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Biomedical subjects

Curtis L Meinert

Publications and source records attributed to Curtis L Meinert.

At least 19 recordsLinked to original sources
PubMed2007

Longitudinal study of the ocular complications of AIDS: 2. Ocular examination results at enrollment.

OBJECTIVE: To report the clinical features on eye examination of patients with AIDS in the era of highly active antiretroviral therapy (HAART). DESIGN: Cohort study. PARTICIPANTS: Patients with AIDS, age > or = 13 years. METHODS: Ophthalmologic examination, contrast sensitivity, visual fields, and laboratory testing at enrollment. MAIN OUTCOME MEASURES: Eye examination findings at enrollment. RESULTS: As of March 31, 2003, 1632 participants with AIDS were enrolled. Evidence of intraocular inflammation was substantially more common among patients with cytomegalovirus (CMV) retinitis or other major ocular complications than among those without, as were the complications of infection and inflammation, including cataracts, pseudophakia, macular edema, and epiretinal membrane. Among patients with CMV retinitis, macular edema and epiretinal membrane formation were most common among patients with long-standing retinitis and immune recovery. Patients with newly diagnosed retinitis had eye examination findings similar to those reported in the pre-HAART era. Visual impairment (<20/40) in the better-seeing eye was present in 9.2% of patients with CMV retinitis, 41.4% of patients with other major ocular complications (primarily ocular opportunistic infections), and only 0.6% of patients with no major ocular complication (P<.0001). Although patients without major ocular complications generally had good visual acuity, approximately 9.8% of eyes and 6.6% of participants had contrast sensitivity loss sufficient to impair reading speed. CONCLUSIONS: In the HAART era, CMV retinitis and other ocular opportunistic infections are associated with intraocular inflammation, structural ocular complications, and visual impairment. Patients with newly diagnosed CMV retinitis have eye examination findings similar to those seen in the pre-HAART era.

AIDS-Related Opportunistic Infections↗
PubMed2006

Effect of cytomegalovirus retinitis on the risk of visual acuity loss among patients with AIDS.

PURPOSE: To describe the prevalence and incidence of reduced visual acuity in eyes of patients with AIDS and without cytomegalovirus (CMV) retinitis at enrollment and estimate the proportion of incident vision loss attributable to new-onset CMV retinitis in this cohort. DESIGN: Multicenter prospective observational study. PARTICIPANTS: Three thousand fourteen eyes of 1507 patients with AIDS and without CMV retinitis at enrollment. METHODS: Medical history, ophthalmologic examination, and laboratory testing collected at enrollment and at follow-up visits every 6 months thereafter. MAIN OUTCOME MEASURES: Loss of visual acuity across the < or =20/50 and < or =20/200 thresholds and doubling of the visual angle; potential causes of this vision loss. RESULTS: For eyes of patients without CMV retinitis at enrollment, the proportions with best-corrected visual acuity of < or =20/50 and of < or =20/200 were 3.9% and 1.8%, respectively. The incidence rates of vision loss to < or =20/50, < or =20/200, and to a doubling of the visual angle were 1.5/100 eye-year (EY), 0.8/100 EY, and 2.1/100 EY, respectively. Approximately 40% of the incident vision loss was attributable to CMV retinitis diagnosed during the follow-up period, and approximately 25% was attributable to cataract. CONCLUSIONS: Although the development of CMV retinitis was the most common reason for visual acuity loss in eyes of our patients with AIDS, it accounted for less than half of the vision loss in our population (approximately 40%). Newly diagnosed cataract during the follow-up period accounted for a substantial amount of incident vision loss as well.

Acquired Immunodeficiency Syndrome↗
PubMed2006

Presentation in relation to publication of results from clinical trials.

