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Biomedical subjects

C E Stevens

Publications and source records attributed to C E Stevens.

At least 19 recordsLinked to original sources
PubMed1997

Willingness to participate in HIV-1 vaccine efficacy trials and the effect of media events among gay and bisexual men in New York City: Project ACHIEVE.

Efficacy trials of candidate HIV-1 vaccines require study populations at high risk of infection who adhere to study protocols and who are willing to participate. Data from HIV-1 antibody-negative men (n = 698) enrolled in Project ACHIEVE in New York City were analyzed to assess willingness to participate in efficacy trials, factors influencing willingness, and the effect on willingness of the June 1994 media events about the decision not to proceed with phase III trials and about breakthrough infections during phase I and II vaccine trials. Sixty-eight percent indicated they would definitely or probably be willing to participate. Men enrolled during the time of media events were significantly less willing compared with men enrolled during other periods. These men were also more likely to mention safety of the vaccine, fear or mistrust of research or government, and social risks as important factors in their decision compared with men enrolled during other periods. The most frequently cited motivator for participation was altruism (57%); the most frequently cited barriers were vaccine safety (36%) and vaccine-induced seropositivity (19%). A substantial proportion of this cohort was willing to participate in future vaccine efficacy trials. However, because willingness may be affected by issues of vaccine safety, vaccine-induced seropositivity, and media coverage of these issues, significant efforts are needed for participant and community education, and specific concerns must be addressed in the design and implementation of trials.

Adult↗
PubMed1997

Prevalence and correlates of antibody to chlamydial heat shock protein in women attending sexually transmitted disease clinics and women with confirmed pelvic inflammatory disease.

A cross-sectional study of 306 women was done to correlate antibody to the chlamydial hsp60 (Chsp60) with epidemiologic, serologic, and laparoscopic findings of women with and without pelvic inflammatory disease (PID). Of the 306 women, 150 had confirmed PID by laparoscopic (n = 69) or histologic (n = 81) criteria, and 156 sexually transmitted disease clinic attendees without clinical PID did (n = 94) or did not (n = 62) have chlamydia. In multivariate analyses, Chsp60 antibody was independently associated with confirmed PID, age > 20 years, nonwhite race, > 10 lifetime sex partners, current oral contraceptive use, and IgG antibody titers; it was not associated with a positive Chlamydia trachomatis culture. Among the 69 women with laparoscopic evidence of PID, the highest level of Chsp60 antibody (optical density > 1.0) was found in 8 (80%) of 10 women with occluded tubes, compared with 11 (19%) of 58 with patent tubes (P < .001). We conclude that antibody to Chsp60 was significantly correlated with risk factors for PID, confirmed PID, and occluded fallopian tubes but not with acute C. trachomatis infection without PID.

Acute Disease↗
PubMed1997

An ELISA for detection of antibodies to the E2 protein of GB virus C.

An ELISA was developed for detection of antibodies to GB virus C (GBV-C) using a recombinant E2 protein expressed in CHO cells. Seroconversion to anti-E2 positivity was noted among several persons infected with GBV-C RNA-positive blood through transfusion. Of 6 blood recipients infected by GBV-C RNA-positive donors, 4 (67%) became anti-E2 positive and cleared their viremia. Thus, anti-E2 seroconversion is associated with viral clearance. The prevalence of antibodies to E2 was relatively low (3.0%-8.1%) in volunteer blood donors but was higher in several other groups, including plasmapheresis donors (34.0%), intravenous drug users (85.2%), and West African subjects (13.3%), all of whom tested negative by GBV-C reverse-transcription polymerase chain reaction (RT-PCR). These data demonstrate that testing for anti-E2 should greatly extend the ability of RT-PCR to define the epidemiology and clinical significance of GBV-C.

Africa↗
PubMed1997

Safety of a nonoxynol-9 vaginal gel in Kenyan prostitutes. A randomized clinical trial.

