The National Marrow Donor Program has benefited a substantial number of patients in need of marrow transplants from closely HLA-matched unrelated donors and has facilitated the recruitment of unrelated donors into the donor pool and the access to suitable marrow.

The Minnesota Coronary Survey was a 4.5-year, open enrollment, single end-time, double-blind, randomized clinical trial that was conducted In six Minnesota state mental hospitals and one nursing home. It Involved 4393 Institutionalized men and 4664 Institutionalized women. The trial compared the effects of a 39% fat control diet (18% saturated fat, 5% polyunsaturated fat, 16% monounsaturated fat, 446 mg dietary cholesterol per day) with a 38% fat treatment diet (9% saturated fat, 15% polyunsaturated fat, 14% monounsaturated fat, 166 mg dietary cholesterol per day) on serum cholesterol levels and the Incidence of myocardlal Infarctions, sudden deaths, and all-cause mortality. The mean duration of time on the diets was 384 days, with 1568 subjects consuming the diet for over 2 years. The mean serum cholesterol level In the pre-admission period was 207 mg/dl, falling to 175 mg/dl in the treatment group and 203 mg/dl In the control group. For the entire study population, no differences between the treatment and control groups were observed for cardiovascular events, cardiovascular deaths, or total mortality. A favorable trend for all these end-points occurred In some younger age groups. (Arteriosclerosis 9:129-135, January/February 1989) T he institutions chosen for the trial were the Minnesota state mental hospitals at Anoka, Fergus Falls, Hastings, Moose Lake, St. Peter, and Willmar and the nursing home at Oak Terrace. Before initiation of the experimental phase, the populations were observed for a 3-year period, during which their suitability for a long-term dietary trial was studied. The feeding program began in the Willmar State Hospital in November, 1968. The program was phased in to the other institutions in succession over the following 15 months. The trial was an outgrowth of the National Diet-Heart Feasibility Study. 1 Methods Ethical ConsiderationsThe project was approved by the Clinical Research Committee of the University and, after extensive discussion with the relevant institutional committees, by each of the collaborating hospitals. No consent forms were required on the grounds that the two diets were both acceptable as house diets and the tests all contributed to better patient care. Before initiation of the study in each hospital, all the residents and staff were invited to a meeting at which the investigators explained the project. Samples of the foods were served at these meetings. There was a question and Received March 25,1987; revision accepted August 30,1988. answer period, and the residents were invited to make appointments for one-to-one further explanations if they wished. They were allowed to decline to participate or to discontinue their participation at any time. Nonparticipants were served the control diet, which was similar to the pre-study institutional diets. Blood was not drawn from nonparticipants, and electrocardiograms were not recorded. Participation was nearly 100% with fewer than a dozen refusals throughout the trial. Experimental PlanThe original population was initially ...

Severe weight loss in HIV is associated with decreased length of survival. It is unclear whether mild weight loss is associated with an increased risk of death or opportunistic complications of HIV. Participants in four interventional studies (n = 2382) conducted by a community-based clinical trials network were evaluated for percentage change in weight during their first 4 months in the study. Proportional hazards models were performed for the occurrence of opportunistic complications and death subsequent to the 4-month visit. The relative risk of death and opportunistic complications for those with 5% to 10% weight loss over 4 months was 2.22 (p < .001) and 1.89 (p < .001), respectively, and 1.26 (p < .01) and 1.19 (p < .01) among those who lost 0% to 5% of their body weight, respectively, when compared with those with no weight loss. Among those who lost 5% to 10% of their body weight, the relative risk of individual opportunistic complications increased significantly, including Pneumocystis carinii pneumonia (PCP) (1.61; p < .01), cytomegalovirus (CMV) (2.33; p < .001), and Mycobacterium avium complex (MAC) (1.81; p < .01). As little as 5%t weight loss over a 4-month period is associated with increased risk of death and opportunistic complications in HIV. A weight loss of 5% to 10% is also associated with an increased risk of individual opportunistic complications.

