The Weekly NewsDigest is a compilation of HIV prevention research media coverage and relevant science in peer-reviewed journals; material on
other reproductive health issues; and matters of policy and politics relevant to HIV prevention research, development and advocacy.
Its purpose is to raise awareness around the range of opinions and information about HIV prevention research disseminated in the press and
scientific journals and provide a neutral, objective basis for decision-making and evidence-based advocacy.
There were three scans of Francis Collins's genome, and all showed the same thing: the geneticist and physician has an increased risk of developing type 2 diabetes. After Collins received the results from the genetic-testing companies in the spring of 2009, shortly before he became director of the US National Institutes of Health (NIH), he hired a personal trainer and began working out three times a week. He jettisoned his favourite junk food -- honey buns and oversized muffins -- in exchange for yoghurt, granola bars and broccoli. The 60-year-old now dead lifts 48 kilograms, chest presses 43, and has lost more than 11 kilograms himself. "It has helped me a lot in terms of being able to take on the intensity of the job," he says.
That salubrious slimming is nothing compared with the crash diet that Collins's US$31-billion-a-year agency is about to go on. Collins took control of the NIH -- the world's largest biomedical-research funder -- in the middle of a feast: a $10.4-billion, two-year boon delivered in 2009 by the American Recovery and Reinvestment Act, as part of the US government's effort to revive a moribund economy. Next month, the last of that money will go out of the door, and its recipients will have spent the bulk of it by September 2011. "The Recovery Act provided an enormously timely and appropriate stimulus for the community after five years of flat funding," Collins said in an interview with Nature at the NIH's Bethesda, Maryland, campus last month. "But now we face this potential of falling off a cliff. That's the biggest challenge" of his job, he says.
The pharmaceutical industry, having helped Democrats pass the biggest health bill in a generation, now is hedging its bets. The industry's main lobby, the Pharmaceutical Research and Manufacturers of America, in July hired a new chief, John Castellani, from the Business Roundtable, a group of corporate executives that has recently turned to attacking the Obama administration.Mr. Castellani inherits a group that swung to the Democratic Party during 5.5 years under Billy Tauzin, a former U.S. representative from Louisiana. Mr. Tauzin, a Republican who started in Congress as a Democrat, found an industry with a tattered reputation, known to the public mainly for high prices, safety scandals and erectile-dysfunction ads on television.
"When Billy took over PhRMA, the industry had a trust deficit," said Richard Clark, chief executive of Merck & Co. Mr. Tauzin's challenge deepened in 2006 when Democrats won control of Congress from Republicans, the party to which PhRMA was long allied. His answer was to embrace some of the criticism and shift political contributions toward Democrats. Mr. Tauzin pushed his companies to give away drugs to people who couldn't afford them, courted the seniors' lobby AARP and wooed labor leaders such as Andrew Stern of the service workers' union.
The EMA and FDA are seeking pharma manufacturers to participate in a joint GMP (good manufacturing practice) inspection pilot programme. Joint inspections are intended to better use resources, allowing for more sites to be monitored and reducing unnecessary duplication. To test the concept EU and US regulatory bodies are seeking companies requesting pre-approval in both regions to participate in a pilot programme. Applicants to the programme could have their manufacturing facilities jointly inspected by the European Medicines Agency (EMA) and US Food and Drug Administration (FDA). Before this point is reached the regulatory agencies must work through a number of steps. These include the establishment of contact points, teleconferencing to agree the scope and details of the inspection and deciding which agency will be the lead authority. In the US the FDA leads, in the EU the EMA leads and overseas it is decided on a case-by-case basis.
The Obama administration is focused not just on health-care reform in the United States -- but also on improving health care systems around the world, Secretary of State Hillary Clinton announced on Monday. The new plan has a "woman- and girl-centered approach," according to an administration fact sheet.
Speaking at Johns Hopkins University, Clinton outlined the six-year, $63-billion Obama administration initiative to bring global health care services "to more people in more places." The administration's Global Health Initiative has "everything" to do with foreign policy, she said. "This is a signature of American leadership in the world today, Clinton said. "It's also an issue very close to my own heart."
Clinton said in her world travels, she's met "countless people who are proof of what successful global health programs can do." She mentioned HIV-positive farmers in Kenya who are able to continue farming, thanks to antiretroviral drugs; children in Angola who now sleep under bed nets to ward off malaria; mothers of healthy babies who were delivered by trained midwives; and people who survived into adulthood because of childhood immunizations.
Clinton then outlined the "new approach" to global health care, which is aimed at "saving the greatest possible number of lives" by expanding existing health programs "to help countries develop their own capacity to improve the health of their own people."
Clinton said the administration's Global Health Initiative (GHI) would build on the groundbreaking work of the George W. Bush administration's PEPFAR program (President's Emergency Plan For AIDS Relief). The Obama administration, Clinton said, will expand the PEPFAR program to provide anti-AIDS retroviral drugs to more people in developing countries.
The new GHI programs will have what the Obama administration describes as a "woman-centered" approach, providing funding for neonatal care, family planning services, and infant health care.
Starpharma Holdings has commenced a phase 2 study of VivaGel(R) for the treatment of bacterial vaginosis, following receipt of ethics approval. Dr Jackie Fairley, Chief Executive Officer of Starpharma, said: "The commencement of this study is an important step in the development of VivaGel(R). Experts in this field have indicated there is a desperate need for new treatment options for BV."
Starpharma announced in July 2010 that the US Food and Drug Administration (FDA) had accepted and cleared its investigational new drug application (IND) for the study. Clinical trial sites in the US will be initiated this week and will commence enrolment of participants immediately. This phase of the clinical program will investigate the treatment of BV with a once daily for seven days treatment of VivaGel(R) and its findings will guide further investigation of its use in both treatment and suppression of recurrence.
NanoViricides Inc., a Connecticut developer of drugs to fight challenging infectious diseases, has reported almost complete inhibition of the Herpes virus following a study of the company's anti-Herpes drug targets. The West Haven, Conn.-based company plans to develop an ointment form of a treatment for cold sores or genital herpes simplex virus infections. Its nanoviricide nanomicelle drug is designed to bind to the virus and break it down, making it non-infectious. The cell culture studies took place at Northeastern Ohio Universities' Colleges of Medicine and Pharmacy and was carried out using with the virulent H129 strain of herpes, as opposed to the simplex virus type 1 (HSV-1).
In a country with the highest HIV infection rate in the world and the lowest life expectancy, experts are still at a loss as to why Swazis have resisted all attempts to change the behaviours that put them at risk from the virus. The ABC (Abstain, Be Faithful, Condomise) approach has guided Swaziland's HIV prevention efforts for years, but has dismally failed to slow the spread of the virus. "If you look at the increase of HIV in the country while we've been applying the ABC concept all these years, then it is evident that ABC is not the answer," said Dr Derek von Wissell, Director of the National Emergency Response Council on HIV/AIDS (NERCHA).
Von Wissell has called for new approaches and is hoping to get some answers from a countrywide study looking into Swazis' sexual behaviour being undertaken with the assistance of the World Bank. Results from the study may reveal what motivates sexual risk-taking, and suggest ways to curtail it. "Ultimately, behaviour is what has to change ... because ... commitment to relationships is very low - we need to look at the nature of relationships," he told IRIN/PlusNews.