OBJECTIVE: To evaluate the safety and toxicity of once-daily administration of Advantage-24 (Columbia Research Laboratories, Inc., Rockville Centre, NY), a vaginal gel containing 52.5 mg of nonoxynol-9 (N-9), including the effects of this gel on the vaginal and cervical epithelium. STUDY DESIGN: Randomized, placebo-controlled, double-blind crossover trial, with a 2-week product application period and a 2-week washout period. METHODS: Female sex workers in Mombasa, Kenya were randomized to one of two sequences, N-9 followed by placebo, or vice versa. Women were instructed to apply one applicator of N-9 or placebo gel vaginally once each day. During each of the two product periods, subjects were evaluated by questionnaire and physical examination, including colposcopy, after 7 and 14 days of product use. The primary outcome was genital epithelial disruption. RESULTS: Sixty subjects were randomized, of whom 52 (87%) had complete follow-up. There were four episodes of epithelial disruption, three of which occurred during the placebo period and one during the N-9 period. The estimated risk of epithelial disruption associated with N-9 use was 0.33 (95% confidence interval, 0.03-3.26). There was no increased frequency of other, nondisruptive epithelial lesions during N-9 use. CONCLUSIONS: No genital epithelial toxicity of N-9 vaginal gel was observed. This safety profile suggests that this N-9 product is appropriate for evaluation for human immunodeficiency virus type 1 prevention in a phase III efficacy trial.

Adult↗
PubMed1996

Increased incidence of cancer among homosexual men, New York City and San Francisco, 1978-1990.

Several studies have shown that human immunodeficiency virus type 1 (HIV-1) is associated with an increase in the incidence of Kaposi's sarcoma and non-Hodgkin's lymphoma among homosexual men. The role of HIV-1 in increasing the incidence of other malignancies is more controversial. The incidence of non-Kaposi's sarcoma cancer was examined from 1978 to 1990 among 15,565 homosexual men who participated in studies of hepatitis B virus infection in the late 1970s in New York City, New York, and San Francisco, California. The standardized incidence ratio (SIR) for all cancers was 1.6 (95% confidence interval (CI) 1.4-1.8). Excesses were observed for non-Hodgkin's lymphoma (SIR = 12.7; 95% CI 11.0-14.6). Hodgkin's disease (SIR = 2.5; 95% CI 1.5-3.9), and anal cancer (SIR = 24.2 95% CI 13.5-39.9). As seen with non-Hodgkin's lymphoma, a cancer known to be associated with HIV-1. Hodgkin's disease incidence was significantly higher in more recent years compared with earlier years. No cases of Hodgkin's disease were found among HIV-1 antibody-negative men, and Hodgkin's disease was diagnosed near the time of initial acquired immunodeficiency syndrome diagnoses. Anal cancer incidence did not correlate with HIV-1 antibody status and did not tend to occur near the time of AIDS diagnoses. This study confirms the association of non-Hodgkin's lymphoma with HIV-1 infect on and suggests an association between Hodgkin's disease and HIV-1 infection. An excess in anal cancer was observed but did not appear to be associated with HIV-1 infection.

Acquired Immunodeficiency Syndrome↗
PubMed1996

Placental blood as a source of hematopoietic stem cells for transplantation into unrelated recipients.

BACKGROUND: Transplantation of bone marrow from unrelated donors is limited by a lack of HLA-matched donors and the risk of graft-versus-host disease (GVHD). Placental blood from sibling donors can reconstitute hematopoiesis. We report preliminary results of transplantation using partially HLA-mismatched placental blood from unrelated donors. METHODS: Twenty-five consecutive patients, primarily children, with a variety of malignant and non-malignant conditions received placental blood from unrelated donors and were evaluated for hematologic and immunologic reconstitution and GVHD. HLA matching was performed before transplantation by serologic typing for class I HLA antigens and low-resolution molecular typing for class II HLA alleles. In donor-recipient pairs who differed by no more than one HLA antigen or allele, high-resolution class II HLA typing was done retrospectively. Fordonor-recipient pairs who were mismatched for two HLA antigens or alleles, high-resolution typing was used prospectively to select the best match for HLA-DRB1. RESULTS: Twenty-four of the 25 donor-recipient pairs were discordant for one to three HLA antigens. In 23 of the 25 transplant recipients, the infused hematopoletic stem cells engrafted. Acute grade III GVHD occurred in 2 of the 21 patients who could be evaluated, and 2 patients had chronic GVHD. In vitro proliferative responses of T cells and B cells to plant mitogens were detected 60 days after transplantation. With a median follow-up of 12 1/2 months and a minimal follow-up of 100 days, the overall 100-day survival rate among these patients was 64 percent, and the overall event-free survival was 48 percent. CONCLUSIONS: HLA-mismatched placental blood from unrelated donors is an alternative source of stem cells for hematopoietic reconstitution in children.

