Suchergebnisse

Novel strategies with NRTIs‐sparing regimen in antiretroviral naïve HIV‐infected patients are currently used in clinical trials [1]. We previously presented preliminary results of this study [2] and here we present the 48‐weeks final results. Prospective, open‐label, randomised (1:1), multicenter, proof‐of‐concept trial. HIV‐infected naïve patients were assigned to once daily maraviroc (MVC) plus lopinavir/ritonavir (LPV/r) or to tenofovir/emtricitabine (TDF/FTC) plus LPV/r. Objectives of the study were the 48‐weeks virological and immunological efficacy. Data were collected at baseline (BL) and at 4, 12, 24, 36 and 48 weeks. T cell subsets from frozen peripheral blood mononuclear cells collected at BL, 4 and 48 weeks were also evaluated. ANOVA for repeated measures performed and Greenhouse‐Geisser probabilities calculated. Results reported as median (Q1–Q3) or frequency (%). Fifty patients (26 in MVC group and 24 in TDF/FTC group) were enrolled and reached week 48. Similar BL characteristics were observed in the two study groups; age: 39.1 (34.2–44) years, 2/50 (4%) females, infected since 2.9 (0.8–5.3) years, CD4+ nadir 266 (242–315) cells/µL, BL CD4+ 295 (260–369) cells/µL; CD4% 18.6 (14.6–23), HIV‐RNA 4.4 (3.9–4.8) log10 copies/mL. At W48, all patients in MVC group and 22/24 (96%) in TDF/FTC group had HIV‐RNA<50 copies/ml (p=0.225). CD4+ trend during follow‐up was different between the two groups (p=0.046) with a higher CD4 gain of 286 (183–343) vs 199 (125–285) cells/mL in MVC and TDF/FTC, respectively (p=0.033). In MVC vs TDF/FTC group, we observed a higher expression of CCR5+CD4+ T cells [W48 change: +7.5% (−4.5/11) vs −5.4 (−15.1/−0.5), p=0.016] and a higher increase of CD4+ effector memory [W48 change: +1.6% (0.7/4.8) vs ‐4.4 (−13.5/−0.2), p=0.007]. No significant variations in naïve and central memory CD4+ T cells. Treatment was well tolerated, without grade 3 or 4 adverse events. No significant difference between the two groups as for the 48‐weeks trend of bone marrow function, AST, ALT and CPK values, creatinine value, glicyde profile (fasting glucose, fasting insuline) and lipid profile (total cholesterol, LDL and HDL cholesterol, tryglicerides). Results are shown in Table 1. In naïve‐patients, virological efficacy and tolerability of a NRTIs‐sparing regimen with maraviroc and lopinavir/ritonavir was similar to conventional treatment in addition to a better immunological recovery, in particular of the Effector Memory CD4+ cells subset.















Baseline
Week 12
Week 24
Week 36
Week 48
p‐valuea




CD4+ cells/mm3
MVC+LPV/r
292 (261–359)
438 (381–500)
517 (432–620)
533 (457–682)
614 (455–709)
0.046



TDF/FTC+LPV/r
297 (257–373)
450 (354–511)
496 (367–568)
470 (402–568)
505 (419–705)



CD4%
MVC+LPV/r
19.5 (16.3–24.3)
24 (18–29.5)
26.2 (22.2–29)
28.2 (21.3–32.2)
27.7 (21.6–33)
0.718



TDF/FTC+LPV/r
18.8 (14.3–22.3)
24.7 (18.4–26.2)
25.2 (21.3–30.1)
24.9 (21.5–31.6)
25.7 (22.1–30.2)



CD4/CD8 ratio
MVC+LPV/r
0.35 (0.25–0.48)
0.45 (0.3–0.62)
0.54 (0.4–0.67)
0.66 (0.4–0.82)
0.72 (0.47–0.93)
0.316



TDF/FTC+LPV/r
0.33 (0.26–0.4)
0.44 (0.33–0.55)
0.51 (0.39–0.66)
0.52 (0.48–0.7)
0.54 (0.49–0.72)



HIV‐RNA log10 copies/ml
MVC+LPV/r
4.42 (4.07–4.84)
1.56 (1.56–1.56)
1.56 (1.56–1.56)
1.56 (1.56–1.56)
1.56 (1.56–1.56)
0.188



TDF/FTC+LPV/r
4.41 (3.84–4.76)
1.56 (1.56–1.56)
1.56 (1.56–1.56)
1.56 (1.56–1.56)
1.56 (1.56–1.56)



Haemoglobin (g/dL)
MVC+LPV/r
14.7 (13.7–15.1)
14 (13.5–14.6)
14.3 (13.7–14.9)
14.1 (13.3–15.1)
14.5 (13.6–15.2)
0.357



TDF/FTC+LPV/r
14.1 (13.8–14.9)
14.4 (13.5–15.1)
14.8 (13.5–15.3)
14.7 (13.7–15.3)
14.7 (13.6–15.2)