Countries in southern Africa are producing so few scientific publications and patents that the region's social and economic progress is threatened, and it could fail to meet its Millennium Development Goals, says a study. The South African Development Community (SADC), comprising 15 countries, produced only around 0.7 per cent of the world's share of scientific publications between 2004 and 2008. In comparison, India produced 2.9 per cent and Latin American countries 4.1 per cent of the world's output in the same period. About 79 per cent of SADC's publications came from South Africa but the country spent less than 1 per cent of its GDP on research and development compared with 3-4 per cent by more developed countries. The next most productive country, although 14 times less productive than South Africa, was Tanzania, but Mozambique and the Seychelles showed the highest growth at almost 80 per cent, while output from the Democratic Republic of Congo and Zimbabwe has declined since 1998.
TRI has been awarded a contract with the US NIAID to provide clinical, regulatory and operational support for domestic and overseas HIV research. Having inked the contract Technical Resources International (TRI) will provide a range of services to support research into HIV. For the services TRI has received an initial $9.0m (Euro 7.0m). Over the next seven years the contract has a potential total value of $75.3m. In exchange TRI will review protocol documents and prepare and file investigational new drug (IND) applications. TRI will also review existing INDs in compliance with regulatory procedures, assess informed consents and process essential documents for protocol registration. Other tasks covered by the contract include the collection, processing and preparation of adverse event reports for the US Food and Drug Administration (FDA).
The Salk Institute in La Jolla will lead a $21 million effort to clarify how the body's immune system responds immediately after it is exposed to the AIDS virus, a process that is not well understood despite the creation of drugs that effectively fights the disease in many people. More than a dozen research groups from six institutions -- including teams from UC San Diego and Sanford-Burnham -- will join Salk in a study that will broadly look at how proteins work at the cellular level to mount a defense against the virus. The consortium's work is being funded by the National Institutes of Health in hopes that it will lead to new and better therapies, and possibly an explanation of why some people are more susceptible to infection than others. The study will be led by Salk immunologist John Young, a nationally-renowned expert in infectious diseases, and by Sumit Chanda, a noted geneticist at the Sanford-Burnham Medical Research Institute in La Jolla.
There were cheers and some tears at the International AIDS Conference in Vienna in July when delegates heard the news that a clinical trial in South Africa, had found a vaginal gel containing the antiretroviral drug, tenofovir, was 39 percent effective at reducing women's risk of contracting HIV during sex.
"There were tears from many people -- tears of happiness that finally there is something we can work towards -- and a lot of tears of sadness for all of the women whose lives have been lost waiting for a microbicide," Dr Zeda Rosenberg recalled at a recent meeting in Johannesburg, South Africa, hosted by the International Partnership for Microbicides (IPM), a non-profit organization.
IPM is involved in coordinating and funding the long process of developing effective microbicides -- products that women can apply vaginally to protect themselves against HIV -- and making sure they reach the women in developing countries who most need them. Rosenberg, who has been working in the field of HIV prevention research for more than two decades and is CEO of IPM, talked to IRIN/PlusNews after the meeting.
Biopharmaceutical manufacturer Gilead Sciences Inc. is known for its developments in the areas of HIV/AIDS, liver disease and serious cardiovascular and respiratory conditions. In 2006 the Foster City, Calif., company introduced the first once-daily single-tablet regimen for adult HIV treatment called Atripla. The 46th-ranked company on the IW Best Manufacturing Companies list has achieved significant gains over the years, including crossing the $7 billion revenue mark in 2009. Profit grew nearly 31% in 2009, and the company's 37.5% profit margin and 63% return on equity were well above IW 50 Best averages.
But as noted in an Ockham Research financial blog, concerns about the "lack of promising blockbusters" has contributed to stock falling 31% over a 12-month period. That could change, though, as a promising breakthrough for HIV treatment gains traction. A gel-formed version of a drug developed by Gilead called tenofovir may significantly reduce a woman's risk of being infected with HIV and genital herpes, according to study results released July 20 by the Centre for the AIDS Programme of Research (CAPRISA) in South Africa.
Despite a worldwide campaign for circumcision to slow the spread of AIDS, the rate of circumcision among American baby boys appears to be declining. A little-noted presentation by a federal health researcher last month at the International AIDS Conference in Vienna suggested that the rate had fallen precipitously -- to fewer than half of all boys born in conventional hospitals from 2006 to 2009, from about two-thirds through the 1980s and '90s.
Last week, officials at the Centers for Disease Control and Prevention cautioned that the figures in the presentation were not definitive. But they are already stirring a sharp debate on the Internet. The numbers were presented to the AIDS conference by a C.D.C. researcher, Charbel E. El Bcheraoui. The presentation was not covered by any mainstream news outlets, but a report by the news service Elsevier Global Medical News, along with a photograph of a slide from the presentation, quickly made the rounds of the blogosphere.
Opinion on routine circumcision for boys is already divided across the world, but recent research is sparking fresh debate. The American Academy of Pediatrics is assessing the mass of evidence that has become available since it took the position, in 1999, that although there may be "potential medical benefits... these data are not sufficient to recommend routine neonatal circumcision." The academy plans to publish its updated position later this year amid growing pressure from both sides of the debate.
Campaign groups have emerged worldwide, both within religious communities who traditionally practise circumcision and outside, where groups argue that the tradition of circumcising infants for non-medical reasons amounts to a violation of the rights of the child.
Women leaders in South Africa have hailed the outcome of a microbicide gel study, saying it will help protect women who can't negotiate safe sex with their partners against HIV infection.
As the country marks Women's Month, a milestone is being celebrated. The search for a microbicide, which will ultimately afford many women the ability to protect themselves from getting HIV, is showing promising results. Scientists recently announced the outcome of a study that involved a vaginal gel containing an antiretroviral drug called Tenofovir, which demonstrated that it can protect women from acquiring HIV infection by about 39%. Dr Zeda Rosenberg of the International Partnership for Microbicides says this is an unusual approach of using an antiretroviral drug as a preventative agent.
"Antiretroviral drugs, when adapted for microbicides, could prevent infection, not just treat infection. We are all familiar with ARVs and how they can help bring people back to life...that are infected with HIV, once the virus has spread in the body. But, microbicides are products that are designed to prevent the virus from taking hold in the body, stopping it at a very early point in the life-cycle of HIV".
Dr Rosenberg said women continue to bear the brunt of HIV infection as many are not able to negotiate safe sex. The outcome of the study has been hailed as a tool that will give hope to many women who don't have a say on whether or not their partners use protection during intercourse. Dr Nono Simelela, Chief Executive Officer of the South African National AIDS Council (SANAC) welcomed the study's findings, but raised concerns that women are almost like second-class citizens in South Africa.
Intensifying their search for a vaccine to prevent HIV infection, scientists are planning to run an improved version of the successful Thai HIV vaccine trial in South Africa next year.
News from Thailand late last year that a vaccine trial conducted among 16 000 Thais gave a 31% protection rate against HIV infection has given scientists hope that their quest to find a vaccine to prevent HIV infection is on the horizon. But further tests are needed and South Africa is an obvious place for these to be run, given our high HIV rate.
