CAPRISA 004 is the name of a clinical trial conducted by
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 Comprehe ...
. This particular study was the first to show that a
topical
A topical medication is a medication that is applied to a particular place on or in the body. Most often topical medication means application to body surfaces such as the skin or mucous membranes to treat ailments via a large range of classes ...
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
The phases of clinical research are the stages in which scientists conduct experiments with a health intervention to obtain sufficient evidence for a process considered effective as a medical treatment. For drug development, the clinical phases ...
,
double-blind
In a blind or blinded experiment, information which may influence the participants of the experiment is withheld until after the experiment is complete. Good blinding can reduce or eliminate experimental biases that arise from a participants' expec ...
,
randomized
In common usage, randomness is the apparent or actual lack of pattern or predictability in events. A random sequence of events, symbols or steps often has no order and does not follow an intelligible pattern or combination. Individual ra ...
,
placebo-controlled study
Placebo-controlled studies are a way of testing a medical therapy in which, in addition to a group of subjects that receives the treatment to be evaluated, a separate control group receives a sham "placebo" treatment which is specifically designed ...
comparing 1%
tenofovir
Tenofovir disoproxil, sold under the trade name Viread among others, is a medication used to treat chronic hepatitis B and to prevent and treat HIV/AIDS. It is generally recommended for use with other antiretrovirals. It may be used for preven ...
gel with a placebo gel. 900 young women who were judged to be at risk of contracting
HIV
The human immunodeficiency viruses (HIV) are two species of ''Lentivirus'' (a subgroup of retrovirus) that infect humans. Over time, they cause acquired immunodeficiency syndrome (AIDS), a condition in which progressive failure of the immune ...
volunteered to use a study gel in their
vaginas
In mammals, the vagina is the elastic, muscular part of the female genital tract. In humans, it extends from the Vulval vestibule, vestibule to the cervix. The outer vaginal opening is normally partly covered by a thin layer of mucous membrane ...
, 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
A condom is a sheath-shaped barrier device used during sexual intercourse to reduce the probability of pregnancy or a sexually transmitted infection (STI). There are both male and female condoms. With proper use—and use at every act of inte ...
. The study assisted in arranging treatment for any
sexually transmitted infections
Sexually transmitted infections (STIs), also referred to as sexually transmitted diseases (STDs) and the older term venereal diseases, are infections that are spread by sexual activity, especially vaginal intercourse, anal sex, and oral se ...
that participants contracted.
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.
Results
Researchers led by
Quarraisha Karim
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, ...
found that a microbicide containing 1%
tenofovir
Tenofovir disoproxil, sold under the trade name Viread among others, is a medication used to treat chronic hepatitis B and to prevent and treat HIV/AIDS. It is generally recommended for use with other antiretrovirals. It may be used for preven ...
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 Conference
The International AIDS Society (IAS) is the world's largest association of HIV/AIDS professionals, with 11,600 members from over 170 countries , including clinicians, people living with HIV, service providers, policy makers and others. It aims to r ...
.
Michel Sidibé
Dr. Michel Sidibé (born 1952 in Mali) is the Africa Union Special Envoy for the African Medicines Agency (AMA). He was the Minister of Health and Social Affairs of Mali
Mali (; ), officially the Republic of Mali,, , ff, 𞤈𞤫𞤲𞥠...
of
UNAIDS
The Joint United Nations Programme on HIV and AIDS (UNAIDS) (, ONUSIDA) is the main advocate for accelerated, comprehensive and coordinated global action on the HIV/AIDS pandemic.
The mission of UNAIDS is to lead, strengthen and support an ...
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
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' ...
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
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 ...
, 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."
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 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 bi ...
(USAID) provided funding
*the
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 co ...
(TIA), a biotechnology agency of the South African government's Department of Science and Technology, provided funding
*
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 CO ...
provided tenofovir for the gel used in the study
*
Family Health International provided technical assistance such as
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 succe ...
development,
clinical monitoring, and
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 saf ...
*
CONRAD provided consulting related to microbicides
The principal investigators for the study were
Salim Abdool Karim
Salim S. Abdool Karim, MBChB, MMed, MS(Epi), FFPHM, FFPath (Virol), DipData, PhD, DSc(hc) 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 ...
and
Quarraisha Abdool Karim
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, ...
, both of the
University of KwaZulu-Natal
The University of KwaZulu-Natal (UKZN) is a university with five campuses 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. ...
. The study was conducted at the eThekwini Clinical Research Site in
Durban
Durban ( ) ( zu, eThekwini, from meaning 'the port' also called zu, eZibubulungwini for the mountain range that terminates in the area), nicknamed ''Durbs'',Ishani ChettyCity nicknames in SA and across the worldArticle on ''news24.com'' from ...
,
South Africa
South Africa, officially the Republic of South Africa (RSA), is the southernmost country in Africa. It is bounded to the south by of coastline that stretch along the South Atlantic and Indian Oceans; to the north by the neighbouring countri ...
and the Vulindlela Clinical Research Site in
Pietermaritzburg
Pietermaritzburg (; Zulu: umGungundlovu) 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 Zulu name umGungundlovu ...
, South Africa.
References
External links
original press release
{{Microbicides for sexually transmitted diseases
Clinical trials related to HIV
Herpes
Microbicides