CAPRISA 004
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CAPRISA 004
CAPRISA 004 is the name of a clinical trial conducted by CAPRISA. This particular study was the first to show that a topical gel could reduce a person's risk of contracting HIV. The gel used in the study contained a microbicide. Background A previous study had measured the safety and tolerability of tenofovir in both sexually active and abstinent women. This study gave support to the idea that tenofovir was a drug which was worth examining as an HIV preventative. Study design CAPRISA 004 was a phase IIb, double-blind, randomized, placebo-controlled study comparing 1% tenofovir gel with a placebo gel. 900 young women who were judged to be at risk of contracting HIV volunteered to use a study gel in their vaginas, with half of those receiving the microbicide gel and the other half getting the placebo (according to their randomization results). The study asked participants to apply a first dose of the gel within 12 hours before having sex and to apply another dose within 12 hours ...
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CAPRISA
CAPRISA ("Centre for the AIDS Programme of Research in South Africa") is the name of an AIDS research center based in Durban, South Africa. History CAPRISA was established in 2002 under the National Institutes of Health program called Comprehensive International Program of Research on AIDS (CIPRA). Five partner institutions participated in the founding: University of KwaZulu-Natal, University of Cape Town, University of Western Cape, National Institute of Communicable Diseases, and Columbia University in New York. UNAIDS recognizes CAPRISA with the designation of "Collaborating Centre for HIV Prevention Research." CAPRISA's mission is to promote HIV prevention and research its epidemiology. CAPRISA 004 CAPRISA 004 is the name of a clinical trial testing a microbicide An antimicrobial is an agent that kills microorganisms or stops their growth. Antimicrobial medicines can be grouped according to the microorganisms they act primarily against. For example, antibiotics are use ...
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Voice Of America
Voice of America (VOA or VoA) is the state-owned news network and international radio broadcaster of the United States of America. It is the largest and oldest U.S.-funded international broadcaster. VOA produces digital, TV, and radio content in 48 languages which it distributes to affiliate stations around the globe. It is primarily viewed by a non-American audience. VOA was established in 1942, and the VOA charter (Public Laws 94-350 and 103–415) was signed into law in 1976 by President Gerald Ford. VOA is headquartered in Washington, D.C., and overseen by the U.S. Agency for Global Media (USAGM), an independent agency of the U.S. government. Funds are appropriated annually under the budget for embassies and consulates. In 2016, VOA broadcast an estimated 1,800 hours of radio and TV programming each week to approximately 236.6 million people worldwide with about 1,050 employees and a taxpayer-funded annual budget of . While Voice of America is seen by some foreign list ...
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Clinical Study Design
Clinical study design is the formulation of trials and experiments, as well as observational studies in medical, clinical and other types of research (e.g., epidemiological) involving human beings. The goal of a clinical study is to assess the safety, efficacy, and / or the mechanism of action of an investigational medicinal product (IMP) or procedure, or new drug or device that is in development, but potentially not yet approved by a health authority (e.g. Food and Drug Administration). It can also be to investigate a drug, device or procedure that has already been approved but is still in need of further investigation, typically with respect to long-term effects or cost-effectiveness. Some of the considerations here are shared under the more general topic of design of experiments but there can be others, in particular related to patient confidentiality and ethics. Outline of types of designs for clinical studies Treatment studies * Randomized controlled trial ** Blind trial ** ...
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Monitoring In Clinical Trials
Clinical monitoring is the oversight and administrative efforts that monitor a participant's health and efficacy of the treatment during a clinical trial. Both independent and government-run grant-funding agencies, such as the National Institutes of Health (NIH) and the World Health Organization (WHO), require data and safety monitoring protocols for Phase I and II clinical trials conforming to their standards. Safety monitoring Safety monitoring of a clinical trial is conducted by an independent physician with relevant expertise. This is accomplished by review of adverse event, immediately after they occur, with timely follow-up through resolution. Responsibility for data and safety monitoring depends on the phase of the study and may be conducted by sponsor or Contract research organization (CRO) staff or contractor, and/or by the Principal clinical investigator/project manager conducting the study. Regardless of the method used, monitoring must be performed on a regular basis. ...
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Clinical Trial Protocol
In natural and social science research, a protocol is most commonly a predefined procedural method in the design and implementation of an experiment. Protocols are written whenever it is desirable to standardize a laboratory method to ensure successful replication of results by others in the same laboratory or by other laboratories. Additionally, and by extension, protocols have the advantage of facilitating the assessment of experimental results through peer review. In addition to detailed procedures, equipment, and instruments, protocols will also contain study objectives, reasoning for experimental design, reasoning for chosen sample sizes, safety precautions, and how results were calculated and reported, including statistical analysis and any rules for predefining and documenting excluded data to avoid bias. Similarly, a protocol may refer to the procedural methods of health organizations, commercial laboratories, manufacturing plants, etc. to ensure their activities (e.g., b ...