White blood cell (109/mm3)
MVC+LPV/r
5 (4.6–5.6)
5.6 (5.2–6.9)
5.8 (4.8–7.2)
5.9 (5–7.7)
5.9 (5–7.5)
0.806



TDF/FTC+LPV/r
4.5 (3.9–5.2)
4.3 (4.3–6.5)
5.1 (4.5–7.1)
5.1 (4.3–6.8)
5.5 (4.4–6.7)



Cholesterol (mg/dl)
MVC+LPV/r
178 (149–204)
–
202 (177–233)
–
218 (167–260)
0.794



TDF/FTC+LPV/r
160 (144–194)
–
189 (157–239)
–
199 (164–239)



Tryglicerides (mg/dl)
MVC+LPV/r
91 (64–126)
–
193 (113–254)
–
170 (105–270)
0.825



TDF/FTC+LPV/r
91 (66–148)
–
159 (106–203)
–
147 (110‐187)



Glucose (mg/dl)
MVC+LPV/r
84 (78–91)
–
86 (75–89)
–
84 (76–93)
0.200



TDF/FTC+LPV/r
81 (75–89)
–
85 (79–92)
–
82 (77–88)



Insulin (U/L)
MVC+LPV/r
5.7 (4–10.2)
–
7 (5.1–8.4)
–
6.8 (5.8–10.8)
0.554



TDF/FTC+LPV/r
7.2 (5.7–14.6)
–
6.8 (5.7–10)
–
5.8 (5.3–9.3)



Creatinine (mg/dl)
MVC+LPV/r
0.83 (0.77–0.95)
0.79 (0.72–0.85)
0.78 (0.69–0.87)
0.78 (0.71–0.86)
0.81 (0.75–0.87)
0.149



TDF/FTC+LPV/r
0.83 (0.78–0.98)
0.88 (0.79–1)
0.85 (0.75–0.93)
0.85 (0.77–0.92)
0.85 (0.74–0.95)

7‐11 November 2010, Tenth International Congress on Drug Therapy in HIV Infection, Glasgow, UK

We felt the urgency to launch the EU2Cure Consortium to support research and find a cure for the human immunodeficiency virus (HIV) infection through intensified collaboration within Europe. This consortium is open to stakeholders on cure in Europe from academia and the community to connect. The aim of this consortium is to intensify the research collaboration amongst European HIV cure groups and the community and facilitate interactions with other academic and community cure consortia, private parties, and policy makers. Our main aim is to create a European research agenda, data sharing, and development of best practice for clinical and translational science to achieve breakthroughs with clinically feasible HIV cure strategies. This consortium should also enable setting up collaborative studies accessible to a broader group of people living with HIV. Besides reservoir studies, we have identified three overlapping scientific interests in the consortium that provide a starting point for further research within a European network: developing "shock and kill" cure strategies, defining HIV cure biomarkers, and connecting cure cohorts. This strategy should aid stakeholders to sustain progress in HIV cure research regardless of coincidental global health or political crises.

We felt the urgency to launch the EU2Cure Consortium to support research and find a cure for the human immunodeficiency virus (HIV) infection through intensified collaboration within Europe. This consortium is open to stakeholders on cure in Europe from academia and the community to connect. The aim of this consortium is to intensify the research collaboration amongst European HIV cure groups and the community and facilitate interactions with other academic and community cure consortia, private parties, and policy makers. Our main aim is to create a European research agenda, data sharing, and development of best practice for clinical and translational science to achieve breakthroughs with clinically feasible HIV cure strategies. This consortium should also enable setting up collaborative studies accessible to a broader group of people living with HIV. Besides reservoir studies, we have identified three overlapping scientific interests in the consortium that provide a starting point for further research within a European network: developing "shock and kill" cure strategies, defining HIV cure biomarkers, and connecting cure cohorts. This strategy should aid stakeholders to sustain progress in HIV cure research regardless of coincidental global health or political crises.

We felt the urgency to launch the EU2Cure Consortium to support research and find a cure for the human immunodeficiency virus (HIV) infection through intensified collaboration within Europe. This consortium is open to stakeholders on cure in Europe from academia and the community to connect. The aim of this consortium is to intensify the research collaboration amongst European HIV cure groups and the community and facilitate interactions with other academic and community cure consortia, private parties, and policy makers. Our main aim is to create a European research agenda, data sharing, and development of best practice for clinical and translational science to achieve breakthroughs with clinically feasible HIV cure strategies. This consortium should also enable setting up collaborative studies accessible to a broader group of people living with HIV. Besides reservoir studies, we have identified three overlapping scientific interests in the consortium that provide a starting point for further research within a European network: developing "shock and kill" cure strategies, defining HIV cure biomarkers, and connecting cure cohorts. This strategy should aid stakeholders to sustain progress in HIV cure research regardless of coincidental global health or political crises.