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Safety of switching to nevirapine-based highly active antiretroviral therapy at elevated CD4 cell counts in a resource-constrained setting [letter]
Journal of Acquired Immune Deficiency Syndromes. 2007 Aug 15; 45(5):598-600.The World Health Organization recommends the use of generic nevirapine (NVP)/efavirenz (EFV)-based highly active antiretroviral therapy (HAART) regimens as first-line therapy in the management of HIV in resource-limited settings. Initiating NVP-based HAART at elevated CD4 cell counts can lead to liver toxicity. Short-term risk of liver toxicity has been reported in men with CD4 counts greater than 400 cells/mL and in women with CD4 counts greater than 250 cells/mL. Hence, clinicians are advised to monitor the results of liver chemistry tests closely in the first 18 weeks of therapy because of the potential to develop life-threatening hepatic events. Mocroft et al showed that initiating NVP therapy at elevated CD4 levels may be safe for use in antiretroviral-experienced patients. Little is known about short-term adverse consequences and clinical outcome at elevated CD4 cell counts in a resource-limited setting. (author's)
PROGRESS IN HUMAN REPRODUCTION RESEARCH. 1992; (22):8.The WHO Special Programme on Research, Development and Research Training in Human Reproduction and diagnostic companies conduct research into the development of a simple, accurate, robust, home based method which predicts ovulation. A prolonged rise in the excretion product of estradiol in the uterine indicates that ovulation will soon follow A similar rise in serum estradiol levels also occurs several days before ovulation. Researchers in Melbourne, Australia have created an uncomplicated tool to measure the most plentiful estradiol excretion product, estrone glucuronide, and the progesterone excretion product, pregnanediol glucuronide, whose rising levels indicate the end of the fertile period. In 1991, WHO and the Australian researchers began a multicenter studying comparing this instrument with the sign and symptoms observed in traditional natural family planning methods. As of mid 1992, results were not yet available. The ability to determine the beginning and the end of the fertile period makes this potential tool especially promising. WHO is supporting another multicenter study testing for a decline of the enzyme guaiacol peroxidase in cervical mucus as a marker of approaching ovulation. It is difficult to test for forthcoming ovulation in premenopausal women, because they do not always ovulate their menstrual cycles. A WHO study looked at the association between ovarian hormone secretion an symptothermal indicators of fertility in 36 premenopausal women (177 menstrual cycles). Around 33% of the women regular menstrual cycles that may have been fertile, around 19% experienced no hormonal changes indicating fertility during their cycles, and the rest of the woman had a combination of both. Further traditional symptothermal markers could not distinguish the 2 different types of cycles.
The WHO Task Force on Vaccines for Fertility Regulation. Its formation, objectives and research activities.
HUMAN REPRODUCTION. 1991 Jan; 6(1):166-72.The WHO Task Force on Vaccines for Fertility Regulation is one of several Task Forces, consisting of international, multidisciplinary groups of scientists and clinicians collaborating in research on specific goals, established in 1972. Its accomplishments are reviewed here. The Task Force convened a meeting in 1974 to select criteria for tissues and molecules capable of mounting antifertility responses. These molecules had to be restricted to the target tissue, sequestered in the reproductive tract, present transiently, and chemically characterized. Some of the antigens considered were sperm enzymes and membranes, as well as a data bank of sera naturally immunized against sperm. Other were anti-ovum and placenta molecules such as zona pellucida, the SP-1 placental antigen, and the placental hormones chorionic somatotrophin and human chorionic gonadotropin (hCH). Trophoblast-derived monoclonal antibodies and gene libraries are being screened. Anti-hCH is the vaccine composed of a portion of the beta subunit complexed to a carrier antigen, diphtheria toxoid, in a water- oil emulsion with an adjuvant has been tested in a phase I clinical trial in 1986-1988. A Phase II trial is being planned to see if the immune response in women is large enough to be capable of preventing pregnancy. Further improvements in the vaccine are being envisioned, such as incorporation of the peptide carrier conjugate and immune stimulant into biodegradable microspheres, hopefully to produce a longer-lasting immunity and a more stable vaccine. While the WHO Task Force on Vaccines for Fertility Regulation has been forced to cut back on some avenues of research, its success has stimulated other centers to take up several important projects, e.g. the sperm LDH and zona pellucida vaccines.
