infección VIH HIV infection MedDRA version: 11 Level: PT Classification code 10020161 Term:
Conditions
Interventions
Trade Name: ISENTRESS
Pharmaceutical Form: Tablet
INN or Proposed INN: RALTEGRAVIR POTASIO
Other descriptive name: RALTEGRAVIR POTASIO
C
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 a positive result by enzyme-linked immunosorbent assay (ELISA) and has screening plasma HIV RNA (determined by the central laboratory) >5000 copies/mL within 45 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. 3. Patient is naïve to antiretroviral therapy (ART), defined as having received 30 mL/min 6. Patient who is of reproductive potential agrees remain abstinent or use (or have their partner use) 2 acceptable methods of birth control throughout the study. 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: 1. Patient has documented resistance to tenofovir, and/or emtricitabine. 2. Patient has used another experimental HIV-integrase inhibitor. 3. 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, no significant impairment of hepatic synthetic function (significant impairment of hepatic synthetic function is defined as a serum albumin 1.7 in the absence of another explanation for the abnormal laboratory value) and meet all other inclusion criteria. 4. Patient is pregnant or breastfeeding, or expecting to conceive (within the duration of the study). Patient is expecting to donate eggs (within the duration of the study). Patient is expecting to donate sperm (within the duration of the study).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Proportion of patients achieving HIV RNA <50 copies/mL at Week 48.; Main Objective: 1) Evaluate the antiretroviral activity of once daily raltegravir, 800 mg q.d.,compared to twice daily raltegravir, 400 mg b.i.d., each in combination therapy with TRUVADA?, as measured by the proportion of patients achieving HIV RNA <50 copies/mL at Week 48. 2) Evaluate the tolerability of once daily raltegravir, 800 mg q.d., compared to twice daily raltegravir, 400 mg b.i.d., each in combination therapy with TRUVADA?, as assessed by review of the accumulated safety data. ; Secondary Objective: 1) Evaluate the antiretroviral activity of once daily raltegravir, 800 mg q.d., compared to twice daily raltegravir, 400 mg b.i.d., each in combination therapy with TRUVADA?, as measured by the following parameters at Week 48: and 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 change in total cholesterol, triglycerides, non-HDL-C, and LDL-C associated with the use of raltegravir 800 mg q.d. compared with raltegravir 400 mg b.i.d., each in combination therapy with TRUVADA?, as measured by the mean change from baseline in total cholesterol, triglycerides, non-HDL-C, and LDL-C at Week 24. | — |
Countries
Denmark, France, Germany, Italy, Netherlands, Portugal, Spain, United Kingdom
Outcome results
None listed