 | This article needs to be updated.(April 2017) |
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.
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. [1]
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 after sex. All study volunteers participated in HIV risk reduction counseling and received condoms. The study assisted in arranging treatment for any sexually transmitted infections that participants contracted. [2]
The study began in May 2007, was completed in December 2009, and the data collected was published in March 2010. The study design had expected the study to last for 30 months, with about 14 months to recruit study volunteers then with follow-up until 92 participants were observed to have become infected with HIV. The entrance criteria were such that, based on risk factors in the participants' lifestyles, the study expected 92 infections to occur approximately 16 months after they recruited the final volunteer. [2]
Researchers led by Quarraisha Karim found that a microbicide containing 1% tenofovir was, for women participating in the trial, 39% effective in reducing risk of contracting HIV during sex and 51% effective in preventing genital herpes infections. [3] [4]
The results of CAPRISA 004 were formally released at the 18th International AIDS Conference. [5]
Michel Sidibé of UNAIDS described the results of the study as being very encouraging because the treatment "can be controlled by women, and put in 12 hours earlier, and that is empowering. They do not have to ask the man for permission to use it. And the cost of the gel is not high." [6]
Anthony Fauci of NIAID stated that "This is the first study that has shown a clear-cut positive effect of a microbicide on blocking acquisition of HIV infection." [7]
Mitchell Warren, head of the AIDS Vaccine Advocacy Coalition, remarked that "This is a really historic day for HIV prevention research. For the first time, through the CAPRISA 004 trial, we have seen evidence in a human clinical trial that a microbicide can help to prevent sexual transmission." [5]
A Phase III study named "FACTS 001", a larger study involving 2,200 women in Africa which is expected to start around the end of July 2011 and last 24 months. [8]
CAPRISA conducted CAPRISA 004 with the following assistance:
The principal investigators for the study were Salim Abdool Karim and Quarraisha Abdool Karim, both of the University of KwaZulu-Natal. The study was conducted at the eThekwini Clinical Research Site in Durban, South Africa and the Vulindlela Clinical Research Site in Pietermaritzburg, South Africa. [2]
Microbicides for sexually transmitted infections are pharmacologic agents and chemical substances that are capable of killing or destroying certain microorganisms that commonly cause sexually transmitted infection.
FHI 360 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.
Emtricitabine/tenofovir, sold under the brand name Truvada among others, is a fixed-dose combination antiretroviral medication used to treat and prevent HIV/AIDS. It contains the antiretroviral medications emtricitabine and tenofovir disoproxil. For treatment, it must be used in combination with other antiretroviral medications. For prevention before exposure, in those who are at high risk, it is recommended along with safer sex practices. It does not cure HIV/AIDS. Emtricitabine/tenofovir is taken by mouth.
Pre-exposure prophylaxis for HIV prevention, commonly known as PrEP, is a form of pre-exposure prophylaxis to prevent HIV infection, the cause of HIV/AIDS.
The HIV Prevention Trials Network (HPTN) is a worldwide collaborative clinical trials network that brings together investigators, ethicists, community and other partners to develop and test the safety and efficacy of interventions designed to prevent the acquisition and transmission of HIV. HPTN studies evaluate new HIV prevention interventions and strategies in populations and geographical regions that bear a disproportionate burden of infection. The HPTN is committed to the highest ethical standards for its clinical trials and recognizes the importance of community engagement in all phases of the research process.
iPrEx was a phase III clinical trial to determine whether the antiretroviral medication emtricitabine/tenofovir could safely and effectively prevent HIV acquisition through sex in men who have sex with men and transgender women. iPrEx was the first human study of an HIV prevention strategy known as pre-exposure prophylaxis, or PrEP.
CAPRISA is the name of an AIDS research center based in Durban, South Africa.
Zeda Fran Rosenberg is an American microbiologist and epidemiologist, active in HIV biology and prevention. She is the chief executive officer of the International Partnership for Microbicides (IPM). IPM was founded by Rosenberg in 2002 and is a nonprofit organization dedicated to developing microbicides and other innovative HIV prevention products and making them available for women in developing countries.
