IPrEx
Encyclopedia
The iPrEx study was a double-blind, placebo controlled Phase III clinical trial
that began in 2007 following three years of community consultation. iPrEx was the first human efficacy study of pre-exposure prophylaxis
(PrEP) to report efficacy data. iPrEx was sponsored by the U.S. National Institutes of Health
(NIH) through a grant to the J. David Gladstone Institutes, a non-profit independent research organization affiliated with the University of California at San Francisco. Additional support for the study was provided by the Bill & Melinda Gates Foundation
. Study medication was donated by Gilead Sciences
.
and the Bill & Melinda Gates Foundation
through a grant
to the J. David Gladstone Institutes.
Study medication was donated by Gilead Sciences
.
, while the other half received a placebo
.
This result prompted researchers to state that the treatment provided protection against the acquisition of HIV infection, and that there was a correlation
between the presence of study drug in participants' blood and the protective effect.
, an American magazine, named the result of iPrEx to be the most significant medical breakthrough of 2010.
issued a statement by founder Zeda Rosenberg
saying that "The hard work and dedication of the iPrEx team and trial participants has led to a second successful proof-of-concept this year for an ARV-based HIV-prevention product. We must not falter at this important time in history when science shows us that, with sufficient resolve, we can begin to control and potentially reverse the HIV epidemic."
Clinical trial
Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...
that began in 2007 following three years of community consultation. iPrEx was the first human efficacy study of pre-exposure prophylaxis
Pre-exposure prophylaxis
Pre-exposure prophylaxis is any medical or public health procedure used before exposure to the disease causing agent, its purpose is to prevent, rather than treat or cure a disease. An example would be if a doctor gave a medication used to treat a disease to a healthy person who is not thought to...
(PrEP) to report efficacy data. iPrEx was sponsored by the U.S. National Institutes of Health
National Institutes of Health
The National Institutes of Health are an agency of the United States Department of Health and Human Services and are the primary agency of the United States government responsible for biomedical and health-related research. Its science and engineering counterpart is the National Science Foundation...
(NIH) through a grant to the J. David Gladstone Institutes, a non-profit independent research organization affiliated with the University of California at San Francisco. Additional support for the study was provided by the Bill & Melinda Gates Foundation
Bill & Melinda Gates Foundation
The Bill & Melinda Gates Foundation is the largest transparently operated private foundation in the world, founded by Bill and Melinda Gates. It is "driven by the interests and passions of the Gates family"...
. Study medication was donated by Gilead Sciences
Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes therapeutics. For many years since the company was founded, the company concentrated primarily on antiviral drugs to treat patients infected with HIV, hepatitis B or influenza. In 2006, Gilead acquired two...
.
Study organizers
iPrEx was funded by the U.S. National Institutes of HealthNational Institutes of Health
The National Institutes of Health are an agency of the United States Department of Health and Human Services and are the primary agency of the United States government responsible for biomedical and health-related research. Its science and engineering counterpart is the National Science Foundation...
and the Bill & Melinda Gates Foundation
Bill & Melinda Gates Foundation
The Bill & Melinda Gates Foundation is the largest transparently operated private foundation in the world, founded by Bill and Melinda Gates. It is "driven by the interests and passions of the Gates family"...
through a grant
to the J. David Gladstone Institutes.
Study medication was donated by Gilead Sciences
Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes therapeutics. For many years since the company was founded, the company concentrated primarily on antiviral drugs to treat patients infected with HIV, hepatitis B or influenza. In 2006, Gilead acquired two...
.
Study design
Researchers studied 2,499 individuals at risk of HIV infection at study sites in six countries. All study participants received a HIV prevention package to reduce their risk of contracting HIV, including monthly HIV testing, safer sex counseling, condoms and treatment and care for sexually transmitted infections. Half of study participants received an experimental PrEP pill called TruvadaTruvada
Tenofovir/emtricitabine, trademark Truvada, is a fixed-dose combination of two antiretroviral drugs used for the treatment of HIV. It consists of 300 milligrams of tenofovir and 200 milligrams of emtricitabine. By combining the two agents into one tablet, it reduces the pill burden and increases...
, while the other half received a placebo
Placebo
A placebo is a simulated or otherwise medically ineffectual treatment for a disease or other medical condition intended to deceive the recipient...
.