"There was a clinical trial that was done in Thailand and the results were reported in October last year that, for the first time, showed a hint that we'll be able to protect people from HIV by vaccination. We're really building on those findings and there are big plans to repeat those trials, both in South Africa and elsewhere, and, of course, improve on those, but to really see whether these first signs are really something that we can use to make a better vaccine", explained Lynn Morris, a Wits University professor and researcher for the National Institutes of Communicable Diseases (NICD), adding that "the Thai trial showed that the vaccine in question had a protective rate of 31%".
But "that's a very low percentage and certainly not high enough for one to implement that vaccine. It's not good enough for use, but it's good enough to explore further", Morris said explaining why further studies using the Thai vaccine model will be carried out in South Africa.
Officials with the Siberia-based State Research Center for Virology and Biotechnology, Vector, reported that they have successfully accomplished development of a candidate HIV vaccine. Vector officials told EurasiaReview.com that they have obtained permission to test the new treatment. Researchers at the facility, which is located in the Siberian city of Novosibirsk, told EurasiaReview.com that they have been carrying out a vast amount of scientific research aimed at developing an HIV vaccine since 2008.
Vector officials said the vaccine is one of the strongest and most advanced vaccines in the world. "This vaccine induces strong antibody response and the formed antibodies not only recognize HIV-1 antigens but can also neutralize the virus in vitro," an unnamed source told EurasiaReview.com. Officials estimated the first phase of vaccine tests on human volunteers should be completed in 2010.
IT is 3:30am on a humid early Thursday morning at St Theresa's Mission Hospital in Chirumhanzu District in the country's Midlands province. Everyone in the wards and staff residences is still asleep, except for a few night-shift nurses and a lone man puffing a cigarette at his desk in the hospital's laboratory. In front of him are sealed boxes inscribed PMTCT Mvuma, St Theresa's, Muonde and Holy Cross outreach. A desk fan that keeps him awake blows off some sheets of paper on his desk.
The man picks up the sheets and then wipes off sweat rolling down his forehead. He opens one of the boxes, pulls out a test tube and inserts it into a CD4 count machine. As he monitors the machine, he pulls out yet another cigarette from a pack on his desk while the wall clock ticks away towards yet another hectic day ahead, which will see him going out on an outreach programme with other members of the Anti-retroviral Therapy (ART) team.
Such is the nature of work and sacrifice that Simbarashe Chirasha, the only laboratory scientist at the hospital, has to put up with to cope with the increasing demand for HIV and Aids services in the district due to increased awareness programmes. He has had to endure sleepless nights to ensure that he determines the HIV status of thousands of people going for tests at some health centres in the district. This trend is the same nationwide for personnel involved in the ART programme who comprise of doctors, primary care counsellors, nurses, pharmacy technicians and laboratory scientists.
In recent years, scientists have studied the possibility of using engineered human adenoviruses as vaccines against diseases such as HIV, tuberculosis, and malaria. In this approach, adenoviruses, which commonly cause respiratory-tract infections, are rendered relatively harmless before they are used as vectors to deliver genes from pathogens, which in turn stimulate the body to generate a protective immune response.
In a new study of four adenovirus vectors, researchers from The Wistar Institute show that a reportedly rare human adenovirus, called AdHu26, is not so rare, after all, and would thus be unlikely to be optimal as a vaccine carrier for mass vaccination. As previous research has shown, a viral vector may be ineffective if the virus it is based on is common in a given population. According to the Wistar scientists, their study also supports the use of chimpanzee adenoviruses as vaccine vectors, since humans have little exposure to these viruses. Their findings were published online, ahead of print, in the Journal of Virology.
To read the full article on this study in the Journal of Virology, see: Chen H, Xiang ZQ, Li Y, Kurupati RK, et al. Adenovirus-Based Vaccines: Comparison of Vectors from Three Families of Adenovirideae. Journal of Virology, 2010; DOI: 10.1128/JVI.00450-10.
Australian bio-pharmaceutical company, Virax, has announced that the phase I/IIa clinical trial for its VIR201 HIV vaccine did not meet its primary or secondary immunological endpoints. The trial, in South Africa, was conducted on 131 patients, with 65 patients undergoing antiretroviral (ART) treatment and 66 patients being naive to ART treatment. The trial was funded by a global coalition of multinational and South African companies. VIR201 failed to elicit a statistically significant increase in immune response relative to the control group in both T-cell assay (Eli-spot) and assays of antibody isotype.
Zimbabwe could reduce the number of new adult HIV infections by over 80% in 2025 if the country scales up male circumcision (MC) services, a health official has said. HIV prevention coordinator, Aids/TB unit in the Ministry of Health and Child Welfare, Gertrude Ncube, revealed in a recent health report that increased MC would greatly reduce adult HIV infections.
"Between the period 2009 to 2015, the number of new infections will decline from 90 000 to 16 500 and the cumulative number of adult HIV infections averted could be almost 750 000, if more men go for male circumcision," she said. Ncube, however, said neonatal MC would not significantly reduce adult infections. "Male circumcision of neonatal or babies that have just been born will not contribute to the reduction of new infections, until those boys have grown up and become sexually active," she said.
The number of men undergoing circumcision continues to increase, with current figures standing at 6 500 since September last year. In Bulawayo, circumcision uptake as of February stood at 1 531, 63% of whom were aged between 15 and 29 while 36% were over 30 years. Since September last year the number of males circumcised in various age groups were as follows: 0-14 (3), 15-19 (193) 20-24 (156), 25-29 (381), 30-49 (422), 50 and above (16). This brought the total to 1 531 males that have been circumcised.
When the first female condoms were introduced in Uganda a few years ago, it came as good news to women. For them, it was an opportunity, for the first time, to be able to dictate condom use during sexual intercourse with their partners who sought unprotected sex. Unfortunately, the excitement was short-lived as that particular brand turned out to be a flop. The condoms were reportedly not user-friendly as they made lots of noise like a ruffling plastic bag would, while some women found it hard to insert and remove the rubber that they claimed looked like a surgeon's glove. With adjustments, however, it has been reported that the latest -- the new and improved -- version of these condoms is quite comfortable to use and should be of great help for women, as protection from sexually transmitted infections and unwanted pregnancies.
When Ms Ammina Kothari, a doctoral student at Indiana University, School of Journalism asked to interview me for her research paper on the HIV/Aids and journalism in Tanzania, I realised how poorly the media has been covering stories on the pandemic. Indeed, I felt guilty on behalf of my fellow journalists that we have not done the best we could do in that regard and consequently, the media has been left occasionally replicating the overused stories. In other words, the media lacked the angle with which to approach the issue.
The information journalists have been disseminating has been too skimpy, skimmed somewhere from say, journals and lack in in-depth analytical aspects that should be the guiding light to the society. Our writers do not take trouble to seek further empirical and statistical evidence and figures to support their reportage. Going through newspapers it seems they tell half-truths or report only what is presented to them by authorities that seek publicity.
Take for instance sometimes back when it was announced that male circumcision could reduce contraction of HIV by 60 per cent and thus it should be used as a tool for prevention of Aids. The media gave it little coverage if any. The issue of male circumcision should have been written in a way that would have explained the principles behind it and at the same time explain why people should not throw caution to the air and indulge in unprotected sex.
