A phase I trial of paclitaxel, cisplatin, and veliparib in the treatment of persistent or recurrent carcinoma of the cervix: an NRG Oncology Study (NCT#01281852).

Background: Preclinical studies demonstrate poly(ADP-ribose) polymerase (PARP) inhibition augments apoptotic response and sensitizes cervical cancer cells to the effects of cisplatin. Given the use of cisplatin and paclitaxel as first-line treatment for persistent or recurrent cervical cancer, we aimed to estimate the maximum tolerated dose (MTD) of the PARP inhibitor veliparib when added to chemotherapy. Patients and methods: Women with persistent or recurrent cervical carcinoma not amenable to curative therapy were enrolled. Patients had to have received concurrent chemotherapy and radiation as well as possible consolidation chemotherapy; have adequate organ function. The trial utilized a standard 3 + 3 phase I dose escalation with patients receiving paclitaxel 175 mg/m2 on day 1, cisplatin 50 mg/m2 on day 2, and escalating doses of veliparib ranging from 50 to 400 mg orally two times daily on days 1-7. Cycles occurred every 21 days until progression. Dose-limiting toxicities (DLTs) were assessed at first cycle. Fanconi anemia complementation group D2 (FANCD2) foci was evaluated in tissue specimens as a biomarker of response. Results: Thirty-four patients received treatment. DLTs (n = 1) were a grade 4 dyspnea, a grade 3 neutropenia lasting ≥3 weeks, and febrile neutropenia. At 400 mg dose level (DL), one of the six patients had a DLT, so the MTD was not reached. Across DLs, the objective response rate (RR) for 29 patients with measurable disease was 34% [95% confidence interval (CI), 20%-53%]; at 400 mg DL, the RR was 60% (n = 3/5; 95% CI, 23%-88%). Median progression-free survival was 6.2 months (95% CI, 2.9-10.1), and overall survival was 14.5 months (95% CI, 8.2-19.4). FANCD2 foci was negative or heterogeneous in 31% of patients and present in 69%. Objective RR were not associated with FANCD2 foci (P = 0.53). Conclusions: Combining veliparib with paclitaxel and cisplatin as first-line treatment for persistent or recurrent cervical cancer patients is safe and feasible. Clinical trial information: NCT01281852.

The effect of baseline physical activity on cardiovascular outcomes and new-onset diabetes in patients treated for hypertension and left ventricular hypertrophy: the LIFE study.

OBJECTIVES: Physical activity (PA) is a preventive strategy for cardiovascular disease and for managing cardiovascular risk factors. There is little information on the effectiveness of PA for the prevention of cardiovascular outcomes once cardiovascular disease is present. Thus, we studied the relationship between PA at baseline and cardiovascular events in a high-risk population. DESIGN: A prespecified analyses of observational data in a prospective, randomized hypertension study. SETTING: Losartan Intervention For Endpoint reduction in hypertension (LIFE) study. SUBJECTS: Hypertension and left ventricular hypertrophy (LVH) (n = 9,193). INTERVENTIONS: Losartan versus atenolol. MAIN OUTCOME MEASURES: Reported level of PA: never exercise, exercise 30 min twice per week at baseline and after a mean of 4.8 years of treatment with losartan- versus atenolol-based therapy. Risk reductions were calculated by level of PA for the primary composite end-point and its components cardiovascular death, stroke and myocardial infarction, and also all-cause mortality and new-onset diabetes. RESULTS: A modest level of PA (>30 min twice per week) was associated with significant reductions in risk for the primary composite end-point [adjusted hazard ratio (aHR) 0.70, P < 0.001) and its components, all-cause mortality (aHR 0.65, P < 0.001), and new-onset diabetes (aHR 0.66, P < 0.001). CONCLUSION: A modest level of self-reported PA (>30 min twice per week) in patients with hypertension and LVH in the LIFE study was associated with significant reductions in risk for the primary composite end-point and its components of cardiovascular death, stroke, and myocardial infarction, all-cause mortality, and new-onset diabetes.

Management of locoregional stage esophageal cancer: a single center experience.