Demographics
Participants in the study were recruited geographically as follows:| Geographical Demographics of IPrEx Recruitment | ||||
|---|---|---|---|---|
| country | study sites | percentage of participants | notes | |
| United States United States The United States of America is a federal constitutional republic comprising fifty states and a federal district... |
Fenway Health Fenway Health Fenway Health, originally called Fenway Community Health Center, is an LGBT health care, research and advocacy organization. It has had a number of homes over the years, including its current Ansin Building home at 1340 Boylston Street in Boston, which opened its doors in 2009... (Boston Boston Boston is the capital of and largest city in Massachusetts, and is one of the oldest cities in the United States. The largest city in New England, Boston is regarded as the unofficial "Capital of New England" for its economic and cultural impact on the entire New England region. The city proper had... ) San Francisco Department of Public Health (San Francisco) |
9% | ||
| Ecuador Ecuador Ecuador , officially the Republic of Ecuador is a representative democratic republic in South America, bordered by Colombia on the north, Peru on the east and south, and by the Pacific Ocean to the west. It is one of only two countries in South America, along with Chile, that do not have a border... |
Fundación Ecuatoriana Equidad Fundación Ecuatoriana Equidad Fundación Ecuatoriana Equidad is a non-profit organization which promotes LGBT rights in Ecuador.-Research:Fundación Ecuatoriana Equidad organized local volunteers to participate in the iPrEx study, which was a clinical trial testing the efficacy of a drug used as a pre-exposure prophylaxis against... (Guayaquil Guayaquil Guayaquil , officially Santiago de Guayaquil , is the largest and the most populous city in Ecuador,with about 2.3 million inhabitants in the city and nearly 3.1 million in the metropolitan area, as well as that nation's main port... ) |
12% | ||
| Peru Peru Peru , officially the Republic of Peru , is a country in western South America. It is bordered on the north by Ecuador and Colombia, on the east by Brazil, on the southeast by Bolivia, on the south by Chile, and on the west by the Pacific Ocean.... |
Asociacion Civil Selva Amazonica (Iquitos Iquitos Iquitos is the largest city in the Peruvian rainforest, with a population of 370,962. It is the capital of Loreto Region and Maynas Province.Located on the Amazon River, it is only above sea level, although it is more than from the mouth of the Amazon at Belém on the Atlantic Ocean... ) Asociación Civil Impacta Salud y Educación Asociación Civil Impacta Salud y Educación Asociación Civil Impacta Salud y Educación is a non-profit organization which promotes public health in the Andean region of Peru.-Research:Asociación Civil Impacta Salud y Educación organized local volunteers to participate in the iPrEx study, which was a clinical trial testing the efficacy of a... (Lima Lima Lima is the capital and the largest city of Peru. It is located in the valleys of the Chillón, Rímac and Lurín rivers, in the central part of the country, on a desert coast overlooking the Pacific Ocean. Together with the seaport of Callao, it forms a contiguous urban area known as the Lima... ) Investigaciones Medicas en Salud (Lima) |
55% | ||
| Brazil Brazil Brazil , officially the Federative Republic of Brazil , is the largest country in South America. It is the world's fifth largest country, both by geographical area and by population with over 192 million people... |
Evandro Chagas Institute Evandro Chagas Institute The Evandro Chagas Institute is a non-profit organization which promotes public health in Brazil.-History:... Oswaldo Cruz Foundation (Rio de Janeiro Rio de Janeiro Rio de Janeiro , commonly referred to simply as Rio, is the capital city of the State of Rio de Janeiro, the second largest city of Brazil, and the third largest metropolitan area and agglomeration in South America, boasting approximately 6.3 million people within the city proper, making it the 6th... ) Projecto Praca Onze (Rio de Janeiro) University of São Paulo University of São Paulo Universidade de São Paulo is a public university in the Brazilian state of São Paulo. It is the largest Brazilian university and one of the country's most prestigious... (São Paulo São Paulo São Paulo is the largest city in Brazil, the largest city in the southern hemisphere and South America, and the world's seventh largest city by population. The metropolis is anchor to the São Paulo metropolitan area, ranked as the second-most populous metropolitan area in the Americas and among... ) |
15% | ||
| Thailand Thailand Thailand , officially the Kingdom of Thailand , formerly known as Siam , is a country located at the centre of the Indochina peninsula and Southeast Asia. It is bordered to the north by Burma and Laos, to the east by Laos and Cambodia, to the south by the Gulf of Thailand and Malaysia, and to the... |
