ABSTRACT
OBJECTIVE: The primary aim of the study was to compare the metabolic side effects of a nucleoside analogue-containing regimen with a nucleoside analogue-sparing double protease inhibitor regimen. A secondary goal was to test for efficacy of a double-PI regimen. DESIGN: Multicenter, randomized, open-label, phase III clinical trial. SUBJECTS: Adult HIV-1-infected individuals naïve to antiretroviral therapy with viral load above 400 HIV-RNA copies/ml were randomized (1:1) to either 400 mg lopinavir /100 mg ritonavir (LPV/r) BID plus 150 mg lamivudine/300 mg zidovudine (CBV) BID versus LPV/r BID plus 300 mg atazanavir (ATV) QD. Main outcome measure was the virologic failure in both groups, defined as viral load ≥50 copies/ml at week 48. RESULTS: In the CBV/LPV/r-arm, 29 out of 35 patients [(83%; 95% confidence interval (CI) 66.9-92.2%] and 18 out of 40 patients (45%; 95% CI 29.7-61.5%) in the ATV/LPV/r-arm had a HIV-RNA level <50 copies/ml at week 48. The intent-to-treat analysis revealed inferior virologic response in the ATV/LPV/r arm (Chi-Q and Fisher´s Exact Test p<0.001) and resulted in premature termination of the trial. Eleven patients in the ATV/LPV/r-arm discontinued therapy because of virological failure. These failures mostly presented with low level replication (<1,000 copies/ml). Increases in CD4 cell counts was significantly more rapid in the ATV/LPV/r arm (p=0.02), but comparable at week 48. CONCLUSIONS: ATV/LPV/r had less virologic efficacy than the conventional RTI-based regimen and resulted in a high virological failure rate with low level replication.
ABSTRACT
OBJECTIVE: To study the prevalence of vitamin B(6) deficiency in common variable immunodeficiency and the impact of vitamin B(6) supplementation on immune function in the disorder. DESIGN: Open, non-blinded. SETTING: Medical School Hannover, Hannover, Germany. SUBJECTS: Plasma vitamin B(6) concentrations were measured in all the 54 common variable immunodeficiency (CVID) patients visiting our outpatients' clinics in 2005. INTERVENTIONS: The 17 patients with a decreased vitamin B(6) concentration were recommended to take 50 mg of vitamin B(6)/day for 3 months. Then, vitamin B(6) concentrations, absolute number of lymphocyte populations and immunoglobulin concentrations were controlled. RESULTS: Vitamin B(6) concentrations were reduced in 17/54 patients. All 11/17 patients following our advice to substitute vitamin B(6) had normal vitamin B(6) plasma concentrations 3 months later. In parallel, the number of CD4(+) T cells significantly increased. In contrast, concentrations of serum immunoglobulins were not improved. CONCLUSIONS: Vitamin B(6) deficiency is common in CVID. The vitamin deficiency is not the cause of CVID and vitamin supplementation does not relieve humoral immunodeficiency. Nevertheless, vitamin B(6) should be measured in CVID to avoid possible long-term complications of its deficiency.