Therapeutic options for locoregional esophageal cancer (EC) include primary surgery, neoadjuvant or definitive chemoradiation and systemic chemotherapy. The role of surgery in these multimodal strategies has recently been debated and definitive chemoradiation is being offered as an alternative to surgery at many centers. We examined our results with multimodal therapy and surgery in this patient population. We conducted a retrospective analysis of 172 patients with locoregional (AJCC stages I-III) EC treated at RPCI between February 14, 1990 and September 20, 2002. Median age was 65 years (range, 36-95); there were 136 male patients. There were 100 regional (stages IIB-III), 69 local (stages I-IIA) and three in situ cases. Initial therapy was either combined modality (n = 122) or single modality (surgery) (n = 50). There was 0%, 30-day, postoperative mortality. Median survival for all patients was 25.3 months and was better for local stage with surgery alone (75 months) than with neoadjuvant (35.7 months) or definitive chemoradiation (19.1 months, P < 0.001). Survival for patients with regional disease treated with surgery alone, neoadjuvant or definitive chemoradiation was 21.5, 24.4 and 11.8 months, respectively (P = not significant). The associations of prognostic factors with overall survival were evaluated using Cox proportional hazards regression analysis and 2-sided Wald's chi-square test. On multivariate analysis, carefully selected patients treated with surgery alone had better outcomes compared with those treated with definitive chemoradiation (P < 0.001). Patients with locoregional esophageal cancer who are eligible for surgical resection either alone or as a part of multimodal therapy may have better outcomes than those treated with non-surgical approaches.

Alcohol consumption and cardiovascular risk in hypertensives with left ventricular hypertrophy: the LIFE study.

The Losartan Intervention For End point reduction in hypertension (LIFE) study showed superiority of losartan over atenolol for reduction of composite risk of cardiovascular death, stroke, and myocardial infarction in hypertensives with left ventricular hypertrophy. We compared hazard ratios (HR) in 4287 and 685 participants who reported intakes of 1-7 and >8 drinks/week at baseline, respectively, with those in 4216 abstainers, adjusting for gender, age, smoking, exercise, and race. Within categories, clinical baseline characteristics, numbers randomized to losartan and atenolol, and blood pressure (BP) lowering were similar on the drug regimens. Overall BP control (<140/90 mmHg) at end of follow-up was similar in the categories. Composite end point rate was lower with 1-7 (24/1000 years; HR 0.87, P<0.05) and >8 drinks/week (26/1000 years; HR 0.80, NS) than in abstainers (27/1000 years). Myocardial infarction risk was reduced in both drinking categories (HR 0.76, P<0.05 and HR 0.29, P<0.001, respectively), while stroke risk tended to increase with >8 drinks/week (HR 1.21, NS). Composite risk was significantly reduced with losartan compared to atenolol only in abstainers (HR 0.81 95% confidence interval, CI (0.68, 0.96), P<0.05), while benefits for stroke risk reduction were similar among participants consuming 1-7 drinks/week (HR 0.73, P<0.05) and abstainers (HR 0.72, P<0.01). Despite different treatment benefits, alcohol-treatment interactions were nonsignificant. In conclusion, moderate alcohol consumption does not change the marked stroke risk reduction with losartan compared to atenolol in high-risk hypertensives. Alcohol reduces the risk of myocardial infarction, while the risk of stroke tends to increase with high intake.

Type I error in sample size re-estimations based on observed treatment difference.

Sample size re-estimation based on an observed difference can ensure an adequate power and potentially save a large amount of time and resources in clinical trials. One of the concerns for such an approach is that it may inflate the type I error. However, such a possible inflation has not been mathematically quantified. In this paper the mathematical mechanism of this inflation is explored for two-sample normal tests. A (conditional) type I error function based on normal data is derived. This function not only provides the quantification but also gives mathematical mechanisms of possible inflation in the type I error due to the sample size re-estimation. Theoretically, based on their decision rules (certain upper and lower bounds), people can calculate this function and exactly visualize the changes in type I error. Computer simulations are performed to ensure the results. If there are no bounds for the adjustment, the inflation is evident. If proper adjusting rules are used, the inflation can be well controlled. In some cases the type I error can even be reduced. The trade-off is to give up some 'unrealistic power'. We investigated several scenarios in which the mechanisms to change the type I error are different. Our simulations show that similar results may apply to other distributions.

Vitamin supplement use and incident cataracts in a population-based study.

