HIV MedDRA version: 14.1 Level: LLT Classification code 10068341 Term: HIV-1 infection System Organ Class: 100000004862
Conditions
Interventions
Trade Name: ISENTRESS
Product Name: Isentress
Pharmaceutical Form: Tablet
INN or Proposed INN: RALTEGRAVIR
CAS Number: 518048-05-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concent
Sponsors
Arbeitsgemeinschaft medikamentöse Tumortherapie gemeinnützige GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Signed informed consent • Documented HIV-1 infection in female patients, age =18 years • Patients receiving antiretroviral therapy consisting of at least 2 antiretroviral agents other than protease inhibitor plus a ritonavir-boosted protease inhibitor (PI) including indinavir, fosamprenavir, saquinavir, lopinavir, atazanavir, tipranavir, or darunavir for at least the previous 6 months • Plasma HIV viral load 8.0g/dl o neutrophil count > 750/µl o platelet count > 50000/µl o creatinine 130 mg/dl Fasting triglycerides =65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: • Breast feeding or pregnancy or wish to become pregnant during the study period. • Lack of expectation to maintain assigned medication during study period • NRTI mutations • Prior treatment with raltegravir • Prior treatment with investigational drugs in the previous 3 months • Need for medication with known interactions with raltegravir (rifampin for example) • Active drug or alcohol abuse • Unstable clinical condition • Visceral Kaposi sarcoma • Acute hepatitis in the previous 6 months • Any condition or history or any illness which, in the opinion of the investigator, might confound the results of the study or pose additional risk when switching the therapy of the patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Objective: A reduction of > 5% in the plasma concentration of direct LDL cholesterol from baseline to week 12 or > 10% reduction of total cholesterol or reduction of lipid lowering agents is expected. Reduction of lipid lowering agents is defined as reduction due to amelioration of lipid profiles and does not include reduction due to side effects or other toxicity issues. ;Secondary Objective: • To assess changes and percent changes from baseline in total cholesterol, triglycerides and HDL cholesterol over time and at endpoint • To evaluate risk reduction of cardiovascular risk during the treatment period according to Framingham risk score calculation • To evaluate percent changes from baseline to endpoint in triglycerides and an advanced lipoprotein analysis as well as determination of insulin (HOMA- IR index) • Optional: To evaluate and compare endothelial function as determined with flow mediated dilatation ;Primary end point(s): A reduction of > 5% in the plasma concentration of direct LDL cholesterol from baseline to week 12 or > 10% reduction of total cholesterol or reduction of lipid lowering agents is expected. Reduction of lipid lowering agents is defined as reduction due to amelioration of lipid profiles and does not include reduction due to side effects or other toxicity issues. ;Timepoint(s) of evaluation of this end point: 4 +12 + 24 after treatment start | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • To assess changes and percent changes from baseline in total cholesterol, triglycerides and HDL cholesterol over time and at endpoint • To evaluate risk reduction of cardiovascular risk during the treatment period according to Framingham risk score calculation • To evaluate percent changes from baseline to endpoint in triglycerides and an advanced lipoprotein analysis as well as determination of insulin (HOMA- IR index) • Optional: To evaluate and compare endothelial function as determined with flow mediated dilatation ;Timepoint(s) of evaluation of this end point: 4 +12 + 24 after treatment start | — |
Countries
Austria
Contacts
Public ContactDaniela Wolkersdorfer
AGMT
Outcome results
None listed