Infection of HIV MedDRA version: 9.1 Level: PT Classification code 10020161
Conditions
Interventions
Trade Name: CELSENTRI
Pharmaceutical Form: Coated tablet
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Trade Name: PREZISTA
Pharmaceutical Form: Coated tabl
Sponsors
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients receiving at least three antiretroviral drugs (ritonavir is not considered in the 3) unchanged for at least 12 weeks Aged greater or equal to18 years old who will sign the informed consent. With viremia 200 cells/mm3 for at least 3 months and absence of major active opportunistic infections or other AIDS-defined diseases for at least one year prior to the screening. With R5 viral tropism predicted on the basis of the interpretation of the sequence of the V3 region of viral DNA and other clinical parameters according to geno2pheno ``clonal`` Who provided informed consent to participate in 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: Pregnancy or breast-feeding, the desire for short-term pregnancy The presence of major non AIDS-defined diseases that, in the opinion of the investigator may compromise the stay of the patient in the study for the necessary follow-up period. Presence of at least one major resistance mutation or two minor resistance mutations that can reduce the susceptibility to darunavir according to the latest updated list of the International AIDS Society - USA, documented in the last or previous resistance testing. Past exposure to CCR5 antagonist drugs. Past determination of plasmatic tropism indicating strains D/M or X4 Previous major clinical toxicities (grade >=3) to the proposed drugs of the study (darunavir; ritonavir at a dosage <300 mg/die) or those currently in use History of allergy to sulphonamides Positivity for HBsAg Hepatic cirrhosis with Child-Pugh C class Estimated glomerular filtration < 30 ml/min (Cockroft-Gaut; MDRD if African-black or african-american) at screening visit Ipertransaminemia of grade IV (more than 10 times the upper normal limit) at screening visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the non virological inferiority at 48 weeks of therapeutic simplification to maraviroc (MVC) QD + darunavir/ritonavir (DRV/r) QD compared to the prosecution of the previous treatment in patients with tropic R5-virus, who are treated with at least 3 ARV, who have a toxicity of any grade and type with the current therapy or wish a therapeutic simplification or a proactive NRTI interruption and have a persistent virological suppression in the last 24 weeks.;Secondary Objective: Verify and compare the trend of immunological and toxicity parameters between the two randomized arms and the impact in pharmaco-economic terms of the proposed simplification;Primary end point(s): percentage of patients with virological failure (defined as 2 HIV-RNA consecutive values above 50 copies/mL or a single value above 1000 copies/mL) (TLOVR) at 48 weeks according to the analysis for protocol switch=failure. Switch=suspension or addition of any drug in the MVC+DRV/r arm; idem in the control arm. | — |
Countries
Italy
Outcome results
None listed