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Family Health International
FHI 360 (formerly Family Health International) is a nonprofit human development organization based in North Carolina. FHI 360 operates in more than 70 countries and all U.S. states and territories. Established in 1971, the organization manages projects relating to family planning and reproductive health. In 1986 the organization began a worldwide response to HIV/AIDS. FHI 360's research and programs also address malaria, tuberculosis, and other infectious and chronic diseases and international agencies, governments, foundations, research institutions, and individual donors. __TOC__ History Other major sponsors of HIV/AIDS programs, as well as other health and development areas, include the United Kingdom's Department for International Development (DFID), the Bill and Melinda Gates Foundation and the Global Fund to Fight AIDS, Tuberculosis and Malaria. Other governments, private foundations, and the private sector have partnered with FHI 360 to overcome health and development ch ...
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Gilead Sciences
Gilead Sciences, Inc. () is an American biopharmaceutical company headquartered in Foster City, California, that focuses on researching and developing antiviral drugs used in the treatment of HIV/AIDS, hepatitis B, hepatitis C, influenza, and COVID-19, including ledipasvir/sofosbuvir and sofosbuvir. Gilead is a member of the NASDAQ Biotechnology Index and the S&P 500. Gilead was founded in 1987 under the name Oligogen by Michael L. Riordan. The original name was a reference to oligomers, small strands of DNA used to target genetic sequences. Gilead held its IPO in 1992, and successfully developed drugs like Tamiflu and Vistide that decade. In the 2000s, Gilead received approval for drugs including Viread and Hepsera, among others. It began evolving from a biotechnology company into a pharmaceutical company, acquiring several subsidiaries, though it still relied heavily on contracting to manufacture its drugs. The company continued its growth in the 2010s, but came under heavy ...
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Technology Innovation Agency
The Technology Innovation Agency was created by an act of the South African parliament The Parliament of the Republic of South Africa is South Africa's legislature; under the present Constitution of South Africa, the bicameral Parliament comprises a National Assembly and a National Council of Provinces. The current twenty-seve ... on 24 November 2008. TIA is an initiative of the Department of Science & Technology (DST) that came into existence through the promulgation of the Technology Innovation Agency Act No.26 of 2008. TIA’s mandate is to enable and support technological innovation across all sectors of the economy in order to achieve socio-economic benefits for South Africa and enhance its global competitiveness. This entails supporting the development and commercialisation of research outputs from Higher Education Institutions, Science Councils, Public Entities, and private research institutions and bringing them to market. Latest News TIA's CEO, Simphiwe Duma, and ...
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United States Agency For International Development
The United States Agency for International Development (USAID) is an independent agency of the U.S. federal government that is primarily responsible for administering civilian foreign aid and development assistance. With a budget of over $27 billion, USAID is one of the largest official aid agencies in the world and accounts for more than half of all U.S. foreign assistance—the highest in the world in absolute dollar terms. Congress passed the Foreign Assistance Act on September 4, 1961, which reorganized U.S. foreign assistance programs and mandated the creation of an agency to administer economic aid. USAID was subsequently established by the executive order of President John F. Kennedy, who sought to unite several existing foreign assistance organizations and programs under one agency. USAID became the first U.S. foreign assistance organization whose primary focus was long-term socioeconomic development. USAID's programs are authorized by Congress in the Foreign Assistanc ...
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AIDS Vaccine Advocacy Coalition
AVAC is a New York City-based international non-profit community- and consumer-based organization working to accelerate ethical development and delivery of AIDS vaccines and other HIV prevention options to populations throughout the world. Founded in 1995, AVAC uses public education, policy analysis, advocacy and Community Mobilization to accelerate a comprehensive response to the epidemic. Communication Strategies: AVAC's goal is to involve affected populations in work to promote the ethical introduction and distribution of life-saving HIV/AIDS technologies such as vaccines and microbicides. AVAC works to provide independent analysis, policy advocacy, public education and mobilisation to enhance AIDS vaccine research and development. A key channel for these efforts is the AVAC website, which is designed to support a network of individuals by sharing research, policy alerts, and strategies for action. Various links and resources designed to inform and engage vaccine advocates are ...
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NIAID
The National Institute of Allergy and Infectious Diseases (NIAID, ) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases. NIAID has on-campus laboratories in Maryland and Hamilton, Montana, and funds research conducted by scientists at institutions in the United States and throughout the world. NIAID also works closely with partners in academia, industry, government, and non-governmental organizations in multifaceted and multidisciplinary efforts to address emerging health challenges such as the H1N1/09 pandemic and the COVID-19 pandemic. History NIAID traces its origins to a small laboratory established in 1887 at the Marine Hospital on Staten Island, New York (now the Bayley Seton Hospital). Officials of the Marin ...
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Anthony Fauci
Anthony Stephen Fauci (; born December 24, 1940) is an American physician-scientist and immunologist serving as the director of the National Institute of Allergy and Infectious Diseases (NIAID) and the chief medical advisor to the president. As a physician with the National Institutes of Health (NIH), Fauci has served the American public health sector in various capacities for more than fifty years and has acted as an advisor to every U.S. president since Ronald Reagan. He has been director of the NIAID since 1984 and has made contributions to HIV/AIDS research and other immunodeficiency diseases, both as a research scientist and as the head of the NIAID. From 1983 to 2002, Fauci was one of the world's most frequently cited scientists across all scientific journals. In 2008, President George W. Bush awarded him the Presidential Medal of Freedom, the highest civilian award in the United States, for his work on the AIDS relief program PEPFAR. During the COVID-19 pandemic, h ...
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