PROGRESS IN CLINICAL AND BIOLOGICAL RESEARCH. 1988; 285:331-41.The applicability of both radioimmunoassay and non-radiometric assay methods for use in research and clinical laboratories in developing countries are reviewed. The WHO Special Program of Research in Human Reproduction has distributed radioimmunoassay reagents to laboratories collaborating on fertility research for >10 years, but it is predicted that non-radiometric methods will be used in the near future. Some of the qualities required by sites in developing countries are stability at high temperatures, low cost, simple procedures, simple and non-dedicated instrumentation or none at all, ease of local manufacture or practical distribution and supply, and small, practical storage requirements. Biological samples should not require invasive procedures. Assay time must be brief if patients are waiting, but it is usually not possible to handle large sample volumes to same time. Radioisotopes have the advantage of affecting the kinetics of the test reaction to a lesser extent than non-radiometric assays, but they do required separation of bound from free hormone. Radioimmunoassays also can be repeated, while many non-radiometric assays are destroyed in the assay procedure. Time-resolved fluorescence assays are a good choice for the medium term.
JAMA. 1988 Dec 9; 260(22):3286-9.In Africa, as in many developing countries where AIDS has been documented, the specific serologic test for antibody to the human immunodeficiency virus is not feasible, and the case definition of the Centers for Disease Control is impracticable because facilities for diagnosing the opportunistic infections are inadequate and the clinical spectrum of AIDS is different in tropical countries. The World Health Organization developed a clinical case definition at a 1985 AIDS workshop in the Central African Republic. It was tested to determine its generalizability in Zaire, and the present paper is a report on experience using the definition to identify AIDS in Uganda. A clinical case of AIDS is defined by the presence of at least 2 major signs and 1 minor sign. The major signs are fever for more than 1 month, weight loss greater than 10%, and chronic diarrhea for more than 1 month. The minor signs are persistent cough for more than 1 month, pruritic dermatitis, herpes zoster, oropharyngeal candidiasis, ulcerated herpes simplex, and general lymphadenopathy. The presence of disseminated Kaposi's sarcoma or disseminated cryptococcosis is sufficient by itself to diagnose AIDS. The Uganda study included 1328 patients at 15 hospitals. 562 patients (42%) tested positive by enzyme-linked immunosorbent assay, and 776 (58%) tested negative. 424 patients (32%) met the world Health Organization clinical case definition for AIDS. The World Health Organization definition had a sensitivity of 55%, a specificity of 85%, and a positive predictive value of 73%. However, so many of the patients in this sample had active tuberculosis that it was decided to substitute "persistent cough for more than 1 month without concurrent tuberculosis" as a minor sign in place of "cough for longer than 1 month." With this modification 350 patients met the clinical case definition for AIDS. Sensitivity dropped to 52%, but specificity rose to 92%, and positive predictive value rose to 83%. Moreover, 26% of the seropositive females indicated amenorrhea as a symptom. Addition of amenorrhea to the modified case definition gave it a sensitivity of 56%, a specificity of 93%, and a positive predictive value of 86%. However, this is the 1st report of amenorrhea as a symptom of AIDS, and it may only be a symptom of severe weight loss in women of childbearing age. The findings in the Ugandan experience support the generalizability of the modified World Health Organization clinical case definition of AIDS and its use for surveillance purposes in Africa.
Bulletin of the World Health Organization. 1978; 56(2):179-192.Strong evidence that specific immunogenic components of the reproductive system exist that are not represented in other body systems has led to efforts to develop an acceptable vaccine for fertility regulation. The aim is to create a vaccine administered infrequently by trained technicians outside the clinical environment. For safety and practical reasons, an approach using active immunization with a vaccine is preferred to passive immunization with antibodies. In current research with sperm antigens, a lactate dehydrogenase isoenzyme (LDH-X), an enzyme normally present on the sperm surface, reduced fertility in mice and rabbits. However, significant embryo mortality occurred. Other sperm antigens have been tested and rejected. Most of the research on ovum antigens is directed toward the zona pellucida, and work is in progress to isolate experimental quantities of specific zona pellucida antigens. Antibodies to human zona are reported to react with pig zona and vice versa, providing a model system. Antibodies to whole-placenta homogenates reportedly disrupt pregnancy in several laboratory animal species, and 2 placenta-specific proteins are potential antigens since antibodies to them do not react with any other tissue so far tested. Of 3 protein hormones isolated from placental tissue, 2 are potential antigens. The possible hazards of antifertility vaccines can be divided into 2 categories: problems related to immunization and problems caused by antibodies produced.
