A Multicenter, Double-Blind, Randomized, Active-Controlled Study to Evaluate the Safety and Antiretroviral Activity of MK- 0518 Versus Efavirenz in Treatment Na ve HIV-Infected Patients, Each in Combination With TRUVADA - ND

• Conditions: aive pts with HIV infection RNA 5000 copies/mL; MedDRA version: 9.1Level: LLTClassification code 10048440Term: HIV infection CDC category A1

• Registration Number: EUCTR2006-003109-23-IT
• Lead Sponsor: MERCK SHARP DOHME

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04-03
• Last Update Posted: 2 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 na ve 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 8804;2.0 x upper limit of normal Alkaline phosphatase 8804;5.0 x upper limit of normal AST SGOT and ALT SGPT 8804;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) no
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