HIV-1 Infection MedDRA version: 9.1 Level: LLT Classification code 10020161 Term: HIV infection
Conditions
Interventions
Product Name: TMC114 etanolato
Product Code: TMC114
Pharmaceutical Form: Coated tablet
INN or Proposed INN: DARUNAVIR
Current Sponsor code: TMC114
Concentration unit: mg milligram(s)
Concentration ty
Sponsors
JANSSEN-CILAG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ·Patients with documented HIV-1 infection. ·Male or female aged > 18 years old. ·Patients who have voluntarily provided signed and dated consent forms. ·Patients have been receiving HAART for at least 24 weeks. ·Patients are currently on their first-line treatment and this is HAART. Note: HAART is defined as the combination of 2 NRTIs with at least 1 additional ARV from the NNRTI and/or PI class*. A first line regimen with 3 NRTIs is allowed. ·Plasma HIV-1 RNA 100/mm3 at the start of HAART and > 200/mm3 at screening. 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: ·History of coronary heart disease, (history of myocardial infarction, coronary bypass surgery, coronary angioplasty, or angina pectoris with a positive stress test or angiographic documentation), uncontrolled hypertension (systolic blood pressure >160 or diastolic blood pressure >100 mmHg) peripheral vascular disease (claudication, angioplasty, or bypass procedure), or cerebrovascular disease (stroke or TIA with documented carotid or aortic atherosclerosis). ·Pregnant or breast-feeding ·Any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study ·History of virological failure on HAART. ·History of plasma HIV-1 RNA > 500 copies/ml after initial full virological suppression while on ARV therapy. ·Patients with clinical or laboratory evidence of significantly decreased hepatic function or decompensation, irrespective of liver enzyme levels (liver insufficiency). ·Patients diagnosed with acute viral hepatitis at screening. ·Patients co-infected with hepatitis B. Note: Patients co-infected with chronic hepatitis C will be allowed to enter the trial if their condition is clinically stable and is not expected to require treatment during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the change in brachial artery flow mediated vasodilation (FMD) from baseline to week 24 and 48 in the two study arms (DRV/r monotherapy versus a triple combination therapy containing DRV/r and 2 NRTIs).;Primary end point(s): The primary parameter of the study is the change in brachial artery FMD from baseline to week 24. Brachial artery FMD is calculated as the percentage increase in brachial artery diameter with hyperemia induced relative to the resting brachial artery diameter.;Secondary Objective: ·To evaluate and compare the efficacy of a treatment simplification by a DRV/r monotherapy versus a triple combination therapy with DRV/r in HIV-infected patients at 48 weeks. ·To compare the change in circulating endothelial cells and of their precursors from baseline to week 48 ·To compare the change in mean LDL-cholesterol, HDL-cholesterol, triglycerides , HOMA-IR and Frammingham risk score from baseline to week 24 and 48 in the two study arms ·To compare body fat changes by means of leg fat content analyzed in DEXA and visceral fat content in abdomen TC in the two study arms from baseline to week 48 ·To compare the measure of drug toxicity on mtDNA, (quantified as the amount of mtDNA per cell in isolated CD4+ T cells) and soluble factors involved in mitochondrial/metabolic alterations (leptin, adiponectin); from baseline to week 48 in the two study arms ·To compare lumbar and femoral neck T-score from baseline to week 48 | — |
Countries
Italy
Outcome results
None listed