Following up a pioneering 2007 proof-of-concept study, a University of Utah biochemist and colleagues have developed a promising new anti-HIV drug candidate, PIE12-trimer, that prevents HIV from attacking human cells. Michael S. Kay, M.D., Ph.D., associate professor of biochemistry in the University of Utah School of Medicine and senior author of the study published on Aug. 18, 2010, online by the Journal of Virology, is raising funds to begin animal safety studies, followed by human clinical trials in two to three years. Kay believes PIE12-trimer is ideally suited for use as a vaginal microbicide (topically applied drug) to prevent HIV infection. His research group is particularly focused on preventing the spread of HIV in Africa, which has an estimated two-thirds of the world's 33 million HIV patients according to the World Health Organization.
To read the abstract published in the Journal of Virology on this study, see "Design of a potent D-peptide HIV-1 entry inhibitor with a strong barrier to resistance" by Welch et al in the "Published Research" section of this issue of the NewsDigest.
Starpharma Holdings Limited today announced the extension of the VivaGel(R) patent portfolio with the first grant of its patent specifically for the VivaGel(R) coated condom. The application will be granted on 20th August 2010 by the Russian patent office. Starpharma has also filed this patent in major markets including the USA, Canada, Europe, China, India and Japan. Both the VivaGel(R) coated condom and the VivaGel(R) standalone gel are already protected by a portfolio of granted VivaGel(R) patents in major markets. This new patent family not only provides additional protection for the condom product but also extends the duration of coverage in each market for which it is granted. In the case of this grant in Russia it provides coverage for the coated condom until at least 2026.
It is still unknown whether a noninfectious gammaherpesvirus vaccine is able to prevent or reduce virus persistence. This led us to use dendritic cells loaded with tumor B cells as a vaccine approach for the murine gammaherpesvirus 68 (gammaHV68) model of infection. Dendritic cells loaded with UV-irradiated latently infected tumor B cells induce broad, strong, and long-lasting immunity against gammaHV68. Dendritic cell vaccination prevents the enlargement of lymph nodes and severely limits acute infection and early latency but does not prevent gammaHV68 from establishing long-term latency. Our findings support the concept that attenuated viruses may be the best vaccine option for preventing gammaherpesvirus persistence.
Results of the CAPRISA 004 microbicide randomised trial1 recently electrified the AIDS 2010 Conference in Vienna, Austria. This groundbreaking safety and effectiveness study (funded by the US Agency for International Development [USAID]) showed that a vaginal gel containing 1% tenofovir significantly reduced a woman's risk of being infected with HIV or genital herpes. Tenofovir gel, used before and after sex, reduced the risk of HIV infection by 39% in the primary intent-to-treat analysis. The absolute difference in HIV-infection rates between the two groups was 3.5 infections per 100 women-years (5.6 vs 9.1 in the tenofovir and placebo groups, respectively). High adherence to the gel seemed to reduce the risk by 54% in an exploratory non-randomised comparison. Additionally, the pre/post gel regimen reduced the risk of HSV-2 infection by 51%.
Establishing proof of concept for a topical antiretroviral regimen, used intermittently, has thrown many in the HIV-prevention field into a spin. Some scientists had even questioned whether a topical microbicide would ever be effective in preventing HIV acquisition. Our belief structure was that the oral regimen, used daily, would have the greatest likelihood of demonstrating proof of concept. As a result, most of our prevention trials of pre-exposure prophylaxis with antiretrovirals were oriented toward this oral daily regimen (table). The theory was that the daily oral approach would produce better adherence and higher concentrations of drug in tissues, and thus it was the best first step. Only after success with the daily oral regimen, could the other approaches, such as intermittent topical and oral dosing, be evaluated for their relative effectiveness. However, CAPRISA 004 has leapfrogged this projected development timeline. We all need to go back to the drawing board.
Fortunately, the ongoing VOICE trial (MTN-003, funded by the US National Institutes of Health [NIH]) is examining the relative safety and effectiveness of the oral/topical antiretroviral regimens when used daily. VOICE is a five-group randomised phase 2b trial, comparing three oral groups (tenofovir, emtricitabine/tenofovir, and placebo) with two topical groups (tenofovir gel vs placebo gel). This trial is underway and has recruited about 25% of the 5000 participants anticipated. It will provide not only the essential evidence to support or challenge the CAPRISA 004 findings, but will also contribute to understanding the relative value of the oral versus topical regimens in preventing HIV acquisition in women.
The question of intermittent versus daily administration of a pre-exposure prophylactic antiretroviral is currently being addressed in three small head-to-head trials (IAVI E001, IAVI E002, HPTN 067). Other studies are evaluating the feasibility, pharmacokinetics, and behavioural aspects of intermittent oral therapies. But larger comparative studies of these different regimens need to begin soon.
CAPRISA 004 also challenges the HIV-prevention field to question its semantic silos. The current HIV-prevention terminology compartmentalises pre-exposure prophylaxis methods by mode of delivery. The term "microbicides" defines topical delivery, whereas the term "PrEP" defines oral delivery. These categories are outdated and inefficient. They spawn separate scientific meetings, publications, and discourse. Thus they limit a more integrated approach to combination prevention of HIV infection. Just as the VOICE trial is able to compare these two modes of delivery, similarly, the antiretrovirals for prevention field needs to consolidate its terminology.
In 2008, we had suggested a new lexicon to categorise HIV-prevention interventions. As we have seen with CAPRISA 004, use of antiretrovirals to prevent HIV transmission has become a broad field of its own, encompassing many overlapping scientific issues. As with hormonal contraception as a method to prevent unintended pregnancy, future evaluations of antiretroviral prophylaxis will focus on methods of delivery (oral, topical [vaginal, rectal], injectable), regimens (daily, monthly, intermittent/exposure related, pre and post), single versus combination products, and what works in specific target populations (defined by risk, behaviour, and infection status).
As a semantic starter, we might use the generic category "pre-exposure prophylaxis", and break it down by the mode of delivery: oral, topical, injectable, etc. Future scientific meetings would address these topics jointly. Collaboration has been the hallmark of shared information across the microbicide and PrEP fields. It is time now to unify the terminology and share information even more broadly.
CAPRISA 004 changes the model for HIV-prevention research. A WHO/UNAIDS meeting in South Africa in late August will examine the next steps for the many trials already underway, in addition to those on the drawing board. A careful, coordinated, and cooperative approach among the four main HIV-prevention research funders -- NIH, the US Agency for International Development, the Bill & Melinda Gates Foundation, and the UK Department for International Development -- is crucial to assure the research portfolio for HIV prevention will advance in the most efficient way. Proposed next steps involve investigations at multiple levels: molecular, clinical, and population. A new era indeed.
I am an FHI member of the CAPRISA 004 Trial Oversight Committee. FHI is one of the five CAPRISA 004 partners who provided support to the trial. FHI helped with study design, protocol development, behavioural intervention assessment, statistical and safety oversight, and clinical monitoring. My participation on the CAPRISA 004 team was funded by USAID grant #GHO-A-00-09-00016-00.
A large body of literature supports the notion that the language used in informed consent forms is not comprehensible to most research participants. Creating comprehensible informed consent forms for international research presents a further challenge because they are generally written first in English and then translated into the local language. The Kenya Medical Research National Ethical Review Committee determines readability of English consent forms before translation; however, it is neither their policy nor practice to determine whether the forms, once translated into Kiswahili, are of comparable readability to the English forms. Thus, the aim of this study is to measure and compare the text difficulty in 10 pairs of English informed consent forms and their translated Kiswahili forms. The results show that a readable English-language consent form does not necessarily result in a readable form once translated into Kiswahili.