Long-term follow-up of participants initiating 3 ART strategies demonstrated similar changes in total and regional fat, with no differences by ART strategy. The differential effects on lipid metabolism by strategy and the overall increases in insulin and insulin resistance with all 3 strategies necessitate close monitoring of patients on ART.

Comparisons of body composition and metabolic changes among antiretroviral-naive patients randomly assigned to didanosine and stavudine- (ddI+d4T) vs. abacavir and lamivudine- (ABC+3TC) containing regimens were assessed in a nested substudy of an ongoing multicenter randomized trial. At baseline and every 4 months, body cell mass and total body fat were calculated, anthropometric measurements were performed, and fasting metabolic parameters were obtained. The rates of change (unit/mo) estimated using the slopes of regression lines and overall mean changes from baseline were compared by study assignment. Among 96 patients enrolled, 46 received ddI+d4T- and 50 received ABC+3TC-containing regimens with a median follow-up of 32.4 months. For both study arms, an overall increase in the rates of change was seen for body cell mass. For ddI+d4T, after an initial increase, the rates of change declined for regional fat and total body fat compared with an increase for ABC+3TC, with the 2 arms being significantly different (P<0.05). For high-density lipoprotein cholesterol rates of change, ddI+d4T decreased, while ABC+3TC increased. For both arms, low-density lipoprotein cholesterol decreased, while triglycerides increased. Early and sustained increases in insulin and insulin resistance were seen only for ddI+d4T. In this prospective study, metabolic and body composition changes varied according to whether subjects received ddI+d4T or ABC+3TC.

No abstract

To benefit maximally from antiretroviral therapy, patients with HIV infection must enter care before their disease is advanced and adhere to care. We sought to determine if and where on this continuum of care racial/ethnic disparities were evident. Data from the Flexible Initial Retrovirus Suppressive Therapies (FIRST) trial, which evaluated three strategies for initial HIV therapy, were compared for White, African American, and Latino subjects. Outcomes included progression of disease and death, HIV viral suppression, and change in CD4(+) cell count. Multivariate Cox proportional hazard models adjusted for known predictors of survival. There were 1357 subjects, including 368 non-Latino white, 751 non-Latino African American, and 238 Latino subjects. At baseline, the two latter groups were more likely to have had AIDS and had lower CD4(+) cell counts than white subjects. In follow-up, African American subjects had lower self-reported adherence to therapy, lower CD4(+) cell count increases, and lower odds of viral suppression. African American and Latino subjects had unadjusted hazard ratios of progression of disease or death of 1.57 (1.17, 2.10; p = 0.0025) and 1.57 (1.09, 2.26; p = 0.02), respectively. Adjusting for baseline differences and differences in adherence, CD4(+) cell count change, and viral suppression accounted for the disparities in outcomes. Opportunities to reduce disparities in outcomes for African American and Latino patients exist along the continuum of HIV care. Efforts to promote access to HIV testing and care and to improve adherence have the potential to reduce racial/ethnic disparities in outcomes of patients with HIV infection.

The selection process in the Multiple Risk Factor Intervention Trial caused relations between risk factors to differ between participants who were randomly assigned into the study and the screening population. Cigarette smoking, blood pressure, and serum cholesterol were moderately inversely related to each other in the randomly assigned population whereas these relations in the unselected population were direct and small in magnitude. This problem was addressed by covariate adjustment in analyses. The selection process also created an artificially high initial mean concentration of serum cholesterol; the mean plasma concentration at the second screening was 15 mg/dL lower than at the first screening. Most of this difference is attributable to regression to the mean. To account for this problem, emphasis was placed on change in plasma cholesterol over time, calculated from the second-screening measurement. Examination of the reliability of nutrition data based on one 24-h dietary recall showed that nutrient-biochemical relations are subject to considerable regression-dilution bias. The ratios of "within" to "between" components of variability were typically between one and four. Analyses in which multiple follow-up measures were averaged are emphasized in this monograph. Men assigned to the special intervention group reported considerable reductions in total energy intake, which was not consistent with observed weight loss. The most likely explanation for this is underreporting or underconsumption the day before the recall. To partially adjust for this, nutrient data are often expressed both in absolute units and as nutrient densities.