Adolescent↗
PubMed1996

Donor levels of serum alanine aminotransferase activity and antibody to hepatitis B core antigen associated with recipient hepatitis C and non-B, non-C outcomes.

BACKGROUND: Hepatitis virus(es) that are neither hepatitis B (HBV) nor hepatitis C (HCV) (non-B, non-C [NBNC]) may be transmitted by transfusion. The present study assessed donor values for alanine aminotransferase (ALT) and antibody to hepatitis B core antigen (anti-HBc) for their association with HCV and NBNC hepatitis outcomes among allogeneic blood recipients. STUDY DESIGN AND METHODS: Data on blood donors and recipients enrolled in the Transfusion- Transmitted Viruses Study in four United States cities from 1974 through 1980 were supplemented by anti-HBc testing of donors and anti-HCV evaluation of recipients. Two statistical approaches estimated the value of these indirect tests in detecting donors associated with HCV seroconversion and NBNC hepatitis in recipients. RESULTS: For HCV cases, donor ALT alone (at > or = 60 IU/L) had a sensitivity and a specificity of 30 and 96 percent, respectively, and anti-HBc alone (at > or = 60% inhibition) had a sensitivity and specificity of 53 and 86 percent, respectively. The two markers combined had a sensitivity and a specificity of 69 and 83 percent. For NBNC hepatitis cases, each measure had low sensitivity (20%) that was not improved by using both (28%) [corrected]. CONCLUSION: The indirect tests proved to be equal in sensitivity to the first-generation anti-HCV tests. The positive predictive power of these indirect tests in the 1980s was sufficient to affect HCV incidence in studies during that period. Improved anti-HCV assays, however, replaced the need for indirect tests. The sensitivity of indirect tests for NBNC hepatitis contributed little.

Alanine Transaminase↗
PubMed1996

Hydrogen peroxide-producing lactobacilli and acquisition of vaginal infections.

This cohort study of 182 women attending a sexually transmitted disease clinic evaluated the hypothesis that women colonized by lactobacilli have decreased acquisition of vaginal infections. During a 2-year follow-up, 50 women acquired bacterial vaginosis (BV), 25 acquired symptomatic vulvovaginal candidiasis (VVC), and 7 acquired vaginal trichomoniasis. By multivariate analysis, utilizing Cox proportional hazards modeling with time-dependent covariates, acquisition of BV was independently associated with lack of vaginal H2O2-producing lactobacilli (hazard ratio [HR] = 4.0, P < .001) or presence of only non-H2O2-producing lactobacilli (HR = 2.2, P = .02). Acquisition of BV was associated with having a new sex partner (HR = 2.5, P = .004) and with douching for hygiene (HR = 2.1, P = .05). Absence of lactobacilli did not increase acquisition of VVC. Trichomoniasis was associated only with having a new sex partner (HR = 4.7, P = .05). These results support the hypothesis that H2O2-producing vaginal lactobacilli protect against acquisition of BV but do not protect against VVC or vaginal trichomoniasis.

Adolescent↗
PubMed1996

The feasibility of HIV-1 vaccine efficacy trials among gay/bisexual men in New York City: Project ACHIEVE. AIDS Community Health Initiative Enroute to the Vaccine EFfort.