BACKGROUND: Results from clinical trials are typically disseminated first by presentation at scientific meetings. An important question has to do with the role of presentation in improving the quality of manuscripts submitted to the journals as well as the effect of presentation in speeding, or delaying subsequent publication. The aim of this research is focused on presentation practices of trialists to examine their effect on the timing of publications of clinical trial results. METHODS: Six hundred and one (601) trials published in 1996 and 1997 were identified via MEDLINE using medical subject heading "clinical trials" or the occurrence of the term in the text and by limiting to publication type "clinical trial". Authors of those trials were surveyed to determine prior presentation history for the identified trials. RESULTS: Among the 601 trials identified, complete responses to questionnaires were obtained for 379 (63%) trials. The median time from completion to first submission of the primary results manuscript was 11 months and the median time from completion to publication was 25 months for the 220 trials involving presentation prior to submission for publication. The corresponding median times from completion to first submission and publication for the subset of trials not involving presentation prior to the submission were 8 and 19 months (159 trials), respectively. The adjusted relative hazard for publication for trials involving presentation prior to first submission was 0.55 versus trials not involving presentation prior to first submission (95% confidence interval, 0.44 to 0.69). CONCLUSION: Despite the importance of dissemination of results prior to publication, investigators should carefully weigh a potential gain in quality against a potential for delay in submission of the primary results manuscript by presentation at scientific meetings. The findings of our study suggest that presentation prior to submission may increase time to publication. Inclusion of presentation dates in clinical trial registers should be considered to allow future studies investigating presentation and publication practices.

Clinical Trials as Topic↗
PubMed2006

Causes of visual acuity loss among patients with AIDS and cytomegalovirus retinitis in the era of highly active antiretroviral therapy.

PURPOSE: To quantitate the frequencies of the common causes of visual acuity loss for patients with AIDS and cytomegalovirus (CMV) retinitis in the era of highly active antiretroviral therapy (HAART). DESIGN: Multicenter prospective observational study. PARTICIPANTS: Three hundred seventy-nine patients (494 eyes) with CMV retinitis. METHODS: Follow-up every 3 months with medical history, ophthalmologic examination, and laboratory testing. MAIN OUTCOME MEASURES: Loss of visual acuity across the 20/50 or worse and 20/200 or worse thresholds and doubling of the visual angle; frequencies of causes of such vision loss. RESULTS: Overall, involvement of the posterior pole with CMV retinitis (zone 1 retinitis) accounted for approximately one half of incident visual acuity loss of 20/50 or worse, 20/200 or worse, and of doubling of the visual angle. Cataract and retinitis-related retinal detachment were the second and third most common causes of vision loss, accounting for 22% to 33% and 13% to 20% of vision loss for the 3 outcomes, respectively. In subset analysis, cataract and cystoid macular edema (CME) accounted for approximately 50% of incident vision loss in eyes of patients with longstanding CMV retinitis and immune recovery at baseline, but these complications accounted for <10% of incident vision loss in eyes of patients with newly diagnosed CMV retinitis at baseline. Of eyes that had a vision-threatening complication of CMV retinitis, eyes that developed retinal detachment had the highest risk of vision loss, with 100% of eyes developing visual impairment (20/50 or worse vision) and 42% of eyes developing legal blindness (20/200 or worse vision) at 12 months after diagnosis of the retinal detachment. CONCLUSIONS: In the HAART era, zone 1 involvement and retinal detachment remain the most common causes of visual acuity loss among patients with CMV retinitis. Cataract and CME also are common causes of loss of visual acuity, primarily in those patients with HAART-induced immune recovery.

Acquired Immunodeficiency Syndrome↗
PubMed2006

Incidence of and risk factors for visual acuity loss among patients with AIDS and cytomegalovirus retinitis in the era of highly active antiretroviral therapy.