The objective of this study -- a substudy to a phase I bioequivalence study -- was to compare the effect of standard and concise consent forms on research volunteers' comprehension of and satisfaction with consent forms, as well as to assess the effect of select volunteer characteristics, such as financial motivations to participate in research, on their comprehension. A 36-item questionnaire measured volunteers' comprehension, satisfaction, and motivations for participation. Volunteers were randomized to the standard Pfizer consent form or a concise, easier-to-read form. We approached 139 volunteers to participate, and 138 completed the questionnaire (response rate 99.3%). The cohorts did not differ in sociodemographic characteristics. We found that the average comprehension scores for the standard consent form cohort and the concise consent cohort were about the same, and that satisfaction with the consent form was high in both cohorts. Surprisingly, volunteers with a financial motivation had significantly greater comprehension of the study.
A major roadblock to the development of an effective vaccine against the human immunodeficiency virus (HIV-1) is the lack of an immunogen that elicits broadly protective antibodies. Passive transfer studies in animal models have associated protection with neutralizing antibodies and, encouragingly, serum studies show that a subset of HIV-infected individuals produces potent broadly neutralizing antibodies. Understanding the viral targets of such antibodies and how they achieve potent and broad neutralization has become a key endeavor in HIV vaccine research. On page 856 of this issue, Wu et al. describe the isolation of particularly potent monoclonal broadly neutralizing antibodies using a novel selection strategy, and on page 811, Zhou et al. solve the crystal structure of the most effective of these antibodies in complex with its target gp120, a viral envelope glycoprotein. These studies further invigorate the currently active field of discovering broadly neutralizing antibodies against HIV and provide valuable molecular information for rational vaccine design.
Developing a protective HIV vaccine remains a top global health priority. One strategy to identify potential vaccine candidates is to isolate broadly neutralizing antibodies from infected individuals and then attempt to elicit the same antibody response through vaccination (see the Perspective by Burton and Weiss below). Wu et al. (p. 856, published online 8 July) now report the identification of three broadly neutralizing antibodies, isolated from an HIV-1-infected individual, that exhibited great breadth and potency of neutralization and were specific for the co-receptor CD4-binding site of the glycoprotein 120 (gp120), part of the viral Env spike. Zhou et al. (p. 811, published online 8 July) analyzed the crystal structure for one of these antibodies, VRC01, in complex with an HIV-1 gp120. VRC01 focuses its binding onto a conformationally invariant domain that is the site of initial CD4 attachment, which allows the antibody to overcome the glycan and conformational masking that diminishes the neutralization potency of most CD4-binding-site antibodies. The epitopes recognized by these antibodies suggest potential immunogens that can inform vaccine design.
To gauge the current commitment to scientific research in the United States of America (US), we compared federal research funding (FRF) with the US gross domestic product (GDP) and industry research spending during the past six decades. In order to address the recent globalization of scientific research, we also focused on four key indicators of research activities: research and development (R&D) funding, total science and engineering doctoral degrees, patents, and scientific publications. We compared these indicators across three major population and economic regions: the US, the European Union (EU) and the People's Republic of China (China) over the past decade. We discovered a number of interesting trends with direct relevance for science policy. The level of US FRF has varied between 0.2% and 0.6% of the GDP during the last six decades. Since the 1960s, the US FRF contribution has fallen from twice that of industrial research funding to roughly equal. Also, in the last two decades, the portion of the US government R&D spending devoted to research has increased. Although well below the US and the EU in overall funding, the current growth rate for R&D funding in China greatly exceeds that of both. Finally, the EU currently produces more science and engineering doctoral graduates and scientific publications than the US in absolute terms, but not per capita. This study's aim is to facilitate a serious discussion of key questions by the research community and federal policy makers. In particular, our results raise two questions with respect to: a) the increasing globalization of science: "What role is the US playing now, and what role will it play in the future of international science?"; and b) the ability to produce beneficial innovations for society: "How will the US continue to foster its strengths?"
Objective Life has changed dramatically for infants exposed perinatally to HIV to HIV primarily because of a successful translational research program that has also affected treatment costs. We compared treatment costs among HIV+ patients in an HIV/AIDS specialty clinic across 3 treatment eras: monotherapy (pre-1990), combination therapy (1990-1996), and highly active antiretroviral therapy (HAART) (1997-2007). We also estimated cumulative health care costs among pediatric HIV/AIDS patients born in each era.
Patients and Methods Data on health care use were collected from medical records of 126 infants born to HIV+ mothers during a 21-year period (1986-2007) (728 person-years). The Drug Topics Red Book 1999 was used for drug costs, the Current Procedural Terminology Medicare Fee Schedule codes for outpatient costs, and the Healthcare Cost and Utilization Project Kids' Inpatient Database for inpatient costs. Generalized estimating equations and bootstrapped ordinary least-squares models were used to determine 2007 costs, cumulative costs, and cost savings.
Results Lifetime cost savings with HAART were $6.7 to $23.3 million, depending on incidence. Average total costs per HIV+ person per month were $1306 ($318 for drugs, $896 for total medical) in the monotherapy era, $2289 ($891 for drugs, $1180 for total medical) in the combination-therapy era, and $1814 ($1241 for drugs, $320 for total medical) in the HAART era. Total costs during the HAART era were 25.2% lower than costs during the combination-therapy era, because the 34% higher HAART drug costs were compensated for by total medical costs (inpatient + outpatient) that were 57% lower, which was a significant change (P < .001). The cumulative costs for treatment of an HIV+ patient were highest during the monotherapy era ($196 860) and lowest during the HAART era ($181 436).
Conclusions Our results show that the cost burden for the treatment of HIV+ pediatric patients has decreased over time. This historical examination of treatment-era costs demonstrates the value of technologic advances in treatment.
A small percentage of HIV-infected individuals, termed elite controllers, are able to spontaneously control HIV replication in blood. As the gastrointestinal mucosa is an important site of HIV transmission and replication, as well as CD4+ T-cell depletion, it is important to understand the nature of the immune responses occurring in this compartment. Although the role of the HIV-specific CD8+ T-cell responses in mucosal tissues has been described, few studies have investigated the role of mucosal HIV-specific CD4+ T-cells. In this study, we assessed HIV-specific CD4+ T-cell responses in the rectal mucosa of 28 "controllers" (VL<2,000 copies/mL), 14 "non-controllers" (VL<10,000 copies/mL), and 10 individuals on HAART (VL<50 copies/mL). Controllers had higher magnitude Gag-specific mucosal CD4+ T-cell responses than individuals on HAART (p<0.05), as measured by their ability to produce IFN[gamma], IL-2, TNF[alpha], and MIP-1[beta]. The frequency of polyfunctional mucosal CD4+ T-cells was also higher in controllers compared to non-controllers or individuals on HAART (p<0.05). Controllers with the strongest HIV-specific CD4+ T-cell responses possessed class II HLA alleles, HLA-DR*13 and/or HLA-DQ*06, previously associated with a non-progression phenotype. Strikingly, individuals with both HLA-DR*13 and HLA-DQ*06 had highly polyfunctional mucosal CD4+ T-cells compared to individuals with HLA-DQ*06 alone or other class II alleles. The frequency of polyfunctional CD4+ T-cells in rectal mucosa positively correlated with the magnitude of the mucosal CD8+ T-cell response (Spearman r=0.43, p=0.005), suggesting that increased CD4+ T-cell "help" may be important in maintaining strong CD8+ T-cell responses in the gut of HIV controllers.