OBJECTIVE: Candidate populations for HIV-1 vaccine efficacy trials need to be at high risk of infection, adhere to study protocols and be willing to participate. The goal of Project ACHIEVE is to collect baseline data needed in order to prepare for vaccine efficacy trials among gay/bisexual men in New York City. DESIGN AND METHODS: HIV-1 antibody-negative men were recruited into a cohort study with follow-up visits every 3 months (n = 622). Frequency of high-risk behaviors and incidence of HIV-1 seroconversion were measured. RESULTS: Of 544 men reporting having had at least one partner in the previous 3 months who was HIV-1 antibody-positive or of unknown status at baseline, 49% reported receptive anal sex encounters. Thirty-two per cent of these men reported the highest risk behavior, unprotected receptive anal sex. The follow-up rate at 12 months was 81%. The incidence rate of infection was 2.9 per 100 person-years (95% confidence interval: 1.7, 4.9). During follow-up, declines were observed in the proportion of men with an HIV-1 antibody-positive partner and the proportion reporting unprotected receptive or insertive anal sex. HIV-1 infection rates declined from 4.3 per 100 person-years in the first 6 months to 1.6 per 100 person-years by the 12-month visit. CONCLUSIONS: Gay/bisexual men in New York City are still placing themselves at risk of HIV-1 infection and may be a suitable population for future vaccine trials. Continued follow-up is needed to further define the incidence over time, especially for the period after the initial 3 to 6 months when vaccines are most likely to be effective. Immediate prevention efforts need to target this population more effectively.

AIDS Vaccines↗
PubMed1996

Stability in controlling viral replication identifies long-term nonprogressors as a distinct subgroup among human immunodeficiency virus type 1-infected persons.

Long-term nonprogressors (LTNPs) of human immunodeficiency virus type 1 (HIV-1) infection are characterized by low levels of HIV-1 replication and viral load. However, it has not been established whether they differ in this regard from progressors from the very early stage of infection. By studying peripheral blood mononuclear cell (PBMC) specimens from a longitudinally monitored cohort of HIV-1-infected men, we found that HIV-1 proviral copy numbers and HIV-1 mRNA expression levels as low or lower than those seen in seven carefully selected LTNPs were commonly observed in specimens collected soon after seroconversion from 28 subjects who became infected while under observation. However, only the LTNPs were able to stably maintain such an efficient viral control over time. Because of the instability of the early control of HIV-1 replication, the predictive value of HIV-1 mRNA expression in PBMCs at postseroconversion was found to be limited but significantly increased during the first year of infection. Besides their diagnostic implications, these data support the idea that LTNPs may be a pathophysiologically distinct subgroup among persons infected with HIV-1.

Cohort Studies↗
PubMed1995

HIV-1 messenger RNA in peripheral blood mononuclear cells as an early marker of risk for progression to AIDS.

OBJECTIVE: To establish human immunodeficiency virus type 1 (HIV-1) messenger RNA (mRNA) expression in peripheral blood mononuclear cells as a marker of risk for progression to the acquired immunodeficiency syndrome (AIDS) in a large cohort of HIV-infected persons followed for a prolonged period. DESIGN: Retrospective testing of cryopreserved, coded specimens. SETTING: Research laboratories at the New York Blood Center and the Rockefeller University. PATIENTS: 150 homosexual men infected with HIV-1 who did not have an AIDS diagnosis at the time of testing. MEASUREMENTS: Multiply spliced and unspliced HIV-1 mRNAs in total peripheral blood mononuclear cell RNA were quantitated using reverse transcriptase-initiated polymerase chain reaction (PCR) and compared with other laboratory data and clinical outcome during the subsequent 8 years. RESULTS: Although HIV-1 mRNA expression generally correlated with immunologic status, it was associated with future disease progression independently of CD4+ cell counts or their rate of decrease at the time of sampling. The association of HIV-1 mRNA with disease progression in persons with CD4+ cell counts higher than the median (> 624 cells/mm3) was particularly noteworthy; further variation in the CD4+ cell counts within this group was not prognostically significant. CONCLUSIONS: The expression of HIV-1 mRNA in peripheral blood mononuclear cells is a strong independent marker for future HIV disease progression, even in persons with normal T-cell subsets.