OBJECTIVE: To determine the relationship between vitamin supplement use and the 5-year incidence of nuclear, cortical, and posterior subcapsular cataract in the Beaver Dam Eye Study cohort. DESIGN: The 5-year incidence of cataract, determined from slitlamp (nuclear cataract) and retroillumination (cortical and posterior subcapsular cataract) photographs, was assessed in a population-based cohort of persons participating in baseline (1988-1990) and follow-up (1993-1995) examinations. Detailed data regarding the type, dosage, and duration of supplement use were obtained by in-person interviews at follow-up. PARTICIPANTS: Residents of Beaver Dam, Wis, aged 43 to 86 years, were identified by private census. Of the 3684 participants in both baseline and follow-up examinations, 3089 were eligible for incident cataract analysis in the present study. RESULTS: Compared with nonusers, the 5-year risk for any cataract was 60% lower among persons who, at follow-up, reported the use of multivitamins or any supplement containing vitamin C or E for more than 10 years. Taking multivitamins for this duration lowered the risk for nuclear and cortical cataracts but not for posterior subcapsular cataracts (odds ratios [95% confidence intervals] = 0.6 [0.4-0.9], 0.4 [0.2-0.8], and 0.9 [0.5-1.9], respectively). Use of supplements for shorter periods was not associated with reduced risk for cataract. Measured differences in lifestyle between supplement users and nonusers did not influence these associations, nor did variations in diet as measured in a random subsample. CONCLUSIONS: These data add to a body of evidence suggesting lower risk for cataract among users of vitamin supplements and stronger associations with long-term use. However, the specific nutrients that are responsible cannot be ascertained at this time, and unmeasured lifestyle differences between supplement users and nonusers may explain these results. Arch Ophthalmol. 2000;118:1556-1563

Evaluation of a rapid assay for detection of Chlamydia trachomatis infections in outpatient clinics in South Kalimantan, Indonesia.

A multicenter cross-sectional survey was conducted comparing a commercially available chlamydial optical immunoassay (OIA) to the chlamydial ligase chain reaction (LCR). Endocervical samples from 415 outpatients visiting clinics from three hospitals in South Kalimantan, Indonesia, were evaluated. Relative to the LCR, the overall sensitivity and specificity of the OIA were 31.6 and 98.9%, respectively. The sensitivity of the OIA varied among the three hospital laboratories, ranging from 20 to 50%. The OIA performance was slightly lower on samples from patients attending dermatovenereology clinics than on samples from nondermatovenereology clinic patients. The results indicate that the OIA did not perform well compared to LCR.

Associations between antioxidant and zinc intake and the 5-year incidence of early age-related maculopathy in the Beaver Dam Eye Study.

Associations between antioxidants and zinc and the 5-year incidence of early, age-related maculopathy (ARM) were investigated in a population-based cohort of middle-aged and older adults participating in the Beaver Dam Eye Study in Beaver Dam, Wisconsin. A food-frequency questionnaire was administered at baseline (1988-1990) to collect dietary information for that time period and a period of time 10 years earlier (1978-1980) from a 50 percent random sample of persons participating in this study. The incidence of the specific lesions of larger drusen (>125 microns) and pigmentary abnormalities and the incidence of any ARM were assessed by masked grading of stereoscopic color fundus photographs in 1,709 persons who participated in 5-year follow-up eye examinations. Significant, but modest, inverse associations (p < 0.05) were observed between intakes of pro-vitamin A carotenoids and dietary vitamin E and the incidence of large drusen and between zinc and the incidence of pigmentary abnormalities. No significant inverse associations were found between antioxidant or zinc intake and the incidence of overall early ARM. If ARM, which is characterized by a broad spectrum of lesions, involves a number of different underlying pathophysiologic processes, then associations between specific antioxidants and the incidence of distinct macular lesions may be biologically important. However, because there were too few incident late ARM cases in this cohort, the authors were unable to assess whether antioxidant intake is associated with the progression of early ARM to late-stage macular degeneration. Clinical trials and longer-term prospective studies are needed to elucidate further the impact of antioxidants and zinc on the development and progression of ARM.

Incorporating fat-modified foods into a food frequency questionnaire improves classification of fat intake.