PURPOSE: To describe the incidence of and risk factors for visual acuity loss among patients with AIDS and cytomegalovirus (CMV) retinitis in the era of highly active antiretroviral therapy (HAART). DESIGN: Multicenter prospective observational study. PARTICIPANTS: Three hundred seventy-nine patients with AIDS and CMV retinitis (494 eyes). METHODS: Follow-up every 3 months with medical history, ophthalmologic examination, and laboratory testing. MAIN OUTCOME MEASURES: Incidence of visual acuity loss to 20/50 or worse, to 20/200 or worse, and of doubling of the visual angle in eyes affected with CMV retinitis. RESULTS: Among the 494 eyes with CMV retinitis, the baseline frequencies of visual acuity loss to 20/50 or worse and to 20/200 or worse were 29% and 15%, respectively. Over a median follow-up period of 3.1 years, the incidences of visual acuity loss to 20/50 or worse, to 20/200 or worse, and of doubling of the visual angle were 0.10/eye-year (EY), 0.06/EY, and 0.13/EY, respectively. Immune recovery was associated with a 42% reduction in vision loss to 20/50 or worse and with a 61% reduction in vision loss to 20/200 or worse after adjusting for confounding. Of the patients with immune recovery at baseline, 17% had immune recovery uveitis (IRU). In these patients, the incidence rate of 20/50 or worse vision was similar to that observed in patients without immune recovery (0.17/EY vs. 0.16/EY), but the incidence of 20/200 or worse vision was similar to that observed among patients with immune recovery (0.04/EY vs. 0.04/EY). CONCLUSIONS: Cytomegalovirus retinitis is associated with a substantial risk of incident vision loss in the era of HAART. Those who have HAART-induced immune recovery have approximately 50% lower risk of visual acuity loss. Presence of IRU at baseline attenuated the protective effect of immune recovery for moderate vision loss but not for blindness.

Acquired Immunodeficiency Syndrome↗
PubMed2006

Single-dose azithromycin prevents trichiasis recurrence following surgery: randomized trial in Ethiopia.

BACKGROUND: Trichiasis recurrence following surgery is a serious problem for trachoma programs. OBJECTIVE: To determine if postoperative treatment with azithromycin compared with topical tetracycline reduces recurrence up to 1 year, and if azithromycin treatment of household members provides additional benefit compared with treating only the surgical patient. DESIGN: A randomized, single-masked, clinical trial was conducted in Ethiopia. A total of 1452 patients with trichiasis were randomized 1:1:1 to the following 3 arms: single-dose (1 g) oral azithromycin alone, single-dose azithromycin for household members (20 mg/kg up to 1 g) plus the patient, or topical tetracycline (twice per day for 6 weeks). MAIN OUTCOME MEASURES: Trichiasis recurrence within 1 year following surgery. RESULTS: The combined azithromycin groups had significantly fewer recurrences, 6.9 of 100 person-years overall, compared with topical tetracycline, 10.3 of 100 person-years (P = .047). There was no additional reduction in the arm that also treated household members, 8.1 of 100 person-years, compared with treating the surgical patients alone, 5.8 of 100 person-years (P = .19). CONCLUSIONS: In trachoma-endemic areas, a single dose of azithromycin reduced postoperative trichiasis recurrence rates by one third compared with topical tetracycline. Application to Clinical Practice In countries where azithromycin is part of the Trachoma Control Program, patients with trachomatous trichiasis should be treated postoperatively to prevent recurrence.

Administration, Oral↗
PubMed2006

Design of Depression in Alzheimer's Disease Study-2.

OBJECTIVE: Research on the efficacy of antidepressant therapy for depressive symptoms in Alzheimer disease has been hampered by lack of systematic diagnosis, small sample sizes, and short-term follow up. To address these issues, the authors present the design of the Depression in Alzheimer's Disease Study-2 (DIADS-2), a randomized, placebo-controlled multicenter trial to evaluate the efficacy and safety of the selective serotonin reuptake inhibitor sertraline for the treatment of depression in people with Alzheimer disease. METHODS: The authors present and discuss the following important aspects of the design: the inclusion of structured psychosocial therapy for the caregivers of all participants; the measurement not only of patient mood outcomes, but also of global and functional outcomes for patients and mood and burden outcomes for caregivers; the ongoing rating of multiple diagnostic criteria to allow nosologic study of depression in Alzheimer disease; the evaluation of both short-term efficacy and longer-term outcomes; the follow up of all patients regardless of whether they complete study treatment; and the unmasking of treatment assignment at the conclusion of each patient's treatment phase. CONCLUSIONS: The authors believe these design elements are important features to be included in trials of depression and other neuropsychiatric disturbances in Alzheimer disease.