Acquired Immunodeficiency Syndrome↗
PubMed1995

Processing and cryopreservation of placental/umbilical cord blood for unrelated bone marrow reconstitution.

Clinical evidence of hematopoietic restoration with placental/umbilical cord blood (PCB) grafts indicates that PCB can be a useful source of hematopoietic stem cells for routine bone marrow reconstitution. In the unrelated setting, human leukocyte antigen (HLA)-matched donors must be obtained for candidate patients and, hence, large panels of frozen HLA-typed PCB units must be established. The large volume of unprocessed units, consisting mostly of red blood cells, plasma, and cryopreservation medium, poses a serious difficulty in this effort because storage space in liquid nitrogen is limited and costly. We report here that almost all the hematopoietic colony-forming cells present in PCB units can be recovered in a uniform volume of 20 ml by using rouleaux formation induced by hydroxyethyl starch and centrifugation to reduce the bulk of erythrocytes and plasma and, thus, concentrate leukocytes. This method multiples the number of units that can be stored in the same freezer space as much as 10-fold depending on the format of the storage system. We have also investigated the proportion of functional stem/progenitor cells initially present that are actually available to the recipient when thawed cryopreserved PCB units are infused. Progenitor cell viability is measurably decreased when thawed cells, still suspended in hypertonic cryopreservative solutions, are rapidly mixed with large volumes of isotonic solutions or plasma. The osmotic damage inflicted by the severe solute concentration gradient, however, can be averted by a simple 2-fold dilution after thawing, providing almost total recovery of viable hematopoietic progenitor cells.

Blood Cell Count↗
PubMed1995

Determinants of cervical ectopia and of cervicitis: age, oral contraception, specific cervical infection, smoking, and douching.

OBJECTIVE: Our purpose was to assess determinants of cervical ectopia and cervicitis, specifically after adjustment for cervical infection. STUDY DESIGN: A cross-sectional study was conducted with colposcopic, cytologic, and microbiologic examination of 764 randomly selected women attending a sexually transmitted disease clinic and 819 consecutive college students undergoing routine annual examination. RESULTS: After we controlled for potential confounders, cervical ectopia was positively associated with oral contraception and Chlamydia trachomatis infection and negatively associated with aging in both populations, with recent vaginal douching in patients with sexually transmitted diseases, and with current smoking in college students. Oral contraception wa also associated with the radius of ectopia, and among users of oral contraception ectopia was associated with duration of oral contraception. Cervicitis (evaluated by Gram stain, Papanicoloau smear, and colposcopy) was associated with cervical infection by C. trachomatis and cytomegalovirus (both populations) and with gonorrhea and cervical herpes simplex virus infection (patients with sexually transmitted diseases). Cervicitis was independently associated with ectopia but not with oral contraception after we adjusted for these four cervical infections. However, oral contraception was associated with edema and erythema of the zone of ectopia among women without cervical infection. CONCLUSIONS: Oral contraception, aging, cervical infection, smoking, and douching have effects on cervical ectopia that may influence the acquisition, transmission, or effects of sexually transmitted agents. Ectopia is associated with young age, oral contraception, and cervical infection; cervicitis is associated with ectopia and cervical infection by C. trachomatis, Neisseria gonorrhoeae, herpes simplex virus, and cytomegalovirus. In women without cervical infection, edema and erythema of the zone of ectopia are associated with oral contraception.

Adolescent↗
PubMed1995

The inflammatory Papanicolaou smear: what does it mean?