OBJECTIVE: To determine the extent to which incorporating fat-modified foods into a food frequency questionnaire influences the agreement of energy and nutrient estimates with estimates obtained from food records. DESIGN: Subjects completed four 2-day food records at 3-month intervals. At the end of the recording period, a food frequency questionnaire was administered to assess usual daily intake during the preceding year. SUBJECTS/SETTING: One hundred and three subjects selected from a population-based sample of adults participating in the Beaver Dam Eye Study. STATISTICAL ANALYSES PERFORMED: Subjects were categorized into three groups on the basis of their frequency of consumption of fat-modified foods. For each group, correlations were calculated between food record estimates and estimates obtained from the original food frequency questionnaire, the original with a low-fat option, and the fat-modified questionnaire. RESULTS: For persons categorized as high consumers of fat-modified foods, incorporating questions regarding the consumption of these products resulted in higher correlations with food record estimates (original vs fat-modified version) for percentage of energy from total fat (.32 vs .47), saturated fat (.20 vs .41), oleic acid (.32 vs .50), and linoleic acid (.40 vs .46). High consumers differed in several characteristics that could be associated with disease risk (eg, higher ratios of serum total cholesterol to high-density lipoprotein cholesterol). CONCLUSIONS: Failure to account for the consumption of fat-modified foods in epidemiologic studies may result in misclassification of fat exposures. Because patterns of misclassification could be different for those at risk for disease, results of epidemiologic studies could be biased if these foods are excluded. Thus, incorporating fat-modified foods into food frequency questionnaires will improve the ability of researchers to correctly classify fat exposures and to evaluate potentially important relationships between fat intake and disease risk.

Influence of using different sources of carotenoid data in epidemiologic studies.

OBJECTIVE: This study compared distributions of carotenoid intake and diet-serum correlations using two sources of carotenoid data: the US Department of Agriculture-National Cancer Institute (USDA-NCI) carotenoid food composition database and values accompanying the Block-NCI Health Habits and History Questionnaire (HHHQ). DESIGN AND SUBJECTS: A 100-item food frequency questionnaire was used to collect dietary data from 2,152 adults, aged 43 to 85 years, who were participating in the Nutritional Factors in Eye Disease Study, a population-based study designed to evaluate nutritional factors associated with age-related eye disease. Blood samples were collected from a random sample of 400 nonfasting participants in the study. RESULTS: Median carotenoid intakes using HHHQ vs USDA-NCI data were alpha carotene (229 vs 223 micrograms/day), beta carotene (1,321 vs 1,325 micrograms/day), beta cryptoxanthin (72 vs 21 micrograms/day), lutein + zeaxanthin (653 vs 811 micrograms/day), and lycopene (593 vs 1,615 micrograms/day). all paired differences in carotenoid intake were significantly different from zero (Wilcoxon signed-rank, P < .0001). Despite these differences, the two databases similarly ranked individuals according to carotenoid intake: Spearman correlations ranged from .71 (lycopene) to .93 (alpha carotene). Differences between diet-serum correlations (adjusted for energy, body mass index, high density lipoprotein, and total cholesterol) using HHHQ vs USDA-NCI data were minor and not significant (P > .05): alpha carotene (r = .33 vs .32), beta carotene (r = .27 vs .32), beta cryptoxanthin (r = .48 vs .53), lutein+zeaxanthin (r = .28 vs .24), and lycopene (r = .29 vs .25). CONCLUSIONS: Although estimates of carotenoid intake differed significantly, only minor differences in carotenoid rankings and diet-serum correlations were observed using either data source in this population.

Association of zinc and antioxidant nutrients with age-related maculopathy.

OBJECTIVE: To quantify relationships between dietary intake of zinc and antioxidant nutrients and early and late age-related maculopathy (ARM). DESIGN: A retrospective longitudinal cohort design using data pertaining to diets in the past (1978-1980), which were assessed retrospectively using a food frequency questionnaire. SETTING: Beaver Dam, Wis. PATIENTS: A 50% random sample of free-living Beaver Dam Eye Study participants, 43 to 86 years of age (N = 1968). MAIN OUTCOME MEASURE: The presence of early and late ARM determined from fundus photography. RESULTS: People in the highest vs lowest quintiles for intake of zinc from foods had lower risk for early ARM (odds ratio = 0.6, 95% confidence interval, 0.4-1.0, P for trend < .05). This relationship appeared to be stronger for some types of early ARM (increased retinal pigment) than for others. Zinc intake was unrelated to late ARM. However, small numbers (n = 30) of people with this condition limit the ability to draw conclusions about this later stage. Levels of carotenoids were unrelated to early or late ARM. Odds for early ARM were lower in people in the highest vs lowest quintiles for the intake of vitamins C or E. However, these associations were not statistically significant. CONCLUSIONS: The data are weakly supportive of a protective effect of zinc on the development of some forms of early ARM. Prospective studies are needed to further evaluate the potential influence of these and other nutritional factors on different types and stages of age-related macular degeneration.

Human serum carotenoid concentrations are related to physiologic and lifestyle factors.

We examined the concentrations of five carotenoids in the serum and diet of a population-based sample of 400 individuals to determine what physiologic and lifestyle factors were related to serum carotenoid concentrations, how these relationships differed among the carotenoids, and if these relationships reflected differences in carotenoid intake. Lower serum concentrations of alpha-carotene, beta-carotene, beta-cryptoxanthin, and lutein+zeaxanthin generally were associated with male gender, smoking, younger age, lower non-HDL cholesterol, greater ethanol consumption and higher body mass index. Serum lycopene generally was not related to these factors, but lower lycopene levels were associated with older age and lower non-HDL cholesterol. Only the hydrocarbon carotenoids (alpha- and beta-carotene and lycopene) were directly associated with HDL cholesterol. The associations of some factors (gender, age, smoking, and ethanol intake) with serum carotenoids were similar to the associations of these factors with levels in the diet, indicating that serum carotenoids may reflect the influence of these factors on carotenoid intake. Consistent with this notion, correlations between serum and dietary carotenoids did not differ between smokers and nonsmokers. Other factors (HDL and non-HDL cholesterol and body mass index) associated with carotenoids in the serum were not associated with carotenoid intake, indicating that physiologic conditions that affect the absorption, storage, and utilization of carotenoids may influence these associations. These physiologic and behavioral correlates of carotenoids could explain or modify associations of carotenoids with chronic diseases.

Serum antioxidants and age-related macular degeneration in a population-based case-control study.

OBJECTIVE: To investigate relationships between levels of tocopherols and carotenoids in the serum and age-related macular degeneration (ARMD). DESIGN: A nested case-control study within a population-based cohort. PARTICIPANTS: Cases included a sample of subjects with retinal pigment abnormalities with the presence of soft drusen (n = 127) or with late ARMD (geographic atrophy [n = 9]) or neovascular and exudative macular degeneration (n = 31). An equal number of controls (167 pairs) were selected from among participants in the Beaver Dam Eye Study. The controls had no photographic evidence of soft drusen, retinal pigment abnormalities, or late ARMD and were matched with cases for age, sex, and current smoking status. DATA COLLECTION: Presence and severity of ARMD were determined from masked grading of fundus photographs obtained from 1988 to 1990. Levels of individual carotenoids and tocopherols were determined in serum collected at the same time. RESULTS: Average levels of individual carotenoids were similar in cases and controls. Average levels of vitamin E (alpha-tocopherol) were lower in people with exudative macular degeneration (P = .03). However, the difference was no longer statistically significant after controlling for levels of cholesterol in the serum. Persons with levels of lycopene, the most abundant carotenoid in the serum, in the lowest quintile were twice as likely to have ARMD. Levels of the carotenoids that compose macular pigment (lutein with zeaxanthin) in the serum were unrelated to ARMD. CONCLUSIONS: Very low levels of one (lycopene) but not other dietary carotenoids or tocopherols were related to ARMD. Lower levels of vitamin E in subjects with exudative macular degeneration compared with controls may be explained by lower levels of serum lipids.

Dietary fat and age-related maculopathy.

OBJECTIVE: To describe the relationship between type and level of fat in the diet and the prevalence of age-related maculopathy. DESIGN: Retrospective population-based study. SETTING AND PARTICIPANTS: Residents of Beaver Dam, Wis, between the ages of 45 and 84 years, participating in the Beaver Dam Eye Study and Nutritional Factors in Eye Disease Study. DATA COLLECTION: Presence and severity of age-related maculopathy were determined from masked grading of fundus photographs taken from 1988 through 1990. Diets in the past (1978 through 1980) were assessed retrospectively using a food frequency questionnaire during in-person home interviews. RESULTS: Persons with intake of saturated fat and cholesterol in the highest compared with the lowest quintile had 80% and 60% increased odds for early age-related maculopathy, respectively, after adjusting for age and intake of beer. These relationships were not influenced by adjusting for several other potential confounding variables (carotenoid intake, intake of vitamins C or E in supplements, smoking, body mass index, time spent outdoors in the summer, gender, and history of diabetes, hypertension, or cardiovascular disease). Odds ratios for late age-related maculopathy were in similar directions but were not statistically significant. CONCLUSIONS: High intake of saturated fat and cholesterol is associated with increased risk for early age-related maculopathy in the Beaver Dam population. This supports the hypothesis that atherosclerosis or its risk factors are related to age-related maculopathy. Confirmation of this finding in other populations and in prospective studies is needed.

