A Multicenter, Double-Blind, Randomized, Active-Controlled Study to Evaluate the Safety and Antiretroviral Activity of MK- 0518 Versus Efavirenz in Treatment Naïve HIV-Infected Patients, Each in Combination With TRUVADA™ - MK-0518 safety and efficacy study in treatment naïve patients

• Conditions: HIV Infection; MedDRA version: 8.1Level: LLTClassification code 10020162Term: HIV infection CDC Group I

• Registration Number: EUCTR2006-003109-23-DE
• Lead Sponsor: Merck & Co., Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09-14
• Last Update Posted: 22 October 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 550

Inclusion Criteria

Patient is a male or female at least 18 years of age
Patient is naïve to ART
Patient is HIV positive as determined by a positive result by enzyme-linked immunosorbent assay (ELISA) and has screening plasma HIV RNA (determined by the central laboratory) >5000 copies/mL within 60 days prior to the treatment phase of this study, and is indicated for treatment based on physician assessment. Local treatment guidelines should be considered in the decision to initiate therapy.
Patient has the following laboratory values:
•Serum creatinine =2.0 x upper limit of normal
•Alkaline phosphatase =5.0 x upper limit of normal
•AST (SGOT) and ALT (SGPT) =5.0 x upper limit of normal
Patient has a calculated creatinine clearance at time of screening >30 mL/min, based on the Cockcroft-Gault equation which is as follows (and 0.85X this value for females):
Clcr (mL/min) = (140-age) x weight (in kg)/72 x serum creatinine (mg/dL)
In the opinion of the investigator, the patient should be considered clinically stable with no signs or symptoms of active infection, at the time of entry into the study; i.e., clinical status and all chronic
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patient has been treated for a viral infection other than HIV, such as hepatitis B, with an agent that is active against HIV including but not limited to adefovir, tenofovir, emtricitabine or lamivudine. Note: Patients may be enrolled if treatment occurred prior to the diagnosis of HIV.
Patient has documented resistance to tenofovir, emtricitabine, and/or efavirenz.
Patient has used another experimental HIV-integrase inhibitor
Patient has a current (active) diagnosis of acute hepatitis due to any cause. Patients with chronic hepatitis, including chronic hepatitis B and/or C, may enter the study as long as they have stable liver function tests and meet all inclusion criteria. Patients who, in the opinion of the investigator, have evidence of impairment of hepatic synthetic function, such as hypoalbuminemia or prolonged PT and PTT should be excluded.
Patient has used systemic immunosuppressive therapy within one month prior to treatment in this study. Short courses of corticosteroids (e.g., as for asthma exacerbation) will be allowed.
Patient requires hemodialysis.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified