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Biomedical subjects

K H Mayer

Publications and source records attributed to K H Mayer.

At least 55 records · Page 3Linked to original sources

A national HIV community cohort: design, baseline, and follow-up of the AmFAR Observational Database. American Foundation for AIDS Research Community-Based Clinical Trials Network.

This article describes the design, methodology, baseline distributions, and general follow-up characteristics of the American Foundation for AIDS Research (AmFAR) National Observational Database (ODB) Project including the benefits and limitations of collecting information on a large simple cohort in the HIV community setting. The study prospectively followed 15,611 HIV-positive men and women and collected longitudinal and cross-sectional data on demographics, medical conditions, drug therapies, laboratory parameters, and survival. Participants were followed between October 1990 and December 1993 by 252 community-based sites coordinated by 22 centers in the Community-Based Clinical Trials Network (CBCT Network) throughout the United States (including Puerto Rico) and Toronto, Canada. The ODB provided quantitative information on a national level needed to track the HIV epidemic and plan clinical trials conducted through the Network, and to provide sites with local databases to monitor patients and facilitate access to therapies in clinical trials. Overall, the ODB contains information on 1,925 women (12%) and 13,686 men (88%), 60% white, 20% African American, 17% Latino/Hispanic, with 56,254 baseline and follow-up forms, a median follow-up of about 12 months, a 16% loss-to-follow-up, and an 11% mortality rate. AmFAR plans to place the ODB in the public domain.

Adolescent↗

HIV/AIDS patients' perspectives on adhering to regimens containing protease inhibitors.

OBJECTIVE: To gather qualitative data regarding HIV/AIDS patients' perspectives about HIV-1 protease inhibitors (PIs), and about their experiences taking and adhering to regimens containing PIs. DESIGN: Six focus groups of persons under care for HIV were conducted between September and November 1996 regarding participants' knowledge, awareness, experiences when taking, and adherence to antiretroviral regimens containing PIs. An identical discussion guide was used to facilitate all six groups. Focus group proceedings were audiotaped, transcribed, coded for themes, and analyzed qualitatively. SETTING: HIV/AIDS practices of three teaching hospitals and two community health centers. PATIENTS/PARTICIPANTS: Fifty-six patients with HIV disease: 28 men and 28 women. MEASUREMENTS AND MAIN RESULTS: Knowledge and positive impressions of PIs were prevalent among this diverse group of persons with HIV, and did not differ by race/ethnicity or gender. Most knew that these were new, potent medications for treating HIV/AIDS. Networks of persons with HIV and medical providers were the most important information sources. Those taking PIs were aware that adherence to the regimen is important, and most were using special strategies to maximize their own adherence, but expressed considerable frustration about the central role these medication regimens had assumed in their life. A subset who did not believe they would adhere to these regimens had declined treatment with them. Motivating factors for taking and adhering to these complex regimens were improving CD4 counts and viral loads and the patient-provider relationship. CONCLUSIONS: Among those with HIV/AIDS, awareness of PIs and their effectiveness is substantial, owing to the impact of informal networks and medical providers. This early positive "reputation" of PIs may enhance motivation for adherence. Those who are taking PIs invest substantial effort adhering to these complex regimens, but resent the need to make medications the focus of their lives.

Adult↗

Co-infection with Mycobacterium tuberculosis and HIV in high risk clinical care setting in Rhode Island.

We assessed the extent to which co-infection with HIV and Mycobacterium tuberculosis (Mtb) was diagnosed at several high risk clinical care sites from 1992 to 1994 to determine whether surveillance for co-infection was performed. Information on PPD skin testing, HIV status, and HIV risk exposures was extracted from records at HIV clinics in Rhode Island and a large database (HIV sites) and from records at the state TB clinic and the Rhode Island Health Department (TB sites). At the HIV sites, 34 of 1,408 HIV infected subjects were newly diagnosed with Mtb infection in the study period. At the TB sites, 16 of 1,389 subjects with newly diagnosed Mtb infection or disease were identified as HIV infected. Eighty per cent of the records reviewed for this study were incomplete. Hispanic subjects were at higher risk of being identified as co-infected at the HIV sites. At the TB sites, US-born subjects were at higher risk of being identified as co-infected Recommendations for high risk individuals include yearly tuberculosis skin testing. Adherence to these guidelines in selected high-risk clinical care sites in Rhode Island was substandard during the study period; the importance of Mtb screening was demonstrated in this study. Identification of groups that are at higher risk of having HIV and Mtb co-infection identified may enable health care providers to improve testing and prevention of tuberculosis at high risk clinical care settings.