Diet and nuclear lens opacities.

Relations between diet and nuclear opacities in the lens of the eye were investigated in a population-based cohort of middle-aged and older adults who lived in Beaver Dam, Wisconsin. Nuclear sclerosis was assessed from photographs of the lens taken during 1988-1990 in 1,919 persons in the Beaver Dam Eye Study. Diets in the past (1978-1980) were assessed retrospectively with the use of a food frequency questionnaire in home interviews. Relations with intake of foods and nutrients were evaluated using logistic regression analyses. In men, after controlling for age, smoking, and heavy drinking, intakes of numerous nutrients in the highest versus lowest quintile were associated with 40-50 percent reduced odds of more severe nuclear sclerosis. Relations with some nutrients (vitamins A, C, and E, riboflavin, thiamin, niacin) were at least partly explained by previously identified inverse associations with multivitamin use. Relations with other nutrients (folate, alpha-carotene, and dietary fiber) appeared to reflect associations with intake of foods, particularly vegetables. Inverse associations with individual nutrients and foods were often weaker or nonexistent in women. These data indicate that the intake of vitamin supplements (in men and women) and certain foods (particularly in men) may explain associations of several nutrients with risk for nuclear sclerosis.

Serum carotenoids and tocopherols and severity of nuclear and cortical opacities.

PURPOSE: To determine whether higher levels of individual carotenoids and tocopherols in the serum are related to less severe nuclear and cortical opacities within the general population. METHODS: Levels of individual carotenoids and tocopherols in the serum were determined in 400 randomly selected persons aged 50 to 84 years participating in the Nutritional Factors in Eye Disease Study of Beaver Dam, Wisconsin. Severity of nuclear and cortical opacities was assessed from lens slit lamp and retroillumination photographs taken at the same time. Relationships between serum levels of nutrients and prevalence of these opacities were evaluated using logistic regression analysis accounting for known possible confounders. RESULTS: Higher levels of individual or total carotenoids or alpha-tocopherol in the serum were not associated with less severe nuclear or cortical opacities overall. However, associations differed between men and women and within specific population subgroups. A significant trend for lower odds for either type of opacity with increasing levels of beta-carotene in the serum was observed in men. For nuclear sclerosis, this protective association with beta-carotene was found in younger but not older men. Higher levels of three other carotenoids (alpha-carotene, beta-cryptoxanthin, and lutein) in serum were significantly related to lower odds for nuclear sclerosis only in men who smoked. In contrast to these inverse associations observed in some subgroups, higher levels of some carotenoids and alpha-tocopherol often were directly associated with nuclear sclerosis, particularly in women. CONCLUSIONS: Higher levels of carotenoids and tocopherols are not consistently associated with less severe opacities in the general population.

Apparent vertical transmission of human immunodeficiency virus type 1 by breast-feeding in Zambia.

PIP: To evaluate the epidemiologic significance of breastfeeding to the transmission of human immunodeficiency virus (HIV) in a country with a high prevalence of HIV infection, the 1720 seronegative women who delivered at the University Teaching Hospital in Lusaka, Zambia, in a 3- month period in 1987 were enrolled in a longitudinal study. Only 634 (37%) of these women returned for testing at the 1-year follow-up point. Of these, 19 (3%) had become seropositive. The infection was asymptomatic in all 19 women at the time of the 1-year follow-up; however, 5 of these women soon developed generalized persistent adenopathy and 3 had spontaneous abortions during the year in which seroconversion occurred. 30 of the spouses of the women in the study sample were HIV-positive; the relative risk of seroconversion was 3.84 in women with HIV-infected spouses compared to those with HIV-negative spouses. Other significant risk factors for HIV seroconversion included: history of genital ulceration after delivery (relative risk, 15.51), use of a cloth to remove vaginal secretions during intercourse (dry sex) (relative risk, 37.95), and blood transfusion (relative risk, 10.89). 3 infants born to these 19 women also seroconverted; 2 years after seroconversion, only 1 of the 3 infected children was symptomatic (persistent, generalized lymphadenopathy). Other sources of HIV infection 9e.g., scarification, blood transfusions, use of contaminated needles during immunization) aside from breastfeeding were not recorded in these 3 infants. Although there is a high prevalence of HIV infection in Zambia, the health benefits of breastfeeding (in terms of the prevention of mortality from diarrheal disease) still outweigh the small risk of HIV transmission.^ieng

Evaluation of Abbott Testpack Chlamydia for detection of Chlamydia trachomatis in patients attending sexually transmitted diseases clinics.