High-risk cohorts in East Africa and the United States show rates of dual HIV-1 infection -- the concomitant or sequential infection by two HIV-1 strains -- of 50% to 100% of those of primary infection, and our normal-risk HIV-positive cohort in Cameroon exhibits a rate of dual infection of 11% per year, signifying that these infections are not exceptional. Little is known regarding the effect of dual infections on host immunity, despite the fact that they provide unique opportunities to investigate how the immune response is affected when challenged with diverse HIV-1 antigens. Using heterologous primary isolates, we have shown here that dual HIV-1 infection by genetically distant strains correlates with significantly increased potency and breadth of the anti-HIV-1 neutralizing antibody response. When the neutralization capacities of sequential plasma obtained before and after the dual infection of 4 subjects were compared to those of matched plasma obtained from 23 singly infected control subjects, a significant increase in the neutralization capacity of the sequential sample was found for 16/28 dually infected plasma/virus pairs, while only 4/159 such combinations for the control subjects exhibited a significant increase (P < 0.0001). Similarly, there was a significant increase in the plasma dilution capable of neutralizing 50% of virus (IC50) for 18/24 dually infected plasma/virus pairs, while 0/36 controls exhibited such an increase (P < 0.0001). These results demonstrate that dual HIV-1 infection broadens and strengthens the anti-HIV-1 immune response, suggesting that vaccination schemes that include polyvalent, genetically divergent immunogens may generate highly protective immunity against any HIV-1 challenge strain.
Most women contract HIV-1 through sexual intercourse with an infected partner. Highly prevalent, unreported and often asymptomatic lower genital tract infections, including bacterial vaginosis (BV) and trichomoniasis (Trichomonas vaginalis-TV), increase a woman's susceptibility to HIV-1 genital infection, given an exposure. A review of the literature from 1989 to the present was conducted. This article will review potential mechanisms by which BV and TV serve as HIV-1-enhancing cofactors including (i) initiation of a clinical or subclinical mucosal inflammatory response, (ii) alteration of innate mucosal immunity, (iii) alteration of normal vaginal microflora and pH, and (iv) weakening or breach of intact cervico-vaginal mucosa. The transmission of HIV-1, in the absence of cofactors, is poorly efficient. Understanding the mechanisms by which these infections enhance HIV-1 acquisition is important to designing effective, safe and evidence-based prevention modalities.
The HIV gp41 N-trimer "pocket" region is an ideal viral target because it is extracellular, highly conserved, and essential for viral entry. Here, we report the design of a pocket-specific D-peptide, PIE12-trimer that is extraordinarily elusive to resistance and characterize its inhibitory and structural properties. D-peptides (peptides composed of D-amino acids) are promising therapeutic agents due to their insensitivity to protease degradation. PIE12-trimer was designed using structure-guided mirror-image phage display and linker optimization and is the first D-peptide HIV entry inhibitor with the breadth and potency required for clinical use. PIE12-trimer has ultra-high affinity for the gp41 pocket, providing it with a reserve of binding energy ("resistance capacitor") that yields a dramatically improved resistance profile compared to other fusion inhibitors. These results demonstrate that the gp41 pocket is an ideal drug target and establish PIE12-trimer as a leading HIV antiviral candidate.
Research on the prevention of human immunodeficiency virus (HIV)-1 infection is at a critical juncture. Major methodological challenges to performing prevention trials have emerged, and one after another promising biomedical interventions have failed to reduce the incidence of HIV-1 infection. Nevertheless, there is growing optimism that progress can be achieved in the near term. Mathematical modeling indicates that 2 new strategies, "test and treat" and preexposure prophylaxis, could have a major impact on the incidence of HIV-1 infection. Will our hopes be justified? We review the potential strengths and limitations of these antiretroviral "treatment as prevention" strategies and outline other new options for reducing the incidence of HIV-1 infection in the near term. By maximizing the potential of existing interventions, developing other effective strategies, and combining them in an optimal manner, we have the opportunity to bring the HIV-1 epidemic under control.
Although circumcision reduces male acquisition of human immunodeficiency virus type-1 (HIV-1) by 60%, the initial mechanisms of HIV-1 transmission at the foreskin remain elusive. We have established two novel and complementary models of the human adult foreskin epithelium, namely, ex vivo foreskin explants and in vitro reconstructed immunocompetent foreskins. In these models, efficient HIV-1 transmission occurs after 1 h of polarized exposure of the inner, but not outer, foreskin to mononuclear cells highly infected with HIV-1, but not to cell-free virus. HIV-1-infected cells form viral synapses with apical foreskin keratinocytes, leading to polarized budding of HIV-1, which is rapidly internalized by Langerhans cells (LCs) in the inner foreskin. In turn, LCs migrate toward the epidermis-dermis interface to form conjugates with T cells, thereby transferring HIV-1. Seminal plasma mixed with cervicovaginal secretions inhibits HIV-1 translocation. This set of results rationalizes at the cellular level the apparent protective outcome of circumcision against HIV-1 acquisition by men.
Background Previous clinical efficacy trials failed to support the continued development of recombinant gp120 (rgp120) as a candidate HIV vaccine. However, the recent RV144 HIV vaccine trial in Thailand showed that a prime/boost immunization strategy involving priming with canarypox vCP1521 followed by boosting with rgp120 could provide significant, although modest, protection from HIV infection. Based on these results, there is renewed interest in the development of rgp120 based antigens for follow up vaccine trials, where this immunization approach can be applied to other cohorts at high risk for HIV infection. Of particular interest are cohorts in Africa, India, and China that are infected with clade C viruses.
Methodology/Principal Findings A panel of 10 clade C rgp120 envelope proteins was expressed in 293 cells, purified by immunoaffinity chromatography, and used to immunize guinea pigs. The resulting sera were collected and analyzed in checkerboard experiments for rgp120 binding, V3 peptide binding, and CD4 blocking activity. Virus neutralization studies were carried out with two different assays and two different panels of clade C viruses. A high degree of cross reactivity against clade C and clade B viruses and viral proteins was observed. Most, but not all of the immunogens tested elicited antibodies that neutralized tier 1 clade B viruses, and some sera neutralized multiple clade C viruses. Immunization with rgp120 from the CN97001 strain of HIV appeared to elicit higher cross neutralizing antibody titers than the other antigens tested.
Conclusions/Significance While all of the clade C antigens tested were immunogenic, some were more effective than others in eliciting virus neutralizing antibodies. Neutralization titers did not correlate with rgp120 binding, V3 peptide binding, or CD4 blocking activity. CN97001 rgp120 elicited the highest level of neutralizing antibodies, and should be considered for further HIV vaccine development studies.
Background This study was undertaken to establish the etiology of the male urethral discharge (MUDS) and vaginal discharge (VDS) syndromes, to determine the prevalence of other sexually transmitted infections (STI) and human immunodeficiency virus (HIV) coinfections, and to examine associations between STIs and HIV serostatus among STI patients in South Africa.