Acta Paediatrica Scandinavica. 1978 September; 67(5):553-582.6 research articles plus an introduction constitute this review of present knowledge of lactation and its effects. The superiority of human milk as compared with milk of other origin for feeding newborns, term or preterm, was analyzed in terms of biological development related to digestive, metabolic, and excretory functions during fetal and postnatal life in the 1st article. WHO, concerned with the declining breast feeding rate in developing countries, has organized investigations in 9 different countries of different aspects of breast feeding and breast milk with the aim of formulating programs of intervention. Basic epidemiological data on 24,000 mother/child pairs have just been reported in a preliminary manner, emphasizing socioeconomic differences. The 3rd study investigated the nitrogen and protein components of human milk; the true protein content of human milk is .9% in both well-nourished and malnourished mothers. The next study reviewed lipid and trace element composition of human milk in relation to ethnic variables. Contaminants in human milk are characterized in the next review, with DDT and PCBs the most outstanding. The final article emphasizes new knowledge in human milk immunoglobulin, the most predominant of which is secretory IgA.
Indian Journal of Medical Research. October 1978; 68(Suppl):80-87.Cross-sectional and longitudinal studies were made to assess vitamin nutritional status of women using oral contraceptives (OCs). In the cross-sectional study, data obtained on 20 women, who had used Ovulen 50 for 6-12 months, were compared with data obtained on matched controls who had never used OCs. In the longitudinal study, 23 women were examined initially (before OC use) and again at 1 or more points during the next 6 months of OC use. Changes were found in several parameters of nutrition tested. 1) OC use produced a highly significant rise in plasma vitamin A within 1 month of treatment. 2) Thiamine activity measurements showed a slight fall, but did not affect the TPP effect, suggesting that OCs did not seriously alter thiamine status. 3) Erythrocyte riboflavin concentration showed a fall, revealing a very high incidence (> 80%) of biochemical riboflavin deficiency in women before starting OCs which was further reduced after treatment. 4) There was a marked rise in urinary excretion of xanthuremic and kynurenic acids after a standard tryptophan load, indicating impaired tryptophan metabolism due to pyridoxine deficiency. 5) Erythrocyte folate levels showed a small but significant fall. These observations on Indian women belonging to low income groups show clearly that OC use does affect the vitamin economy of the body adversely. Biochemical evidence presented argues that OCs alter vitamin economy through rise in levels of some proteins which bind vitamins. Vitamin supplements are recommended not only for patient benefit but for program acceptability.
In: World Health Organization (WHO). World Health Organization expanded programme of research, development, and research training in human reproduction: fourth annual report. Geneva, Switzerland, WHO, November 1975. 51-5. (HRP/75.3)2 years ago an exploratory program of possible vaccines for birth control was initiated. The approach is totally new and it is impossible to predict the outcome. Research on placental antigens has focused on the beta subunit of human chorionic gonadotropin (HCG), a placental-specific protein called SP1, a placental-specific glycoprotein called PP5, and several protein conjugates and adjuvants which use the beta chain of insulin with carrier proteins to synthesize beta-HCG. Details of this research are given. Considerable data suggest that antibodies to several substances in spermatozoa may immobilize, agglutinate, or destroy their biological activity. Sperm enzyme antigens being investigated include lactic dehydrogenase-X, hyaluronidase, and acrosin. These are given to the female; tests have shown fertility reductions up to 50%. Sperm membrane antigens are difficult to isolate but may be more suitable immunogens since they are membrane bound and would not have the problems of circulating immune complexes or nonspecific tissue cross-reactivity. These include "T" and "S" antigens, sperm immobilizing antigen, and carbohydrate antigens. Various antigen/carrier/adjuvant combinations will also be evaluated. Zona pellucida antigens are another research target, especially zone surface antigens. A workshop was organized to consider the production of local immunity in the female genital tract. Since infertility in humans attributed to immunological factors may hold useful information, a bank of sera from infertile men and women has been established in Arhus, Denmark. A symposium on immunological methods of fertility regulation was held in Bulgaria and the papers published as a monograph.