This work compares a rapid solid-phase EIA (Abbott TestPack Chlamydia) to tissue culture and a direct fluorescent antibody test (Syva Microtrak) for detection of C. trachomatis in 436 patients attending two inner-city sexually transmitted diseases (STD) clinics. The prevalence of C. trachomatis by culture was 12% (5% in men, 15% in women). Overall sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of TestPack compared to culture were 70%, 98%, 80%, and 96% respectively. In men, 12 specimens were positive by TestPack, while only eight specimens were positive by culture. Six TestPack-positive, culture-negative specimens were further evaluated by centrifugation of culture transport media and examination of the sediment for chlamydia elementary bodies (EBs) using fluorescent monoclonal antibodies to C. trachomatis. Using this procedure, five of six culture negative specimens contained EBs (revised sensitivity 85%, specificity 99%, PPV 92%, NPV 99%). In 285 women evaluable in culture and TestPack, 44 (15%) specimens were culture positive; TestPack was positive in 29 (sensitivity 66%) culture positive women. Of 241 culture negative patients, 238 had negative TestPack results (specificity 99%) and no EBs were detected in the culture-negative, TestPack-positive specimens. Twenty-three (8%) Microtrak specimens were unsatisfactory for testing; two of these were culture and TestPack positive. Therefore, of 263 specimens evaluable using Microtrak, 42 (16%) specimens were culture positive; Microtrak was positive in 32 (sensitivity 76%) culture-positive women. Abbott TestPack Chlamydia is a rapid (25 minute), visually read format requiring no specialized equipment for detection of chalmydia infections with a sensitivity comparable to that of Microtrak.

Behavioral contributions to acquisition of gonorrhea in patients attending an inner city sexually transmitted disease clinic.

To begin to define the behaviors that influence gonorrhea acquisition, a case-series of patients attending a sexually transmitted disease clinic was surveyed. Although gonorrhea rates were similar, men and women differed in sexual behaviors predictive of infection. Men with a new or casual partner were more likely to have gonorrhea than men with no such partners (adjusted odds ratio = 2.7); this finding did not hold true for women. Condom use in the previous month reduced the chances of gonorrhea acquisition for both men and women. More than 33% continued to engage in sexual activity after onset of symptoms or knowledge of sexually transmitted disease exposure. Individuals with repeated episodes of gonorrhea exhibited an array of risk-taking behaviors, such as intravenous drug use and casual sex partners. These data suggest the complex nature of the behaviors and sexual contexts within which gonorrhea acquisition occurs.

Comparison of GC-Lect and modified Thayer-Martin media for isolation of Neisseria gonorrhoeae.

A new selective medium, GC-Lect, was compared with modified Thayer-Martin medium (MTM) for isolation of Neisseria gonorrhoeae. Cultures from 620 sexually transmitted disease clinic patients were directly inoculated onto both media, placed in candle extinction jars, and incubated. N. gonorrhoeae was isolated from 175 (29%) of 607 genital cultures, 3 (3%) of 88 pharyngeal cultures, and 6 (29%) of 21 rectal cultures. Ten cultures were positive only on GC-Lect, and 3 were positive only on MTM. In 3 of the 10 cultures positive only on GC-Lect, overgrowth of a Capnocytophaga sp. may have obscured growth on MTM. In this study, vancomycin-susceptible (MIC, less than 4.0 micrograms/ml) N. gonorrhoeae was isolated on both media, and none of the isolates missed by either medium were susceptible to vancomycin. No differences were noted between the two media in time required for isolation of N. gonorrhoeae. While isolation rates of N. gonorrhoeae were similar, suppression of nongonococcal bacterial species by GC-Lect was superior to that by MTM. GC-Lect is equal to MTM for detection of N. gonorrhoeae and is superior for suppression of normal flora.