OBJECTIVE: To determine the correlation between inflammation detected on Papanicolaou smear and specific lower genital tract agents, and, based on these findings, to develop recommendations for follow-up tests and treatment of young women with inflammation on smears. METHODS: A high-risk population of 779 randomly selected women attending a sexually transmitted disease (STD) clinic and a low-risk population of 1050 consecutive women presenting for annual examination at a university student health center underwent a standardized history and gynecologic examination. Univariate and multivariate analyses, focusing on the association between dense inflammation on Papanicolaou smear and specific lower genital tract pathogens or findings on cervical examination, were done for each population. RESULTS: Dense inflammation was present on the Papanicolaou smear of 256 (33%) of the 779 women in the STD clinic and 200 (19%) of 1050 students. Dense inflammation on Papanicolaou smear was independently associated with mucopus, cervical ectopy, cervical infection with Neisseria gonorrhoeae, Chlamydia trachomatis, herpes simplex virus (HSV), and vaginal infection by Trichomonas vaginalis in the STD population; in the student population, it was associated with cervical ectopy, C trachomatis, and mucopus. CONCLUSION: Although dense inflammation on Papanicolaou smear was a common finding in both the high- and low-risk populations, about half of the inflammation detected in the high-risk setting was associated with a specific microbial organism (C trachomatis, N gonorrhoeae, HSV, or T vaginalis), whereas less than 10% of the dense inflammation detected in the low-risk setting was linked with a specific pathogen (C trachomatis). In both settings, a substantial population of sexually active women had dense inflammation associated with cervical ectopy but none of the specific organisms evaluated in this study.

Adult↗
PubMed1995

Donor screening for antibody to hepatitis B core antigen and hepatitis B virus infection in transfusion recipients.

BACKGROUND: Testing for antibody to hepatitis B core antigen (anti-HBc) as a surrogate for hepatitis C viremia is no longer needed for blood donor screening. Currently, the important question is how much its use supplements hepatitis B surface antigen (HBsAg) donor screening in preventing transfusion-transmitted hepatitis B virus (HBV) infection. STUDY DESIGN AND METHODS: In a study conducted in the 1970s, 64 blood donors were associated with 15 cases of HBV (1.0%) in 1533 transfusion recipients. Sera from 61 donors at donation and 29 follow-up visits were available for present-day assays for HBsAg, HBV DNA, anti-HBc, and antibody to HBsAg (anti-HBs). RESULTS: HBsAg was found in four previously negative blood donors; HBV DNA was limited to three of these four. Anti-HBc was detected in six HBsAg-negative donors. Two other donors were negative in all assays at donation, but positive for anti-HBc and anti-HBs 2 to 4 months later. The remaining donors were negative for all HBV markers, which left five recipient cases unexplained. No HBV transmission was observed when anti-HBs sample-to-negative control values were > or = 10. CONCLUSION: Some 33 to 50 percent of cases of hepatitis B that could be transmitted by transfusion of blood from HBsAg-negative donors are prevented by anti-HBc screening. Anti-HBc-positive donors unequivocally positive for anti-HBs should be considered noninfectious for HBV and should be allowed to donate. Anti-HBc screening of paid plasmapheresis donors, supplemented by anti-HBs testing, would reduce the amount of HBV to be processed by virus inactivation and increase the content of anti-HBs in plasma pools.

Blood Donors↗
PubMed1995

Human immunodeficiency virus type 1 infection: relationship of risk group and age to rate of progression to AIDS. Transfusion Safety Study Group.

Age differences among risk groups may account for rate differences in progression of human immunodeficiency virus type 1 (HIV-1) infection to AIDS. Institutions in 6 US cities used a common protocol to study infected homosexual blood donors, recipients of blood components, and factor VIII-treated hemophiliacs. Follow-up was every 6 months. Actuarial risk for AIDS 8 years after infection was 51% among blood recipients, 36% among homosexual donors, and 24% among hemophiliacs. Significant risk group differences were explained by age differences among cohorts (medians of 61, 29, and 22 years, respectively). When age was adjusted for and both CD4 cell value and zidovudine treatment were used as time-dependent covariates, homosexual donors had more rapid progression than the other groups. Omitting Kaposi's sarcoma as an AIDS-defining condition removed any significant differences among risk groups except CD4 cell count and age. Thus, major factors in AIDS progression are age-related.

Acquired Immunodeficiency Syndrome↗