CONRAD is a non-profit organization scientific research organization that works to improve the reproductive health of women, especially in developing countries. CONRAD was established in 1986 under a cooperative agreement between Eastern Virginia Medical School (EVMS) and the United States Agency for International Development(USAID). CONRAD’s products are developed primarily for women in low-resource settings, in that they are designed to be safe, affordable and user-friendly. CONRAD is led by Scientific and Executive Director Gustavo Doncel, M.D., Ph.D. Primary funding for CONRAD comes from the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) through the U.S. Agency for International Development (USAID), with additional funding from The Bill & Melinda Gates Foundation and the National Institutes of Health (NIH).
HIV prevention refers to practices that aim to prevent the spread of the human immunodeficiency virus (HIV). HIV prevention practices may be undertaken by individuals to protect their own health and the health of those in their community, or may be instituted by governments and community-based organizations as public health policies.
The STEP Study was a Phase IIb clinical trial intended to study the efficacy of an experimental HIV vaccine based on a human adenovirus 5 (HAdV-5) vector. The study was conducted in North and South America, the Caribbean, and Australia. A related study using the same experimental vaccine was conducted simultaneously in South Africa. These trials were co-sponsored by Merck, the HIV Vaccine Trials Network (HVTN), and the National Institute of Allergy and Infectious Diseases (NIAID), and had an Oversight Committee consisting of representatives from these three organizations. In South Africa the trial was overseen by the South African AIDS Vaccine Initiative.
A rectal microbicide is a microbicide for rectal use. Most commonly such a product would be a topical gel inserted into the anus so that it make act as protection against the contract of a sexually transmitted infection during anal sex.
PRO 2000 is an experimental vaginal microbicide which has been proposed as a preventive medicine for reducing the risk of contracting HIV. It has never been recommended as an effective medicine to be used for any purpose. Some clinical trials have shown that under some conditions it may provide some protection against HIV.
A vaginal microbicide is a microbicide for vaginal use, generally as protection against the contraction of a sexually transmitted infection during vaginal sexual intercourse. Vaginal microbicides are topical gels or creams inserted into the vagina.
Quarraisha Abdool Karim is an infectious diseases epidemiologist and co-founder and Associate Scientific Director of CAPRISA. She is a Professor in Clinical Epidemiology, Columbia University, New York and Pro-Vice Chancellor for African Health, University of KwaZulu-Natal, South Africa.
Salim S. Abdool Karim, MBChB, MMed, MS(Epi), FFPHM, FFPath (Virol), DipData, PhD, DSc(hc), FRS is a South African public health physician, epidemiologist and virologist who has played a leading role in the AIDS and COVID-19 pandemic. His scientific contributions have impacted the landscape of HIV prevention and treatment, saving thousands of lives.
Dan Hung Barouch is an American physician, immunologist, and virologist. He is known for his work on the pathogenesis and immunology of viral infections and the development of vaccine strategies for global infectious diseases.
Dapivirine (DPV) Ring is an antiretroviral vaginal ring pioneered by the International Partnership for Microbicides (IPM) pending for regulatory review. It is designed as a long-acting form of HIV prevention for at-risk women, particularly in developing nations such as sub-Saharan Africa. IPM has rights to both the medication and the medical device. A total of four rings with different drug diffusion systems and polymer composition have been developed by IPM. The latest design, Ring-004, is a silicone polymer matrix-type system capable of delivering DPV intravaginally in a sustained manner.
Sharon Louise Hillier is an American microbiologist. She is the Richard Sweet Endowed Chair in Reproductive Infectious Disease and vice chair of the department of obstetrics, gynecology and reproductive sciences at the University of Pittsburgh Medical Center (UPMC) and Magee-Women's Research Institute.
Jeanne M. Marrazzo is an American physician-scientist and infectious diseases specialist. She is the director of the University of Alabama School of Medicine Division of Infectious Diseases and focuses on prevention of HIV infection using biomedical interventions. Marrazzo is also a fellow of the American College of Physicians and Infectious Disease Society of America. On August 2, 2023 Lawrence A. Tabak, acting director for the National Institutes of Health, named Jeanne M. Marrazzo as director of NIH’s National Institute of Allergy and Infectious Diseases.
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