Affect↗
PubMed2005

Effect of zinc and vitamin A supplementation on antibody responses to a pneumococcal conjugate vaccine in HIV-positive injection drug users: a randomized trial.

HIV-infected individuals have impaired immune responses to vaccines and high rates of pneumococcal disease. The effect of vitamin A and zinc supplementation on the immunogenicity of a 7-valent pneumococcal CRM-197 conjugate vaccine (PC-7) was evaluated in 118 HIV+ injection drug users. Subjects were randomized to oral 400,000 IU vitamin A, 300 mg zinc, vitamin A + zinc, or placebo, then immunized. Geometric mean titer increased 1.3-3.3-fold for all pneumococcal serotypes. PC-7 elicited an immune response in HIV-infected adults but neither vitamin A nor zinc altered the immunogenicity of the evaluated vaccines.

Adult↗
PubMed2005

Clinical application of operationalized criteria for 'Depression of Alzheimer's Disease'.

OBJECTIVES: 'Depression of Alzheimer's Disease' (dAD) is a common complication of Alzheimer's disease and is increasingly recognized as a syndrome with a clinical presentation differing from major depression. Criteria for the diagnosis of dAD have been proposed previously. METHODS: This paper presents these criteria in operationalized format designed to be accessible for clinical use. Four cases are discussed that demonstrate the use of these criteria and illustrate important differences between dAD and major depression. RESULTS: The dAD criteria are broader than DSM-IV criteria for Major Depressive Episode and incorporate caregiver input. CONCLUSIONS: Given the differences between dAD and major depression diagnoses, it is important to assess the efficacy of treatments for dAD. Depression in Alzheimer's Disease-2 (DIADS-2) is a controlled trial of dAD treatments that will also assess the validity of these criteria.

Aged↗
PubMed2004

Relative contributions of reduced vision and general health to NEI-VFQ scores in patients with neovascular age-related macular degeneration.

OBJECTIVE: To estimate the relative contributions of central vision loss and general health to vision-targeted quality of life as measured by the National Eye Institute Visual Function Questionnaire (NEI-VFQ). METHODS: Data on quality of life (NEI-VFQ and the 36-Item Short-Form Health Survey [SF-36]) and visual acuity were collected as part of the Submacular Surgery Trials Pilot Study. Information on medical conditions was collected by patient chart review. Twenty-four-month data for 120 patients were analyzed using linear regression methods. RESULTS: Median patient age at the 24-month examination was 77 years; 60% were women, and 98% were non-Hispanic whites. A 3-line decrement in visual acuity in the better-seeing eye was associated with a 5.1- to 17.1-point decrement in NEI-VFQ scores after adjustment for general health (SF-36 physical component summary [PCS] and mental component summary [MCS] scores). A 10-point decrement in the PCS score was associated with a 4- to 9-point decrement in NEI-VFQ scores after adjustment for visual acuity in the better-seeing eye and MCS score. A 10-point decrement in the MCS score was associated with a 4- to 8-point decrement in NEI-VFQ scores after adjustment for visual acuity in the better-seeing eye and PCS score. Diabetes, arthritis/rheumatism, and hypertension also had large effects on NEI-VFQ scores in the adjusted analysis. CONCLUSIONS: The NEI-VFQ is sensitive to differences in visual acuity in the better-seeing eye, as expected, and to differences in general health. Adjustment for general health should be considered when comparing NEI-VFQ scores between patient groups.

Aged↗
PubMed2004

Is adjustment of National Eye Institute Visual Function Questionnaire scores for general health necessary in randomized trials?

PURPOSE: To assess whether treatment comparison of National Eye Institute Visual Function Questionnaire (NEI-VFQ) scores in a clinical trial is influenced by general health to warrant adjusting for it. DESIGN: Two randomized pilot trials. METHODS: Patients enrolled in two randomized pilot trials of submacular surgery versus observation for choroidal neovascularization had quality of life interviews (NEI-VFQ and the Short Form-36 Health Survey) 24 months after enrollment. Information on comorbidities was collected through chart reviews. Data from 120 patients were analyzed using linear regression methods. RESULTS: Adjustment for comorbidities did not change the magnitude of the treatment effect on NEI-VFQ scores. However, adjustment for Short Form-36 physical and mental component summaries produced changes in the estimated treatment effect when NEI-VFQ scores were compared. CONCLUSIONS: Adjustment of NEI-VFQ scores for general health may be advisable. The Short Form-36 summary scores may be appropriate for this purpose.