Research Institute for Health Sciences (Chiang Mai Chiang Mai Chiang Mai sometimes written as "Chiengmai" or "Chiangmai", is the largest and most culturally significant city in northern Thailand. It is the capital of Chiang Mai Province , a former capital of the Kingdom of Lanna and was the tributary Kingdom of Chiang Mai from 1774 until 1939. It is... ) |
5% | ||
| South Africa South Africa The Republic of South Africa is a country in southern Africa. Located at the southern tip of Africa, it is divided into nine provinces, with of coastline on the Atlantic and Indian oceans... |
Desmond Tutu HIV Foundation Desmond Tutu HIV Foundation The Desmond Tutu HIV Foundation is a nonprofit organization founded to provide treatment for and conduct research relating to HIV. It is based in Cape Town, South Africa and is managed with the Desmond Tutu HIV Centre at the University of Cape Town... (Cape Town Cape Town Cape Town is the second-most populous city in South Africa, and the provincial capital and primate city of the Western Cape. As the seat of the National Parliament, it is also the legislative capital of the country. It forms part of the City of Cape Town metropolitan municipality... ) |
4% | ||
| total | 100% | |||
Study results
Of the 1248 study participants who received the placebo, researchers found that 64 became HIV infected. There were 36 HIV infections among the 1,251 participants who received Truvada, so there was an average reduction in HIV infection risk of 43.8%. This number includes study participants who did not take their daily pill consistently.This result prompted researchers to state that the treatment provided protection against the acquisition of HIV infection, and that there was a correlation
Correlation
In statistics, dependence refers to any statistical relationship between two random variables or two sets of data. Correlation refers to any of a broad class of statistical relationships involving dependence....
between the presence of study drug in participants' blood and the protective effect.
Popular media
TimeTime (magazine)
Time is an American news magazine. A European edition is published from London. Time Europe covers the Middle East, Africa and, since 2003, Latin America. An Asian edition is based in Hong Kong...
, an American magazine, named the result of iPrEx to be the most significant medical breakthrough of 2010.
CDC statement
The Centers for Disease Control responded to the test results with the following cautions -- PrEP has only been shown to reduce HIV infection among men who have sex with menMSMMSM may refer to:in science and technology:* Methylsulfonylmethane, a chemical compound* Markov switching multifractal, a financial model of asset returns* Method of simulated moments, a statistical estimation technique...
, and not heterosexuals or injecting drug usersDrug injectionIn substance dependence and recreational drug use, drug injection is a method of introducing a drug into the body with a hollow needle and a syringe which is pierced through the skin into the body... - Truvada is the only PrEp to have been tested
- PrEP is only for the HIV-negative
- PrEP should be the last defense against HIV after considering options to do the following:
- Use condoms
- Get HIV tested regularly
- Get tested for other sexually transmitted infections
- Get harm reductionHarm reductionHarm reduction refers to a range of public health policies designed to reduce the harmful consequences associated with recreational drug use and other high risk activities...
education - Reduce one's number of sexual partners
- PrEP has been shown to be effective for those taking it daily and ineffective for people who forget or skip doses
- PrEP must be used with supervision from a medical provider who is specifically knowledgeable about HIV topics
International Partnership for Microbicides
The International Partnership for MicrobicidesInternational Partnership for Microbicides
The International Partnership for Microbicides or IPM is a non-profit product development partnership founded by Dr. Zeda Rosenberg in 2002 to prevent HIV transmission by accelerating the development and availability of a safe and effective microbicide for use by women in developing...
issued a statement by founder Zeda Rosenberg
Zeda Rosenberg
Zeda F. Rosenberg, Sc.D., microbiologist, epidemiologist and widely recognized expert in HIV biology and prevention, serves as the chief executive officer of the International Partnership for Microbicides . IPM was founded by Dr...
saying that "The hard work and dedication of the iPrEx team and trial participants has led to a second successful proof-of-concept this year for an ARV-based HIV-prevention product. We must not falter at this important time in history when science shows us that, with sufficient resolve, we can begin to control and potentially reverse the HIV epidemic."