HIV Infection MedDRA version: 9.1 Level: LLT Classification code 10020161 Term: HIV infection
Conditions
Interventions
Trade Name: Isentress 400 mg
Product Code: MK-0518
Pharmaceutical Form: Tablet
INN or Proposed INN: Raltegravir
Current Sponsor code: MK-0518
Concentration unit: mg milligram(s)
Concentration type: e
Sponsors
Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patient is a male or female at least 18 years of age on the day of signing the informed consent. 2) Patient is HIV positive as determined by enzyme-linked immunosorbent assay (ELISA) or HIV PCR. 3) Patient has documented HIV RNA =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Patient is receiving a KALETRA based regimen that includes Stavudine (d4T) as a component of the background antiretroviral therapy. 2) Patient is receiving a KALETRA based regimen that includes a second protease inhibitor in addition to KALETRA. 3) Patient is currently receiving, or has received in the past twelve weeks, agents known to have an effect on lipid levels (for example: fish oils, lipidol, bile-acid sequestrants, HMG-CoA reductase inhibitors [such as simvastatin, atorvastatin, rosuvastatin], ezetimibe, ezetimibe/simvastatin, fibrates, niacin, plant sterols, and/or red yeast). 4) Patient has a medical history which includes diabetes mellitus.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1) To evaluate the change in total cholesterol, triglycerides, non-HDL-C, and LDL-C associated with the use of MK-0518 400 mg b.i.d. compared with KALETRA 400/100 mg b.i.d., each in combination with background antiretroviral therapy, as measured by the mean percent change from baseline in total cholesterol, triglycerides, non-HDL-C, and LDL-C at Week 12. 2) To evaluate the antiretroviral activity of MK-0518 400 mg b.i.d. compared with KALETRA 400/100 mg b.i.d., each in combination with background antiretroviral therapy, as measured by proportion of patients with viral load <50 copies/mL at Week 24. 3) To evaluate the safety and tolerability of MK-0518 400 mg b.i.d. compared with KALETRA 400/100 mg b.i.d., each in combination with background antiretroviral therapy, as assessed by review of the accumulated safety data at Week 24.;Secondary Objective: 1) To evaluate the change in total cholesterol, triglycerides, non-HDL-C, and LDL-C associated with the use of MK-0518 400 mg b.i.d. compared with KALETRA 400/100 mg b.i.d., each in combination with background antiretroviral therapy, as measured by the mean percent change from baseline in total cholesterol, triglycerides, non-HDL-C, and LDL-C at Week 24 and 48. 2) To evaluate the antiretroviral activity of MK-0518 400 mg b.i.d. compared with KALETRA 400/100 mg b.i.d., each in combination with background antiretroviral therapy, as measured by the proportion of patients with viral load <50 copies/mL at Week 48 and the change from baseline in CD4 cell counts at Week 24 and Week 48. 3) To evaluate the safety and tolerability of MK-0518 400 mg b.i.d. compared with KALETRA 400/100 mg b.i.d., each in combination with background antiretroviral therapy, as assessed by review of the accumulated safety data at Week 48. ;Primary end point(s): Efficacy - proportion of patients with plasma HIV RNA < 50 copies/mL at Week 24. Safety - mean percent changes from baseline in total cholesterol, triglycerides, non-HDL-C | — |
Countries
Germany, Italy, Portugal, Spain, United Kingdom
Outcome results
None listed