CAPRISA 004
Encyclopedia
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
.
, 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
infection volunteered to use a study gel in their vaginas, with half of those receiving the microbicide gel and the other half getting placebo according to the result of their randomization. The study asked participants to a first dose of the assigned study gel within 12 hours prior to 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 also assisted in arranging treatment for any sexually transmitted infections which study participants contracted.
The study began in May 2007, was completed in December 2009, and the data collected from the study was published in March 2010. The study design had expected the study to last for 30 months, with about 14 months being used to recruit study volunteers then with follow-up until 92 participants were observed to have become infected with HIV. The entrance criteria for for study was such that based on the risk factors in the participants' lifestyle, the study expected 92 infections to occur approximately 16 months after the study recruited the final volunteer.
.
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."
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."
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, though the CAPRISA 004 trial, we have seen evidence in a human clinical trial that a microbicide can help to prevent sexual transmission."
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.
The principal investigators for the study were Salim S 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.
CAPRISA
CAPRISA is the name of an AIDS research center based in Durban, South Africa.-History:...
. This particular study was the first to show that a topical
Topical
In medicine, a topical medication is applied to body surfaces such as the skin or mucous membranes such as the vagina, anus, throat, eyes and ears.Many topical medications are epicutaneous, meaning that they are applied directly to the skin...
gel could reduce a person's risk of contracting HIV. The gel used in the study contained a microbicide
Microbicides for sexually transmitted diseases
Microbicides for sexually transmitted diseases, are pharmacologic agents and chemical substances that are capable of killing or destroying certain microorganisms that commonly cause human infection, for example the human immunodeficiency virus....
.
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-blindDouble-blind
A blind or blinded experiment is a scientific experiment where some of the people involved are prevented from knowing certain information that might lead to conscious or subconscious bias on their part, invalidating the results....
, randomized
Randomized controlled trial
A randomized controlled trial is a type of scientific experiment - a form of clinical trial - most commonly used in testing the safety and efficacy or effectiveness of healthcare services or health technologies A randomized controlled trial (RCT) is a type of scientific experiment - a form of...
, placebo-controlled study comparing 1% tenofovir gel with a placebo gel. 900 young women who were judged to be at risk of contracting HIV
HIV
Human immunodeficiency virus is a lentivirus that causes acquired immunodeficiency syndrome , a condition in humans in which progressive failure of the immune system allows life-threatening opportunistic infections and cancers to thrive...
infection volunteered to use a study gel in their vaginas, with half of those receiving the microbicide gel and the other half getting placebo according to the result of their randomization. The study asked participants to a first dose of the assigned study gel within 12 hours prior to 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 also assisted in arranging treatment for any sexually transmitted infections which study participants contracted.
The study began in May 2007, was completed in December 2009, and the data collected from the study was published in March 2010. The study design had expected the study to last for 30 months, with about 14 months being used to recruit study volunteers then with follow-up until 92 participants were observed to have become infected with HIV. The entrance criteria for for study was such that based on the risk factors in the participants' lifestyle, the study expected 92 infections to occur approximately 16 months after the study recruited the final volunteer.
Results
Researchers 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.Responses
The results of CAPRISA 004 were formally released at the 18th International AIDS ConferenceInternational AIDS Conference
The International AIDS Society is the custodian of the International AIDS Conference, the largest regular conference on any health or development issue. These conferences provide a forum for the interaction of science, community and leadership, and are claimed to strengthen an evidence-based...
.
Michel Sidibé
Michel Sidibé
Mr Michel Sidibé has been the Executive Director of UNAIDS, the Joint United Nations Programme on HIV/AIDS, and Under-Secretary-General of the United Nations since 1 January 2009....
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."
Anthony Fauci
Anthony Fauci
Anthony S. Fauci is an immunologist who has made substantial contributions to research in the areas of AIDS and other immunodeficiencies, both as a scientist and as the head of the National Institute of Allergy and Infectious Diseases .-Education and career:Anthony Stephen Fauci was born on...
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."
Mitchell Warren, head of the AIDS Vaccine Advocacy Coalition
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...
, remarked that "This is a really historic day for HIV prevention research. For the first time, though the CAPRISA 004 trial, we have seen evidence in a human clinical trial that a microbicide can help to prevent sexual transmission."
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.
Research partnerships
CAPRISA conducted CAPRISA 004 with the following assistance:- the United States Agency for International DevelopmentUnited States Agency for International DevelopmentThe United States Agency for International Development is the United States federal government agency primarily responsible for administering civilian foreign aid. President John F. Kennedy created USAID in 1961 by executive order to implement development assistance programs in the areas...
(USAID) provided funding - the Technology Innovation AgencyTechnology Innovation AgencyThe Technology Innovation Agency is an organization which reviews and promotes government-funded science projects in South Africa.-Projects:The TIA was a coordinating agency in the following projects:...
(TIA), a biotechnology agency of the South African government's Department of Science and Technology, provided funding - Gilead SciencesGilead SciencesGilead 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...
provided tenofovir for the gel used in the study - Family Health InternationalFamily Health InternationalFamily Health International is a public health and development organization dedicated to improving living standards of the world's most vulnerable people. Family Health International has 2,500 staff conducting research and implementing programs in fifty-five countries...
provided technical assistance such as clinical trial protocolClinical trial protocolA clinical trial protocol is a document that describes the objective, design, methodology, statistical considerations, and organization of a clinical trial...
development, clinical monitoringClinical monitoringClinical monitoring - Oversight and administrative efforts that monitor a participant's health during a clinical trial. The government and other clinical trial funding agencies require data and safety monitoring boards to oversee clinical trials...
, and clinical study design - CONRADCONRAD (organization)CONRAD is a non-profit organization which seeks to improve reproductive health, especially in developing countries. It does this by promoting clinical research, particularly that research which involves microbicides for sexually transmitted diseases....
provided consulting related to microbicides
The principal investigators for the study were Salim S Abdool Karim and Quarraisha Abdool Karim, both of the University of KwaZulu-Natal
University of KwaZulu-Natal
The University of KwaZulu-Natal or UKZN is a university with five campuses all located in the province of KwaZulu-Natal in South Africa. It was formed on 1 January 2004 after the merger between the University of Natal and the University of Durban-Westville.-History:-University of...
. The study was conducted at the eThekwini Clinical Research Site in Durban
Durban
Durban is the largest city in the South African province of KwaZulu-Natal and the third largest city in South Africa. It forms part of the eThekwini metropolitan municipality. Durban is famous for being the busiest port in South Africa. It is also seen as one of the major centres of tourism...
, 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...
and the Vulindlela Clinical Research Site in Pietermaritzburg
Pietermaritzburg
Pietermaritzburg is the capital and second largest city in the province of KwaZulu-Natal, South Africa. It was founded in 1838, and is currently governed by the Msunduzi Local Municipality. Its "purist" Zulu name is umGungundlovu, and this is the name used for the district municipality...
, South Africa.