine; HIV Protease Inhibitors; Lamivudine; Lopinavir; Nevirapine; Protease Inhibitors; Raltegravir Potassium; Ritonavir; Tenofovir

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