AIDS-Related Opportunistic Infections↗

Mucosal candidal colonization and candidiasis in women with or at risk for human immunodeficiency virus infection. HIV Epidemiology Research Study (HERS) Group.

The epidemiology of mucosal candidal colonization and candidiasis was studied in a multicenter cohort of 871 human immunodeficiency virus (HIV)-seropositive and 439 demographically and behaviorally similar HIV-seronegative women. Cross-sectional analyses at baseline revealed that oropharyngeal colonization with Candida species was more prevalent among seropositive women and among women reporting recent cigarette smoking and injection drug use. Oropharyngeal candidiasis was also more prevalent among seropositive women. Both oropharyngeal colonization and candidiasis were significantly associated with a lower median CD4 lymphocyte count among seropositive women. Vaginal candidal colonization was more prevalent among seropositive women and among those reporting recent injection drug use and current insulin or oral antihyperglycemic therapy. Vaginal candidiasis was equally likely to be diagnosed in seropositive and seronegative women and was not significantly related to recent sexual contact. Neither vaginal colonization nor candidiasis was significantly related to a lower median CD4 lymphocyte count among seropositive women. Baseline evaluation indicated differences in the epidemiology of oropharyngeal and vaginal candidal colonization and candidiasis in HIV-seropositive women and suggested possible variation in pathogenesis of candidal infection at these two mucosal sites.

AIDS-Related Opportunistic Infections↗

Quantitation of HIV-1-specific IgG, IgA, and IgM antibodies in human genital tract secretions.

A quantitative enzyme-linked immunosorbent assay (ELISA) has been developed for the quantitation of HIV-1-specific immunoglobulins of the IgG, IgA, and IgM isotypes and was used to assess HIV-specific antibody concentrations in semen and cervicovaginal lavage (CVL) specimens. Immunoglobulin isotype concentrations were assessed by capture ELISA using immunoglobulin isotype-specific secondary antibodies and commercial IgG, IgA, and IgM standards. HIV-1 antibody detection kits (Abbott Laboratories, North Chicago, IL, U.S.A.) and immunoglobulin isotype-specific secondary antibodies were used to obtain optical density (OD) units for HIV-1-specific antibodies of each isotype. To determine the antibody concentrations from the OD values, ODs were compared with those from HIV-1-specific antibody isotype standards of known concentration obtained from CVL specimens of seropositive women by affinity binding to HIV antigen-coated beads and acid elution. The sensitivity of the HIV-1-specific immunoglobulin assay was 0.01 microg/ml for IgG, 0.04 microg/ml for IgA, and 0.08 microg/ml for IgM. The interassay coefficient of variation for the different immunoglobulin isotypes varied from 5% to 33%, being lowest for IgG and highest for IgM. HIV-1-specific antibodies were detected in all semen samples from seropositive men in concentrations ranging from 53 to 261 microg/ml. Thirteen of 14 samples contained high levels of HIV-1-specific IgG antibodies (22-72 microg/ml) whereas 10 of the 14 (71%) semen samples contained detectable but lower levels of HIV-1-specific IgA and IgM (maximum level: 3.7 microg/ml for IgA and 14.8 microg/ml for IgM). HIV-1-specific IgG antibodies were detected in all 196 CVL samples from seropositive women in concentrations ranging from 0.01 to 47 microg/ml, whereas only 16 women (8%) had IgA levels above the detectable limit (range, 1.4-3.9 microg/ml), and only eight women (4%) had IgM levels above the detectable limit (range, 1.8-8.6 microg/ml). None of 80 low-risk women or 20 low-risk men (negative controls) had detectable levels of HIV-1-specific antibodies in genital tract specimens. HIV-1-specific IgG levels in CVL specimens of seropositive women were significantly higher in individuals who had acquired HIV through heterosexual transmission, and a majority of women with elevated levels of HIV-specific IgA isotype antibodies in CVL samples had evidence of genital tract inflammation (>10[4] polymorphonuclear leukocytes [PMNs]/ml). Use of this quantitative method will facilitate direct comparison of data obtained within and among laboratories and enable further research on factors affecting antibody levels in genital tract secretions and their effects on HIV-1 transmission.

Enzyme-Linked Immunosorbent Assay↗

Use of the MQoL-HIV with asymptomatic HIV-positive patients.