Aged↗
PubMed2004

Treatment effects monitoring committees and early stopping in large clinical trials.

BACKGROUND: Treatment effects monitoring is a process carried out over the course of a trial to determine whether it should continue unaltered. The purpose of monitoring is to protect persons enrolled from harm, caused either by exposure to an ineffective or harmful treatment or failure to provide a better treatment. The aim of this paper is to characterize treatment effects monitoring committees (TEMCs) as extant in published trials and to examine the effect of their presence on the premature stopping of a trial. METHODS: Trials published in 1990-1995 in the Annals of Internal Medicine, Archives of Internal Medicine, British Medical Journal, Journal of the American Medical Association, Lancet, New England Journal of Medicine or Controlled Clinical Trials were identified via MEDLINE (4279 publications). Abstracts were screened to include only trials with parallel treatment designs and sample sizes of > or = 200, reducing the set to 661 papers. Those papers were then read, reducing the set to 562 after exclusion of papers not reporting trial results. The results that follow come from a review of these 562 published papers and from the responses to two questionnaires. The first was mailed to the corresponding author, and the second to the chair of the monitoring body or other contact as provided by the author in response to the first questionnaire. RESULTS: Less than half (48%) of the 562 trials had TEMCs. Factors having a positive univariate relationship with the presence of a TEMC include National Institutes of Health (NIH) sponsorship, larger sample size, multicentered, longer data collection and follow-up, and mortality as an outcome. Most of the early stops occurred in trials with TEMCs (66 out of 78). The odds ratios for early stopping for trials with TEMCs versus those without TEMCs was 4.4 (CI: 2.3-8.5). CONCLUSIONS: The evidence suggests that early stopping is associated with the presence of a TEMC, but a substantial number of trial reports do not mention the presence of a TEMC even when one was used to stop a trial early.

Clinical Trials Data Monitoring Committees↗
PubMed2004

The UGDP controversy: thirty-four years of contentious ambiguity laid to rest.

The University Group Diabetes Program (UGDP), launched in 1960, was an early placebo-controlled, multi-center clinical trial devised to determine which, if any, of the treatments for type 2 diabetes was efficacious. Because of an excess of cardiac deaths in patients treated with tolbutamide, a sulfonylurea drug, investigators terminated this limb of the study. This decision was met with strong resistance from the parent drug company and many in the medical community. Subsequent clinical studies both supported and conflicted with the UDGP findings, so that the controversy has persisted. A rationale for sulfonylurea-induced cardiotoxicity emerged with the observation that these drugs block ischemic preconditioning, a protective maneuver that reduces myocardial damage after temporary blockage of coronary blood flow; this action of sulfonylureas provided laboratory support for the UGDP findings. The development of newer sulfonylurea drugs that do not block ischemic preconditioning has rendered the UGDP controversy moot and has preserved a place for sulfonylureas in the treatment of type 2 diabetes.

Cardiomyopathies↗
PubMed2003

Data and safety monitoring board deliberations resulting in the early termination of the Monoclonal Antibody Cytomegalovirus Retinitis Trial.

We report on two features of the early termination of the studies of ocular complications of AIDS monoclonal antibody cytomegalovirus retinitis trial: one related to the deliberative process of the treatment effects monitoring body (the policy and data monitoring board [PDMB]) and the other related to the relationships among the PDMB, the investigators, and the joint sponsors (the National Institutes of Health and a pharmaceutical company). The PDMB was challenged with reconciling internally inconsistent safety and mortality data and determining the weight to give mortality data from other concurrently running trials. The coordinating center faced a challenge in negotiating how to communicate results from a jointly sponsored trial. Early resolution of certain organizational and procedural issues, such as rules regarding absentee voting, to which body the monitoring committee should report officially, and the timing and general content of dissemination of different kinds of results, would make jointly sponsored trials more robust to difficulties at the final hour.

