Bariatric surgery in individuals with human immunodeficiency virus and type 2 diabetes: a case series.

BACKGROUND: The efficacy and safety of bariatric surgery have not been fully elucidated in patients affected with human immunodeficiency virus. Although adjustable gastric banding and sleeve gastrectomy are starting to be used in patients with human immunodeficiency virus, there are limited descriptions of the outcomes of type 2 diabetes mellitus in individuals who are human immunodeficiency virus positive and undergoing these procedures. CASE PRESENTATION: We have evaluated retrospectively three patients who underwent adjustable gastric banding or sleeve gastrectomy, the effect in weight reduction and glycemic control as well as its impact on human immunodeficiency virus management. Case 1 (adjustable gastric banding), a 58-year-old Caucasian male, achieved 19% total weight loss, Case 2, a 33-year-old Caucasian male (sleeve gastrectomy) lost 25%, and Case 3, a 48-year-old Caucasian female (sleeve gastrectomy), lost 14% postoperation. In terms of type 2 diabetes mellitus, Case 2 achieved complete remission according to American Diabetes Association criteria, while Case 1 would also have achieved remission were it not for the continuation of metformin postoperatively. Insulin requirements and pill burden were markedly reduced in Case 3 after sleeve gastrectomy, although lack of remission was predictable given the longevity of type 2 diabetes mellitus and preoperative insulin dosage. In all three cases, human immunodeficiency virus status did not appear to be affected by the bariatric surgery which was supported by the postoperative stable CD4 count and undetectable viral load. CONCLUSIONS: Bariatric surgery is a safe and effective treatment modality in patients who are human immunodeficiency virus positive with obesity and type 2 diabetes mellitus.

Prevention of atherosclerosis in patients living with HIV.

INVESTIGATIONAL PRODUCT: Rosuvastatin (Crestor; Astra Zeneca). ACTIVE INGREDIENTS: Rosuvastatin (5 mg). STUDY TITLE: Prevention of Atherosclerosis in Patients Living with HIV. PHASE OF STUDY: Phase III. AIMS: PRIMARY AIM: To assess whether rosuvastatin therapy could slow the progression of the carotid intima-media thickness (C-IMT; as measured by the change in the mean IMT of the near and far walls of the distal common carotid arteries) over 2 years in HIV-infected patients (HIV-IP). SECONDARY AIMS: To assess whether rosuvastatin therapy could reduce highly sensitive C reactive protein (hs-CRP) inflammatory marker that is increased in HIV-IP.To assess the effect of rosuvastatin therapy on serum lipid levels (total cholesterol [TC], low-density lipoprotein [LDL] cholesterol, high-density lipoprotein [HDL] cholesterol and triglycerides [TG]) and apolipoproteins (APO A1, APO B and APO B/A1).To assess the safety of rosuvastatin in HIV-IP through the evaluation of clinical laboratory analyses (liver function tests and creatine kinase) and adverse events (AEs). STUDY DESIGN: Two-year randomized, double-blind, placebo-controlled, parallel group study. PLANNED SAMPLE SIZE: 320 HIV-IP. SUMMARY OF ELIGIBILITY CRITERIA: HIV-IP who are aged between 30 and 60 years, with a CD4 count. greater than 200 cells/mm(3). Patients must be stable on combination antiretroviral therapy (cART) for at least 12 months and have a 10-year CVD risk of less than 20% (using the Framingham risk score). NUMBER OF STUDY CENTERS: One. DURATION OF TREATMENT: Two years (5 mg rosuvastatin or placebo once daily). DOSE AND ROUTE OF ADMINISTRATION: Oral rosuvastatin (5 mg) once daily. The incidence of cardiovascular disease (CVD) in HIV-IP is at least three times higher than in the general population and further increases each year with combination anti-retroviral therapy (cART). The carotid atherosclerosis progression rate is 10 times higher in HIV-IP than in uninfected individuals. The aim of this study is to assess whether therapy with 5 mg rosuvastatin could: 1) Slow the progression in the mean IMT of the distal common carotid arteries over two years in HIV-IP.2) Change the concentration in the inflammatory marker--hs-CRP, which is increased in HIV-IP.3) Change the concentrations of TC, LDL cholesterol, HDL cholesterol, TG, apolipoproteins (APO) B, APO A1 and APO B/A1.4) Be administered safely in the study population. Pharmacological intervention with rosuvastatin will be evaluated in a double-blind, placebo-controlled, randomized clinical trial in HIV-IP treated with cART not matching the published selection criteria for lipid-lowering therapy. For the first time, this study will investigate anti-inflammatory and anti-atherogenic effects of a pharmacological lipid-lowering agent in HIV-IP that may lead to the reduction of CVD.