Methods A total of 507 MUDS and 300 VDS patients were recruited in Cape Town (CPT) and Johannesburg (JHB). A multiplex polymerase chain reaction assay detected Neisseria gonorrhoeae, Chlamydia trachomatis, Trichomonas vaginalis, and Mycoplasma genitalium infections. Bacterial vaginosis and candidiasis were detected by microscopy. Sera were screened for syphilis, HSV-2, and HIV antibodies.
Results Etiological diagnoses were made for 92% of MUDS patients and 85% of VDS patients. Gonorrhoea accounted for 85% (CPT) and 71% (JHB) of MUDS presentations. Chlamydia was the second most frequently detected MUDS pathogen (CPT, 13%; JHB, 24%). Among VDS patients, bacterial vaginosis was the most common cause (CPT, 46%; JHB, 36%) and trichomoniasis the most frequently detected STI pathogen (CPT, 19%; JHB, 34%). Few patients (4%) had serological evidence of syphilis. The HSV-2 and HIV seroprevalence were higher in Johannesburg compared to Cape Town and among women compared to men. HIV infection was statistically significantly associated with HSV-2 seropositivity at both sites and with the presence of N. gonorrhoeae and absence of C. trachomatis in Cape Town MUDS patients.
Conclusions Gonorrhoea and bacterial vaginosis were confirmed as the most frequent causes of MUDS and VDS. The high HIV seroprevalence in STI patients emphasizes the need to address HIV testing among this population.
Background Colposcopy is widely used in clinical microbicide safety testing but not in preclinical small animal studies. Endoscopic colposcopy could be employed in small animals allowing colposcopy to be used as one component in a multifactorial safety testing paradigm.
Study Design We conducted dose-response studies in mice using 2%, 0.2%, or 0.02% benzalkonium chloride (BZK) as the test compound, and using multiple safety end points that included endoscopic colposcopy, susceptibility to vaginal HSV-2 infection, histology, and entry of inflammatory cells into the vagina.
Results Animals treated with 0.2% or higher BZK experienced vaginal toxicities detectable by all tests used including colposcopy. In contrast, 0.02% BZK produced no significant changes except by histology in which a significant thinning of the vaginal epithelium was seen.
Conclusion Endoscopic colposcopy detected microbicide-elicited changes in the mouse vagina with similar sensitivity to the other endpoints used in these studies and would appear to be useful as part of a multifactorial microbicide safety testing paradigm in mice.
Objectives To compare the situational characteristics of protected and unprotected sexual encounters that involved alcohol use 2 hours prior with ones that did not.
Methods Data were collected between December 2002 and December 2005 as part of enrollment in a prospective cohort study designed to identify HIV seroconversion risk factors among women bar and hotel workers in Northern Tanzania. A total of 608 (37.3%) of the women who were inconsistent condom users were asked a set-matched questions concerning situational characteristics surrounding their last protected and unprotected sexual encounter including whether they had been drinking within 2 hours of sex. The associations between drinking 2 hours before sex (yes/no), condom use (protected/unprotected), and their interaction with the situational descriptors were examined with a 2 x 2 model for paired categorical data after controlling for time since the last type of encounter.
Results Condom failure was 5 times more likely if someone (woman, man, or both partners) had been drinking in advance of the encounter (OR, 5.19; 95% CI, 2.05-15.46) and was especially likely to occur if only the woman had been drinking before sex (OR, 14.05; 95% CI, 4.03-50.41). Alcohol use before sex was associated with sexual contacts where the woman was having sex with her partner for the first time, their relationship was casual or transitory or sex was transactional, the location was unfamiliar and less under her control, and the partner had been drinking or using drugs before having sex. Condom use was more frequent in precisely the same types of encounters. Interestingly, there were no significant interactions between alcohol use before sex and condom use, suggesting that drinking before sex and use of condom are distinct and not contingent risk factors.
Conclusions Alcohol use before sex is associated with an increased likelihood of condom failures and with high-risk sexual encounters, ones that have consistent situational characteristics regardless of whether condoms are used or not.
Female sex workers who had prevalent chlamydial, gonococcal, or trichomonal infection at enrollment into a randomized trial in Madagascar were 2 to 4 times as likely to become infected during follow-up, compared to women without STIs at baseline, despite provision of condoms, safer sex counseling, and repeat STI testing and treatment.
Early bird registration deadline: November 30, 2010. Registration deadline: January 15, 2011.
Description: This symposium aims to provide updated information on HIV treatment and research for physicians and allied health professionals. An expert faculty of speakers from Thailand, the Asian region, the United States, Europe, and Australia will present a comprehensive review of current HIV management. The symposium also aims to stimulate debate through a series of panel discussions on issues such as access to care and the cost of ARV in developing countries.
Sponsor: HIV-NAT, The Netherlands, Australia, Thailand Research Collaboration.
Journalists Against AIDS (JAAIDS) Nigeria, on behalf of Partners of the Red Ribbon Awards, hereby invites entries for the 2010 edition of the Red Ribbon Awards on HIV/AIDS in Nigeria. The Red Ribbon Awards is an annual event instituted since 2001 to honour outstanding media response to the HIV and AIDS epidemics in Nigeria. Partners include the National Agency for the Control of AIDS (NACA), the United Nations System in Nigeria, National Network of People living with HIV/AIDS in Nigeria (NEPWHAN), the media and top players in Nigeria's private sector. The awards presentation will be held in Lagos in December 2010.
Award Categories A.Individual Effort:
Best Reporting on New HIV Prevention Technologies (Print): Supported by the New HIV Vaccines and Microbicides Advocacy Society (NHVMAS), this award seeks to promote informed media reporting on New HIV Prevention Technologies (NPTs). Acceptable entries in this category must cover issues related to biomedical HIV prevention research, development, and advances in fields focusing on Vaccines, Microbicides, Male Circumcision, Pre Exposure Prophylaxis (PReP) and other NPTs with particular emphasis on relevance to the local context, national policy, and promoting future access.
Best Feature Report (Print)
Best Television Feature
Best Radio Feature
Best HIV/AIDS Cartooning
Outstanding Informed Commentary (Print)
Best Local Language Reporting (Radio)
B. Corporate Category
Best Newspaper Editorial
C. Community Category
Breakers of Silence Award (Organization)
Breaker of Silence Award (Individual)
Special Recognition Award
Omololu Falobi Young Achiever's Award (Individual)
Awards & Prizes Prizes for recipients of Red Ribbon Awards include: cash prizes of N100, 000 and Red Ribbon plaques and certificates will be given to every winner; certificates of recognition and consolation prizes will be given to runners-up.
Competition Criteria Entries must have been published or broadcast between October 1, 2009 and September 30, 2010. Journalists can submit up to three (3) of their best stories, articles, reports or cartoons in each category to enter for any of the media categories. Each article must be submitted as an original copy. Clean photocopy in A3 size (for newspaper articles) or A4 (for magazine) allowed only in exceptional circumstances, with each entry clearly showing date and medium of publication. Low quality photocopies will automatically be rejected. For cartoons, original illustrations will not be accepted; only published cartoons with name of medium, date and page clearly visible will be accepted.
Broadcast entries must be submitted in VCD/CD format with date of broadcast, medium and duration clearly written on the label sleeve. VHS tapes, minidisk or audiocassettes will not be accepted. Entries with poor audio quality will automatically be disqualified. The entries must also be accompanied by a full transcript of the tapes.
