HIV Infection MedDRA version: 8.1 Level: LLT Classification code 10020162 Term: HIV infection CDC Group I
Conditions
Interventions
Product Name: MK-0518
Product Code: MK-0518
Pharmaceutical Form: Tablet
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 400-
Pharmaceutical form of the placebo: Tab
Sponsors
Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1.To evaluate the antiretroviral activity of MK-0518 400 mg b.i.d. compared with efavirenz 600 mg q.h.s., each in combination therapy with TRUVADA™, as measured by proportion of patients achieving HIV RNA <50 copies/mL at Week 48. 2.To evaluate the safety and tolerability of MK-0518 400 mg b.i.d. compared with efavirenz 600 mg q.h.s., each in combination therapy with TRUVADA™, as assessed by review of the accumulated safety data at Week 48. ;Secondary Objective: 1.Evaluate the antiretroviral activity of MK-0518 400 mg b.i.d. compared with efavirenz 600 mg q.h.s., each in combination therapy with TRUVADA™, as measured by the following parameters at Week 48: proportion of patients achieving HIV RNA <400 copies/mL, change from baseline in CD4 cell counts and at Week 96: proportion of patients achieving HIV RNA <50 copies/mL, proportion of patients achieving HIV RNA <400 copies/mL, change from baseline in CD4 cell counts. 2.To evaluate the safety and tolerability of MK-0518 400 mg b.i.d. compared with efavirenz 600 mg q.h.s., each in combination therapy with TRUVADA™, as assessed by review of the accumulated safety data up to Week 96. 3.To evaluate the nervous system symptoms associated with the use of MK-0518 400 mg b.i.d. compared with efavirenz 600 mg q.h.s., each in combination therapy with TRUVADA™, as measured by proportion of patients with nervous system symptoms assessed by review of accumulated safety data up to Week 8. ;Primary end point(s): Efficacy: Proportion of patients achieving HIV RNA <50 copies/mL at Wk 48 Safety:Proportion of patients with adverse experiences for the following clinical adverse experiences: 1) at least one; 2)drug related; 3) serious; 4) serious and drug related; 5) discontinued study therapy due to an adverse experience. Proportion of patients with any specified nervous system adverse experience. | — |
Countries
France, Germany, Italy, Spain
Outcome results
None listed