AIDS-Related Opportunistic Infections↗
PubMed2002

Influence of filgrastim (granulocyte colony-stimulating factor) on human immunodeficiency virus type 1 RNA in patients with cytomegalovirus retinitis.

Filgrastim, or granulocyte colony-stimulating factor, reverses neutropenia associated with human immunodeficiency virus type 1 (HIV-1) and cytomegalovirus (CMV) infections. During a trial of anti-CMV retinitis therapies coadministered with antiretroviral therapy, 2-4 plasma specimens of HIV-1 RNA were collected from 36 HIV-1-infected patients receiving filgrastim to prevent neutropenia and from 36 patients not receiving filgrastim. For both groups, the crude mean and mean rate of change of HIV-1 log(10) RNA levels were similar. Adjustment for covariates (CD4(+) T cell lymphocytes, virus load at enrollment, level of neutropenia and antiretroviral therapy [mainly non-highly active antiretroviral therapy], and anti-CMV therapy during follow-up) resulted in a mean log(10) HIV-1 RNA level for individuals receiving filgrastim versus those not receiving the drug of 5.11 versus 4.87 (P=.12) and respective log mean rates of change per month of -0.08 versus -0.21 (P=.08). This latter difference has borderline statistical significance, which suggests that filgrastim may reduce the decline of HIV-1 RNA loads.

AIDS-Related Opportunistic Infections↗
PubMed2002

Use of filgrastim as adjuvant therapy in patients with AIDS-related cytomegalovirus retinitis.

BACKGROUND: Neutropenia in AIDS predisposes to bacterial infection. Granulocyte colony-stimulating factor (filgrastim) can reverse neutropenia. OBJECTIVE: To determine the effects of filgrastim on bacterial infections, hospitalization, and mortality in patients with cytomegalovirus retinitis and AIDS. METHODS: Using a person-time analysis, a retrospective cohort study of filgrastim adjuvant therapy in three multicenter clinical trials of anti-cytomegalovirus therapy during the period 1990-1997 measured filgrastim use, bacterial infections, and mortality. RESULTS: Of 719 patients, 379 patients used filgrastim for 31% of the follow-up time. There was an inverse relationship between the 389 confirmed bacterial infections, including 186 bacteremias, and absolute neutrophil counts. Before adjustment for CD4 T-cells counts and antibiotic/antiretroviral therapy, filgrastim was associated with reduced risk of catheter-related bacteremia [relative risk (RR), 0.52; P = 0.02] and repeat bacterial infection (RR, 0.41; P = < 0.01). After adjustment, the RR of catheter-related bacteremia with filgrastim use was decreased (RRadj, 0.69; P = 0.16) and the RR of repeat bacterial infection with filgrastim use was of marginal significance (RRadj, 0.57; P = 0.07), possibly due to the confounding effect of trimethoprim-sulfamethoxazole on all bacteremia (RRadj, 0.55; P = < 0.01). Unrelated to bacteremia, filgrastim use was associated with a 56% reduction in mortality (P < 0.01). CONCLUSIONS: There was a large survival benefit associated with filgrastim use in this study but the reasons for this benefit are unclear. Although a reduction in crude risk of some bacterial infections with filgrastim use was detected, after adjustment for potentially confounding factors these risks were smaller and no longer statistically significant.

AIDS-Related Opportunistic Infections↗
PubMed2002

Double placebo design in a prevention trial for Alzheimer's disease.

The Alzheimer's Disease Anti-inflammatory Prevention Trial (ADAPT) is designed to compare two nonsteroidal anti-inflammatory agents against placebo. A placebo control for two active treatments can be achieved in several ways, each of which may have different implications for the logistics of drug supply, enrollment, adherence to treatment, and the validity of specific treatment comparisons. The authors outline the placebo designs considered in ADAPT, discuss their advantages and disadvantages, and provide their rationale for and the consequences of the selection of the double placebo design.

Aged↗