Entrants can submit entries for a maximum of two (2) award categories, provided that separate entries are submitted for each category. All entries must be accompanied by a short bio and a covering letter signed by the entrant's supervisor. Entries must be received by Friday, October 15, 2010 and must be stories written about the Nigerian situation. Please note that foreign stories with little or no local relevance would not be accepted.
The Red Ribbon Awards is open to Nigerian journalists and organizations including freelancers working in Nigeria for media organizations that are Nigerian-owned or principally based in the country or published in Nigeria for Nigerians. An independent panel of judges with requisite knowledge and experience will review all entries and determine winners. Entries will be judged based on the quality of story, sound or voice, depth of coverage and relevance to local situation. Entries must also reflect appropriate use of language and an inclusion of a focus on people living with HIV/AIDS. Please note that entries in the Community Category are by nominations only.
All entries and nominations should be submitted to the Red Ribbon Awards Secretariat either in Lagos or Abuja: Lagos Journalists Against AIDS (JAAIDS) Nigeria Media Resource Centre on HIV/AIDS and Reproductive Health, 14 Fadare Street, end of Kayode Street, Ogba, Lagos. Tel: 234 1 7731457, 8128565 Abuja Journalists Against AIDS (JAAIDS) Nigeria 4 Jaba Close, off Dunukofia Street, Area 11, Garki, Abuja. Tel: 09-6721744 firstname.lastname@example.org
The Developing Countries Coordination Committee (DCCC) of the European and Developing Countries Clinical Trials Partnership (EDCTP) is seeking four new members to replace those who have completed their tenure. Applications are invited from senior scientific experts and health professionals from sub-Saharan Africa with experience in HIV/AIDS, malaria or tuberculosis in the following areas:
HIV/AIDS (1 position for Southern African region)
TB (1 position for each of the following sub-Saharan Africa regions: Eastern Africa, Central Africa and Southern African).
Provide strategic technical and scientific inputs on the EDCTP programme strategy
Identify gaps and monitor progress in health capacity development in Africa
Develop strategies and actions to improve coordination between its members and with other partners
Advocate and promote the visibility and impact of the EDCTP and African health research community in general
Develop and implement strategies to develop African commitment, ownership and leadership of the EDCTP and international health research programmes in Africa
Facilitate networking strategies of EDCTP
Work closely with other EDCTP constituencies and Secretariat.
The deadline for application is 20 October 2010. The position starting date is 1 January 2011. Members shall be appointed for a period of two years. For more details please consult the full vacancy text on the EDCTP website.
November 17-19 2010 Gaylord National Hotel, National Harbor, MD
The Scientific Planning Committee for the 2010 National Summit on HIV Diagnosis, Prevention and Access to Care is issuing a Call for Abstracts for presentations at the upcoming National Summit conference. Visit the 2010 HIV Summit Abstract Submission Website for more information.
Reproductive Health 2010 is the top conference for staying current with the latest research and learning to apply these advances to your practice. In addition to cutting-edge research from 123 oral and poster abstracts, Reproductive Health 2010 offers a comprehensive agenda full of compelling sessions presented by leading experts in our field. Reproductive Health 2010 will be held September 22-25 at the Hyatt Regency Atlanta.
The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER), Small Business Assistance, is announcing a public workshop on the Investigational New Drug (IND) Process. The Investigational New Drug (IND) application process is a crucial step in the drug development and approval process. The objective of this workshop is to clarify and explore fundamental aspects of the IND. Highlights include: drug development timeline; phases of an IND; types of meetings with FDA; clinical development of rare diseases; examples of recent rare disease programs; rare disease help and information at FDA; goals of inspections: Clinical Investigator Program; selecting clinical investigators for audit; FDA expectations of clinical investigators; inspectional procedures/DSI actions
The meeting will be held on October 8, 2010, beginning at 9:15 a.m., at the following location: National Labor College (NLC) George Meany Campus 10,000 New Hampshire Ave., Silver Spring, Maryland 20903 (301) 431-6400
Space is limited to 150 participants. We appreciate advance notice of cancellations or replacements. Registrants will receive confirmation once they have been accepted. Onsite registration on the day of the public meeting will be provided on a space-available basis beginning at 8:45am. Online registration is available. Registration will close on Thursday, September 30, 2010. The meeting will not be videotaped or webcast.
If you need special accommodations due to a disability, please contact Brenda Stodart at 301-796-3400, at CDERSmallBusiness@fda.hhs.gov at least 7 days in advance of the meeting. For further information about this meeting, contact: Brenda Stodart; 301-796-3400; e-mail: CDERSmallBusiness@fda.hhs.gov.
The European and Developing Countries Clinical Trials Partnership (EDCTP) welcomes project proposals as a response to the following calls:
Member States Initiated projects on HIV/AIDS, TB and malaria Available funds: Euro 2.5 million Open to application: 16 August 2010 Deadline of application: 13 December 2010
Purpose of the grant European Member States often independently fund projects that fall within the remit of EDCTP (clinical trials, capacity building and networking on HIV/AIDS, TB and malaria in sub-Saharan Africa). The purpose of this grant is for EDCTP to provide funding and added value to these initiatives by acting as the locus of integration for various projects and programmes that have been independently initiated and/or funded by member states.
Evaluating the impact of clinical trials in Africa Available funds: = Euro 850,000 Open to application: 16 August 2010 Deadline of application: 15 November 2010
Purpose of the grant There is anecdotal information that clinical trials may negatively impact routine healthcare delivery by diverting resources. Contrary reports, however, have indicated that clinical trials contribute to the quality of routine healthcare, for example, by providing training and improved infrastructure. This grant therefore, is aimed at gaining comprehensive insight into the impact of clinical trials on health services in sub-Saharan Africa, especially with regard to the quality of those services delivered to women and/or children. Emphasis should be placed on evaluating the impact from the perspective of patients; health professionals; the community; and, public health services at the sites in sub-Saharan Africa, where the clinical trials are being conducted. The project should be designed so that the outcome could contribute to the development of methods to further embed clinical research within the health services. This is important since it is the health services that that would eventually be responsible for implementing the (new) interventions resulting from the clinical trials. This call offers consortia senior public health/social science researchers from Europe and sub-Saharan Africa the opportunity to apply for a 1-2 year research grant to investigate the impact of EDCTP and non-EDCTP funded clinical trials in sub-Saharan Africa.
NIH funding was awarded to Strata Various Product Design on July 1, 2010, for an 18 mo, Phase 1 Feasibility & Acceptability Study of a new female condom concept, the ORIGAMI Female Condom. This grant will help to develop the device, conduct preclinical testing, conduct a User Preference Study and a Couples Acceptability & Performance Study.
The new condom concept is intended to be more attractive and pleasurable for both partners. The manufacturer says "The Origami Female Condom has a 'no-fumble' method of insertion that is quicker and easier to use than existing commercially available product."
The 2011 BIO International Convention Call for Session Proposals officially opens Sept. 1 and will close on Sept. 22! BIO will host 125-plus breakout sessions along 15 educational tracks in Washington, D.C., and we encourage you to share your extensive knowledge by becoming a speaker today. BIO welcomes session proposals from biotechnology industry experts, policy leaders, analysts, academics and other thought leaders. The program covers a wide variety of relevant topics, including health care, the environment, food and agriculture, industrial and other areas that are pertinent to the biotechnology industry. Learn more about submitting a session proposal.