A randomized, double-blind trial of half versus standard dose of zidovudine plus zalcitabine in Thai HIV-1-infected patients (study HIV-NAT 001). HIV Netherlands Australia Thailand Research Collaboration.

BACKGROUND: Triple combination antiretroviral therapy, recommended as standard of care, is unaffordable for much of the developing world. OBJECTIVES: To establish whether half doses of zidovudine (AZT) and zalcitabine (ddC) are as effective as standard doses in a Thai population with lower body weight than Western populations and predominantly infected with HIV-1 subtype E. METHODS: A group of 116 antiretroviral naive patients, with CD4 cell counts 100-500 x 10(6) cells/l, were randomized to: AZT 200 mg three times daily plus ddC 0.75 mg three times daily versus AZT 100 mg three times daily plus ddC 0.375 mg three times daily and followed-up regularly for 48 weeks. RESULTS: The study enrolled 111 patients: 59 men and 52 women, body weight (mean +/- standard deviation) 56.4 +/- 12.3 kg, mean CD4 cell count 324 x 10(6) cells/l, mean HIV RNA 4.7 log10 copies/ml. There were no significant differences between the two groups. Twelve patients discontinued, including two deaths that were unrelated to study medication. No significant differences in adverse events were seen. Week 48 data for the standard dose and half dose arms, respectively, were mean CD4 cell count increases of 52 and 78 x 10(6) cells/l (P = 0.34), mean plasma HIV-1 RNA reduction of 1.4 and 1.1 log10 copies/ml (P = 0.10), HIV RNA of < 400 copies/ml in 52 and 20%[ (P = 0.001). Participants with higher than mean baseline CD8 cell counts (mean 1062 x 10(6) cells/l) showed greater decline in CD8 cells on standard doses. Further analysis showed improved reduction in HIV RNA (P < 0.0001) and in the percentage with undetectable HIV RNA (P = 0.0137) in the standard dose arm, corrected for baseline HIV RNA, which if < 4.75 log10 copies/ml significantly correlated with HIV RNA < 400 copies/ml at week 48. CONCLUSION: At week 48, the proportion with HIV RNA < 400 copies/ml was significantly higher in the standard dose arm; lower baseline HIV RNA correlated with better HIV RNA outcome at 48 weeks. The arms did not differ in CD4 cell response but standard doses correlated with greater CD8 cell decline.

Meta-analysis of the effects of soy protein intake on serum lipids.

BACKGROUND: In laboratory animals, the consumption of soy protein, rather than animal protein, decreases serum cholesterol concentrations, but studies in humans have been inconclusive. In this meta-analysis of 38 controlled clinical trials, we examined the relation between soy protein consumption and serum lipid concentrations in humans. METHODS: We used a random-effects model to quantify the average effects of soy protein intake on serum lipids in the studies we examined and used hierarchical mixed-effects regression models to predict variation as a function of the characteristics of the studies. RESULTS: In most of the studies, the intake of energy, fat, saturated fat, and cholesterol was similar when the subjects ingested control and soy-containing diets; soy protein intake averaged 47 g per day. Ingestion of soy protein was associated with the following net changes in serum lipid concentrations from the concentrations reached with the control diet: total cholesterol, a decrease of 23.2 mg per deciliter (0.60 mmol per liter); 95 percent confidence interval, 13.5 to 32.9 mg per deciliter [0.35 to 0.85 mmol per liter]), or 9.3 percent; low-density lipoprotein (LDL) cholesterol, a decrease of 21.7 mg per deciliter (0.56 mmol per liter); 95 percent confidence interval, 11.2 to 31.7 mg per deciliter [0.30 to 0.82 mmol per liter]), or 12.9 percent; and triglycerides, a decrease of 13.3 mg per deciliter (0.15 mmol per liter; 95 percent confidence interval, 0.3 to 25.7 mg per deciliter [0.003 to 0.29 mmol per liter]), or 10.5 percent. The changes in serum cholesterol and LDL cholesterol concentrations were directly related to the initial serum cholesterol concentration (P < 0.001). The ingestion of soy protein was associated with a nonsignificant 2.4 percent increase in serum concentrations of high-density lipoprotein (HDL) cholesterol. CONCLUSIONS: In this meta-analysis we found that the consumption of soy protein rather than animal protein significantly decreased serum concentrations of total cholesterol, LDL cholesterol, and triglycerides without significantly affecting serum HDL cholesterol concentrations.

Anemia and iron status in the free-living and institutionalized elderly in Kentucky.

A study of the iron status and anemia in 101 elderly persons, age 60 to 95, included 50 free-living and 51 institutionalized subjects. Daily iron intakes and biochemical parameters including hemoglobin, hematocrit, mean corpuscular hemoglobin concentration (MCHC), plasma iron levels and total iron binding capacity (TIBC) were determined. In the free-living group, only 4% male and 8% female subjects had iron-deficiency anemia. Whereas about 40% of the institutionalized group had iron deficiency anemia with low hemoglobin, hematocrit, MCHC, plasma iron levels, and elevated TIBC. Hemoglobin, hematocrit, MCHC and plasma iron levels were significantly higher, and TIBC was significantly lower in the free-living group than the institutionalized group. The lack of correlation between dietary iron intakes and plasma iron levels suggest that iron deficiency anemia in these elderly subjects was not due to lack of iron intakes. The possible causes might be medications and diseases in these elderly subjects.

Survey of drug use by the elderly and possible impact of drugs on nutritional status.

The drug consumption of institutionalized and noninstitutionalized elderly in the central Kentucky area was surveyed. The 259 subjects above age 60 were randomly selected and consisted of 122 institutionalized and 137 noninstitutionalized subjects. Individual data on age, sex, drug intake, dosage, and health status were recorded. The drugs taken were categorized by their pharmacological action, and the number of subjects on each drug was recorded. Institutionalized elderly subjects had a significantly higher drug intake (average 5.2 drugs a day) than noninstitutionalized elderly subjects (average 1.6 drugs a day). A consistent increase was found in the average number of drugs used with increasing age. The results also showed that the medications most frequently used were drugs used for cardiovascular disease, for the central nervous system, and for constipation. Aspirin and Tylenol were also commonly used. Institutionalized elderly subjects had especially high intakes of these drugs. The possible impact of these drugs on the nutritional status of the elderly was discussed. Some medications for long-term use may exert serious adverse effects on the nutritional status.

Testis tumors associated with congenital adrenal hyperplasia: a continuing diagnostic and therapeutic dilemma.

A 9-year-old boy with documented congenital adrenal hyperplasia owing to a deficiency in C21 hydroxylation is described. Precocious virilization and testicular asymmetry were noted when he was 5 years old. Both of these conditions persisted despite progressively larger doses of replacement steroid therapy. The right testis was 3 times larger than the left testis and serum testosterone was well within the adult male range. A right inguinal orchiectomy was performed. Pathologic diagnosis was interstitial cell tumor. A review of the literature emphasizes the continuing dilemma of separating interstitial cell tumors from hypertrophy of adrenal rest tissue in the presence of congenital adrenal hyperplasia. Possible methods of distinction are discussed.