The purpose of this study was to determine the appropriateness of the recently developed Multidimensional Quality of Life Questionnaire for HIV/AIDS (MQoL-HIV) as a measure of quality of life (QoL) in cases of asymptomatic human immunodeficiency virus (HIV) infection. The MQoL-HIV is a 40-item instrument measuring ten domains (mental health, physical health, physical functioning, social functioning, social support, cognitive functioning, financial status, partner intimacy, sexual functioning and medical care) relevant to HIV infection. An overall QoL score, the MQoL-HIV Index, is a weighted composite of two domain scores. In a sample of 216 HIV-infected men and women, the MQoL-HIV distinguished acquired immune deficiency syndrome (AIDS), symptomatic and asymptomatic cases in overall QoL and in seven individual QoL domains. The index was responsive to perceived QoL changes over 5.5 months (r = 0.52). We also found the MQoL-HIV was less susceptible to ceiling effects in asymptomatic cases than was the Medical Outcomes Study (MOS) SF-20. These results suggest that the MQoL-HIV is a valid and reliable measure of QoL for both asymptomatic and symptomatic HIV infection.

Adult↗

Childhood sexual abuse among homosexual men. Prevalence and association with unsafe sex.

Of 327 homosexual and bisexual men participating in an ongoing cohort study pertaining to risk factors for HIV infection who completed a survey regarding history of sexual abuse, 116 (35.5%) reported being sexually abused as children. Those abused were more likely to have more lifetime male partners, to report more childhood stress, to have lied in the past in order to have sex, and to have had unprotected receptive anal intercourse in the past 6 months (odds ratio 2.13; 95% confidence interval 1.15-3.95). Sexual abuse remained a significant predictor of unprotected receptive anal intercourse in a logistic model adjusting for potential confounding variables.

Adolescent↗

Factors associated with increased levels of human immunodeficiency virus type 1 DNA in semen.

Human immunodeficiency virus type 1 (HIV-1)-infected cells have been isolated from semen and may be a major source of transmissible virus. Quantitative polymerase chain reaction (PCR) assay was used to determine HIV proviral DNA load in cellular fractions of semen from 74 antiviral therapy-naive HIV-1-seropositive men and 53 paired blood samples. HIV-1 DNA was detected in 65% of semen (range: <10-5000 copies/mL) and 100% of blood samples (range: 20-2500 copies/mL). HIV-1 DNA copy numbers in semen correlated significantly with those in blood, but for most cases, the concentration of blood HIV-1 DNA was higher (mean blood-to-semen ratio = 2.9). Factors associated with elevated HIV-1 provirus levels in semen included reduced peripheral CD4 cell count and asymptomatic genital tract inflammation (>10(6) white blood cells/mL of semen). These data provide evidence that genital tract inflammation and reduced peripheral CD4 cell count may be associated with enhanced sexual transmission of HIV-1 because of increased numbers of HIV-1-infected cells in semen.

CD4 Lymphocyte Count↗

T lymphocytes and macrophages, but not motile spermatozoa, are a significant source of human immunodeficiency virus in semen.

The cellular fraction of semen contains spermatozoa, immature germ cells, leukocytes, and epithelial cells. Recent evidence implicates seminal cells as a major source of sexually transmitted human immunodeficiency virus (HIV) in semen, but the identity and infectious potential of infected cells remains poorly understood. HIV provirus was found in 75% of viable semen cell samples by polymerase chain reaction and in 88% of paired blood cell samples from HIV-seropositive men. When semen cell subpopulations were isolated by an immunomagnetic bead technique, T cells were found to be most commonly HIV-infected (75% of samples), followed by macrophages (38% of samples). Viral DNA was never detected in motile spermatozoa or immature germ cell populations. Semen leukocytes proliferated in response to mitogenic and antigenic challenge and produced p24 following stimulation with irradiated allogeneic cells. These data provide evidence that both T cells and macrophages, but not germ cells, are cellular vectors of HIV transmission in semen.

Cell Division↗

Interest among gay/bisexual men in greater Boston in participating in clinical trials of preventive HIV vaccines.

