International Rectal Microbicide Advocates cheers launch of world's third rectal microbicide trial

October 13, 2010

The world's third rectal microbicide trial launched in Pittsburgh, Pennsylvania today, with sites preparing to open in Boston, Massachusetts, and Birmingham, Alabama soon. Scientists will test the rectal safety and acceptability of tenofovir gel, a microbicide developed for vaginal use that has shown promise for preventing HIV through vaginal intercourse. Depending on the outcome of this new study, tenofovir gel could be further evaluated to determine if it can reduce the risk of HIV among both men and women who engage in receptive anal intercourse.

"International Rectal Microbicide Advocates (IRMA) congratulates the Microbicide Trials Network and its partners on the launch of this very important study - the third Phase I trial in history to look at the safety and acceptability of a microbicide gel applied rectally," said Jim Pickett, IRMA Chair and Director of Advocacy at AIDS Foundation of Chicago. "This brings us another step closer to the development of safe and effective rectal microbicides for use during anal intercourse," he said.

Condoms are considered the gold standard for the prevention of HIV and STDs during sexual intercourse, but not all receptive partners are able or willing to use condoms every time. An act of anal intercourse that is not protected by a condom is 10 to 20 times more likely to result in HIV transmission compared to an act of unprotected vaginal intercourse, due to the fragility of the rectal lining and the large presence of cells targeted by HIV. New methods to protect against the sexual transmission of HIV are urgently needed. Strategies beyond condoms - such as vaccines, oral prevention, and microbicides - will provide individuals with more prevention options.

Microbicides - substances applied topically on the inside of the rectum or vagina - could potentially help prevent the transmission of HIV. The research and development of vaginal microbicide candidates is much more advanced than research on rectal microbicides. Tenofovir gel, for example, is a candidate microbicide specifically developed to prevent vaginal transmission of HIV. In a recent study known as CAPRISA 004, tenofovir gel was found to significantly reduce the risk of HIV among at-risk women who were instructed to use the gel before and after vaginal intercourse. In an ongoing, large-scale effectiveness trial called VOICE - Vaginal and Oral Interventions to Control the Epidemic - researchers from the U.S. National Institutes of Health-funded Microbicide Trials Network (MTN) are testing daily use of tenofovir gel in African women, with results expected in 2013.

This new Phase I rectal microbicide study, known as MTN-007, aims to determine if rectal use of tenofovir gel is safe, and in particular, does not cause cells in the rectum to become more vulnerable to HIV. Investigators will also ask trial participants questions regarding the gel's desirability. MTN-007 will enroll 60 men and women at the University of Pittsburgh, the University of Alabama at Birmingham, and Fenway Health in Boston. Leading the study is Ian McGowan, M.D., Ph.D., of the University of Pittsburgh, who is also co-principal investigator of the MTN and serves as Scientific Vice-Chair of IRMA.

Little is known about tenofovir gel used rectally, but science is advancing our understanding. Laboratory and animal studies involving rectal application of tenofovir gel have suggested it's safe for testing in humans. In fact, MTN researchers have just completed the first Phase I trial with eighteen participants, called RMP-02/MTN-006, in collaboration with the Microbicide Development Program at the University of California, Los Angeles. While results of RMP-02/MTN-006 are not expected until early 2011, researchers have already recommended modifications to the gel's formulation. MTN-007 is evaluating the new formulation, which still contains the same amount of active drug - 1% percent tenofovir - but has a lower concentration of glycerin (an additive found in many types of products) to make it more amenable for rectal use.

"It is very encouraging to see the rectal microbicide field moving forward," said IRMA Community Vice-Chair Kadiri Audu, who also heads up the IRMA Nigeria chapter, "and I look forward to trials taking place in Africa as well." He continued, "Gay men and other men who have sex with men in Africa have high rates of HIV infection, and we know unprotected heterosexual anal sex is relatively common on the continent and contributes a sizable number of HIV infections. As much as we need vaginal microbicides to give women an extra prevention tool, rectal microbicides for the women, men, and transgender individuals who engage in anal intercourse are absolutely essential as well."

