A Study to Evaluate the Safety and Antiretroviral Activity of MK-0518 Versus Efavirenz in Treatment Naive HIV-Infected Patients, Each in Combination With TRUVADA (0518-021 EXT)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: HIV Infections

Treatments: Drug: Comparator: Placebo to efavirenz; Drug: Comparator: efavirenz; Drug: Comparator: Truvada; Drug: MK-0518; Drug: Comparator: Placebo to MK-0518

Study type: Interventional

Funder types: Industry

Identifiers

NCT00369941

MK-0518-021 (Other Identifier)

0518-021

2006_519 (Other Identifier)

Details and patient eligibility

About

This study will investigate the safety and efficacy of MK-0518 versus efavirenz, in combination with TRUVADA, as a therapy for Human Immunodeficiency Virus (HIV)-infected patients not previously treated.

Enrollment: 566 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participant is a male or female at least 18 years of age
• Participant is HIV positive
• Participant is naïve to antiretroviral therapy (ART) and has not received any ART

Exclusion criteria

• Participant has received approved or experimental antiretroviral agents in the past
• Participant has been treated for a viral infection other than HIV such as hepatitis B virus infection with an agent that is active against HIV including but not limited to adefovir or lamivudine (= 7 days total)
• Participant has documented resistance to tenofovir, emtricitabine, and/or efavirenz
• Participant has used another experimental HIV-integrase inhibitor
• Participant has a current (active) diagnosis of acute hepatitis due to any cause
• Participants with chronic hepatitis including chronic hepatitis B and/or C may enter the study as long as they have stable liver function tests

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

566 participants in 2 patient groups

MK-0518 400 mg b.i.d.

Experimental group

Description:

MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.

Treatment:

Drug: MK-0518

Drug: Comparator: Truvada

Drug: Comparator: Placebo to efavirenz

Efavirenz 600 mg q.h.s.

Active Comparator group

Description:

Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.

Treatment:

Drug: Comparator: Truvada

Drug: Comparator: efavirenz

Drug: Comparator: Placebo to MK-0518