To estimate interest in HIV preventive vaccine trials, we administered questionnaires to two otherwise demographically similar cohorts of older (mean 40 years) and younger (mean 23 years) gay men in Boston. Questionnaire responses were linked to concurrent behavioral and demographic data. Univariate analyses, performed separately for older and younger cohorts, identified factors that distinguished participants who were "very interested" from those who were "not at all interested". Multivariate logistic regression analyses were used to adjust for confounding. Among all 630 participants, 215 (34%) were "not at all" interested in participating, 306 (49%) were "somewhat" interested, and 102 (16%) were "very" interested. Older men were significantly more likely than younger men to be "very" interested and less likely to be "not at all interested." Among both older and younger men, perceived peer willingness to enroll in vaccine trials predicted interest after adjusting for confounding. Among older men, optimism about success in vaccine development also predicted interest. In the younger cohort, men recruited in community settings (e.g., bars, nightclubs) were more interested in vaccine trial participation than were those recruited by outreach workers and word of mouth on college campuses. Vaccine-induced seroconversion evoked significant concern.

AIDS Vaccines↗

Pattern of gp120 sequence divergence linked to a lack of clinical progression in human immunodeficiency virus type 1 infection.

Differential rates of AIDS development and/or T4 lymphocyte depletion in HIV-1-infected individuals remain unexplained. The hypothesis that qualitative differences in selection pressure in vivo may account for different rates of disease progression was addressed in nine eligible study participants from a cohort of 315 homosexual men who have been followed since 1985. Disproportionately fewer changes in variable regions and more in C3 of gp12O were found to be significantly associated with slower disease progression. Our finding provides the first example to demonstrate that differential selection pressure related to the emergence of HIV-1 variants is associated with long term nonprogression. Candidate vaccines that elicit strong selection pressure on C3 of gp120 are likely to provide better protection than those targeting variable regions.

Base Sequence↗

Laboratory evaluation of acute upper genital tract infection.

OBJECTIVE: To evaluate the diagnostic test characteristics of common tests used to diagnose upper genital tract infection. METHODS: Subjects included women who either met the Centers for Disease Control and Prevention's minimal criteria for acute pelvic inflammatory disease or who had other signs of upper genital tract infection (i.e., atypical pelvic pain, abnormal uterine bleeding, or cervicitis). The subjects were evaluated with a baseline interview, comprehensive laboratory testing, and either an endometrial biopsy or laparoscopy for definitive diagnosis of upper genital tract infection. Patients were considered positive for upper genital tract infection if they had any of the following findings: 1) histologic evidence of acute endometriosis or salpingitis, 2) laparoscopic visualization of purulent exudate in the pelvis without another source, or 3) positive testing for Neisseria gonorrhoeae or Chlamydia trachomatis from the endometrium, fallopian tubes, or pelvis. RESULTS: One hundred twenty women with adequate endometrial samples were evaluated between August 1993 and September 1995. The median age of the study population was 24 years: 38% were white, 52% were smokers, 81% were insured by Medicaid or were uninsured, and 67% were single. Sensitivities for elevated white blood cell count (WBC), erythrocyte sedimentation rate, C-reactive protein, and increased vaginal white blood cells are 57, 70, 71, and 78%, respectively. If any one test is abnormal, the sensitivity is 100% and specificity is 18%. If all four tests are abnormal, sensitivity is 29% and specificity is 95%. CONCLUSION: Testing for increased vaginal white blood cells was found to be the most sensitive laboratory indicator for upper genital tract infection, whereas serum WBC was the most specific. No one diagnostic laboratory test is pathognomonic for upper genital tract infection. Combinations of positive tests can improve diagnostic specificity and positive predictive value, but with a diminution of sensitivity and negative predictive value. Combinations of negative tests can reliably exclude upper genital tract infection.

Acute Disease↗

Human immunodeficiency virus infection and acquired immunodeficiency syndrome among North American women.

Women constitute the fastest growing segment of adults with acquired immunodeficiency syndrome (AIDS), representing 18% of all cases in the United States in 1994. Heterosexual transmission is now the dominant route by which women are infected. Recent reports indicate that although certain manifestations may be different in women than in men, the rate of clinical progression is similar when they receive comparable medical treatment. Antiretroviral therapy is equally as effective in women as in men. As in men, Pneumocystis carinii pneumonia is the most frequent AIDS-defining diagnosis in women. Candida esophagitis and ulcers secondary to herpes simplex virus are more common in women. Kaposi's sarcoma is rare. The prevalence of humanpapilloma virus infection and cervical neoplasia is increased in HIV-seropositive women. Vaginitis due to candida, trichomonas, and bacterial vaginosis are common findings among human immunodeficiency virus seropositive women. The clinical course and response to therapy in certain sexually transmitted diseases (syphilis and herpes) may be altered. The use of zidovudine during pregnancy and delivery has been associated with a 67.5% reduction in vertical transmission.

Acquired Immunodeficiency Syndrome↗