While the rectal microbicide field has gained significant momentum, more focus and resources are necessary. In 2010, U.S. $7.2 million is being spent globally on rectal microbicide research. IRMA has calculated that annual investments must increase by 40% from 2011 - 2014, to U.S. $10 million/year and must increase further to U.S. $44 million (a six-fold increase) in the years 2015 - 2020 to ensure a minimum of candidate products are moving through the research pipeline into advanced testing for effectiveness.
-end-
[IRMA is a global network of more than 1,000 advocates, scientists, policy makers and funders from six continents working together to advance a robust rectal microbicide research and development agenda. IRMA is based in the United States at the AIDS Foundation of Chicago - www.aidschicago.org - with chapters in Latin America and Nigeria. For further information on IRMA visit www.rectalmicrobicides.org and read IRMA's new report, From Promise to Product: Advancing Rectal Microbicide Research and Advocacy. The report provides an overview of the maturing rectal microbicide field, updates the resource tracking exercise IRMA last conducted in 2006, and lays out global advocacy goals and objectives.]

International Rectal Microbicide Advocates

Related HIV Articles from Brightsurf:

BEAT-HIV Delaney collaboratory issues recommendations measuring persistent HIV reservoirs
Spearheaded by Wistar scientists, top worldwide HIV researchers from the BEAT-HIV Martin Delaney Collaboratory to Cure HIV-1 Infection by Combination Immunotherapy (BEAT-HIV Collaboratory) compiled the first comprehensive set of recommendations on how to best measure the size of persistent HIV reservoirs during cure-directed clinical studies.

The Lancet HIV: Study suggests a second patient has been cured of HIV
A study of the second HIV patient to undergo successful stem cell transplantation from donors with a HIV-resistant gene, finds that there was no active viral infection in the patient's blood 30 months after they stopped anti-retroviral therapy, according to a case report published in The Lancet HIV journal and presented at CROI (Conference on Retroviruses and Opportunistic Infections).

Children with HIV score below HIV-negative peers in cognitive, motor function tests
Children who acquired HIV in utero or during birth or breastfeeding did not perform as well as their peers who do not have HIV on tests measuring cognitive ability, motor function and attention, according to a report published online today in Clinical Infectious Diseases.

Efforts to end the HIV epidemic must not ignore people already living with HIV
Efforts to prevent new HIV transmissions in the US must be accompanied by addressing HIV-associated comorbidities to improve the health of people already living with HIV, NIH experts assert in the third of a series of JAMA commentaries.

The Lancet HIV: Severe anti-LGBT legislations associated with lower testing and awareness of HIV in African countries
This first systematic review to investigate HIV testing, treatment and viral suppression in men who have sex with men in Africa finds that among the most recent studies (conducted after 2011) only half of men have been tested for HIV in the past 12 months.

The Lancet HIV: Tenfold increase in number of adolescents on HIV treatment in South Africa since 2010, but many still untreated
A new study of more than 700,000 one to 19-year olds being treated for HIV infection suggests a ten-fold increase in the number of adolescents aged 15 to 19 receiving HIV treatment in South Africa, according to results published in The Lancet HIV journal.

Starting HIV treatment in ERs may be key to ending HIV spread worldwide
In a follow-up study conducted in South Africa, Johns Hopkins Medicine researchers say they have evidence that hospital emergency departments (EDs) worldwide may be key strategic settings for curbing the spread of HIV infections in hard-to-reach populations if the EDs jump-start treatment and case management as well as diagnosis of the disease.

NIH HIV experts prioritize research to achieve sustained ART-free HIV remission
Achieving sustained remission of HIV without life-long antiretroviral therapy (ART) is a top HIV research priority, according to a new commentary in JAMA by experts at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

The Lancet HIV: PrEP implementation is associated with a rapid decline in new HIV infections
Study from Australia is the first to evaluate a population-level roll-out of pre-exposure prophylaxis (PrEP) in men who have sex with men.

Researchers date 'hibernating' HIV strains, advancing BC's leadership in HIV cure research
Researchers have developed a novel way for dating 'hibernating' HIV strains, in an advancement for HIV cure research.

Read More: HIV News and HIV Current Events
Brightsurf.com is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to Amazon.com.