To our RVA Friends and Western NY Community

News on April 25th, 2013 Comments Off

We have some important new information from the HVTN 505 vaccine study to share with you.

We are going to stop further injections in the HVTN 505 study because the vaccine did not show efficacy. This means it did not work to prevent HIV infection nor reduce the amount of virus (viral load) in the blood among people in the study who became infected with HIV. Participants enrolled in the study will be unblinded (find out whether they received a vaccine or placebo) in the upcoming few weeks, but study visits will continue.

The first order of business when we heard this news was to notify our study participants (prior to the release of the information to the public). At this time, all RVA HVTN 505 volunteers enrolled in Rochester and Buffalo have been contacted/informed of this important study update.

Although the news is not what we were hoping for, the ongoing support of our volunteers and our community will continue to allow us to better understand how to develop effective HIV vaccines. This news is extremely disappointing to our team, but the information we gain from this study is critical in planning the future direction of HIV vaccine research and we could not have learned this without your support.

Undoubtedly, there will be a lot of news about this study in the upcoming days and weeks. We are committed to providing accurate information to our volunteers and community partners at the earliest possible time. At this time we can provide you the press release sent out today by the National Institute of Health.

http://www.niaid.nih.gov/news/newsreleases/2013/Pages/HVTN505April2013.aspx

As additional information is released we will share this with you. If you have questions or comments about this study or HIV prevention in general, please don’t hesitate to contact us!

Thank you once again for your commitment to ending AIDS!

The entire Rochester Victory Alliance team
855-816-5500
volunteer@rochestervictoryalliance.org

Daily HIV Prevention Approaches Didn’t Work for African Women in the VOICE Study

News on April 11th, 2013 Comments Off

Original article accessed 4/11/13, Microbicide Trials Network: http://www.mtnstopshiv.org/node/4877

Truvada found not an effective strategy in this population
Young, single women were least likely to use tablets or gel, and more likely to get infected at very high rates

ATLANTA, March 4, 2013 – Results of a major HIV prevention trial suggest that daily use of a product – whether a vaginal gel or an oral tablet – does not appear to be the right approach for preventing HIV in young, unmarried African women.

Of the three products tested in the VOICE Study – tenofovir gel, oral tenofovir and oral Truvada^® – none proved to be effective among the 5,029 women enrolled in the trial; most participants did not use them daily as recommended. Drug was detected in less than a third of blood samples from women who were assigned to use either Truvada or oral tenofovir and in less than a quarter of samples from women designated to use gel. Moreover, those least likely to use their assigned products, single women under age 25, were also the most likely to acquire HIV. Incidence in these young women approached nearly 10 percent in some of the study sites in South Africa, a rate considerably higher than expected, according to study results presented at the 20^th Conference on Retroviruses and Opportunistic Infections (CROI) in Atlanta.

“Although there may be other explanations for why these products don’t always work to prevent HIV, it’s hard to ignore the fact that so few women in our study used them. Clearly, an approach of daily product use is not going to work for the population of women who participated in VOICE. Equally important, the women in our study—especially in South Africa—experienced rates of HIV acquisition that were much higher than we expected. The bottom line is that this group of young women remains at very high risk of HIV infection, and urgently needs safe, effective and practical HIV prevention methods that they will actually use,” said Jeanne Marrazzo, M.D., M.P.H., who reported the results on behalf of a team of investigators from 15 trial sites in Uganda, South Africa and Zimbabwe.

VOICE – Vaginal and Oral Interventions to Control the Epidemic – was conducted by the U.S. National Institutes of Health-funded Microbicide Trials Network (MTN) and led by Zvavahera Mike Chirenje, M.D., of the University of Zimbabwe in Harare, and Dr. Marrazzo, from the University of Washington in Seattle.

“No intervention is going to be effective if it’s not used, and the point is that the majority of women in VOICE didn’t use any of the study products as recommended. So, while we are disappointed in these results, we have answered the questions VOICE was designed to answer, and what we have learned is critically important.”

Dr. Chirenje added.

Although other studies in other populations have shown that with consistent use, both oral Truvada and oral tenofovir are highly effective for reducing the risk of HIV, the VOICE results confirm those of the FEM-PrEP study, which tested daily use of Truvada and involved a very similar population of women. As in VOICE, most FEM-PrEP participants didn’t follow the daily regimen.

VOICE, which began enrolling women in September 2009, was designed to evaluate whether antiretroviral (ARV) drugs commonly used in treating HIV are safe and effective in preventing sexual transmission of HIV in women as either a vaginal gel or an oral tablet used daily, an approach called oral pre-exposure prophylaxis, or PrEP. VOICE originally had five study groups. Participants were randomly assigned to use either tenofovir gel or a placebo gel (with no active ingredient), or one of three tablets: tenofovir (known by the brand name Viread^®), Truvada (the brand name for a tablet containing both tenofovir and emtricitabine) or an oral placebo. Participants were asked to use their assigned products daily, and all received ongoing HIV risk-reduction counseling, condoms, and diagnosis and treatment of sexually transmitted infections (STIs) – standard approaches for reducing the risk of HIV – throughout the trial.

In late 2011, VOICE stopped testing oral tenofovir and tenofovir gel after separate routine reviews of study data by an independent group of experts determined that while each was safe, neither was effective in preventing HIV compared to the matched placebos among the women in those groups. Because the study was ongoing and still blinded, study investigators did not know why these products were not effective. VOICE continued to evaluate Truvada until the scheduled end of the study in August 2012.

At CROI, Dr. Marrazzo reported that 312 of the 5,029 women enrolled in VOICE acquired HIV during the study, for an overall HIV incidence of 5.7 percent, nearly twice the rate that investigators had expected when they designed the trial. (Another 22 women were later identified to be infected at enrollment and excluded from the analysis, which was based on 5,007 participants.) HIV incidence, which reflects the number of women who become newly infected for every 100 participants in a given year, ranged from 0.8 percent in Zimbabwe, to 2.1 percent in Uganda, to 7 percent in South Africa. It was nearly 10 percent at some South African trial sites.

No safety concerns were identified for any of the products, yet the study found that, like oral tenofovir and tenofovir gel, daily use of Truvada was not an effective strategy, with 61 of 994 women in the Truvada group acquiring HIV (4.7 percent HIV incidence) compared to 60 of 1,008 in the oral placebo group (4.6 percent incidence).

Of the 1,002 women in the oral tenofovir group, 60 acquired HIV. HIV incidence, however, was calculated to reflect what had occurred up until Oct. 3, 2011, when sites began informing participants that testing of oral tenofovir was to stop. At this time, there were 52 infections in the tenofovir tablet group and 35 in the oral placebo group, for HIV incidence rates of 6.3 and 4.2 percent, respectively. Of the 1,003 women assigned to use tenofovir gel, 61 women acquired HIV (5.9 percent HIV incidence), and 70 infections occurred among the 1,000 women in the placebo gel group (6.8 percent HIV incidence). Though the estimates of effectiveness for both oral tenofovir and Truvada were less than zero, tenofovir gel was estimated to reduce the risk of HIV by 14.7 percent compared to the placebo gel, but with a confidence interval indicating the level of effectiveness could be between -21 percent and 40 percent, this finding was not statistically significant.

An analysis of blood samples from a subset of 773 participants (including 185 women who acquired HIV) found adherence to product use was low across all groups: drug was detected in 29 percent of blood samples from women in the Truvada group, 28 percent of samples in the oral tenofovir group and 23 percent among those in the tenofovir gel group. In sharp contrast, adherence to product use was calculated to be about 90 percent based on what the participants themselves had reported to trial staff and on monthly counts of unused gel applicators and leftover pills.

Perhaps most concerning to the researchers were the study’s findings highlighting the gravity of the epidemic in a population that continues to be among the most vulnerable: young, single women. HIV incidence was 8.8 percent for unmarried women younger than 25 compared to 0.8 percent for older women who were married, differences that were statistically significant. Moreover, young, single women were much less likely to use their assigned study product. In the Truvada group, for example, drug was detected in the blood of just 21 percent of younger, single women compared to 54 percent of those married and over age 25.

The team hopes to understand why women did or did not use the products, including how perception of HIV risk may have played a role. Analysis is ongoing of two qualitative behavioral studies, VOICE C and VOICE D, with results expected in the coming months. Examination of drug levels in vaginal fluid is also planned, which should provide greater insight into the relationship between product use and product efficacy, particularly for tenofovir gel.

Other results still to be reported include a secondary analysis that is hoped will provide information about the potential of tenofovir gel to reduce the risk of herpes simplex virus (HSV-2), and results of the Bone Density Sub-study (VOICE B). VOICE B is an observational study in a subset of VOICE participants designed to explore the effects of oral study products on bone health. Participants are being followed until August 2013, and results are expected before the end of the year.

“In VOICE, our primary aim was to determine the safety and effectiveness of vaginal and oral products used daily, but also to learn which approach the women in our study would prefer. They apparently wanted neither,” commented Sharon Hillier, Ph.D., of the University of Pittsburgh School of Medicine, who with Ian McGowan, M.D., Ph.D., is co-principal investigator of the MTN. “Products that are long-acting, such as the dapivirine vaginal ring, which we are evaluating in the ASPIRE study, and that women use for a month at a time, may be more suitable for this vulnerable population.”

Women account for 60 percent of adults with HIV in sub-Saharan Africa, where unprotected heterosexual intercourse is primarily to blame for the region’s heavy HIV burden. Young women are especially vulnerable. Efforts to promote abstinence, monogamy and male condom use haven’t been enough to stop the HIV epidemic nor are these methods feasible in most settings. There is an urgent need for effective strategies that women can control themselves and be willing to use.

Of the 5,029 women enrolled in VOICE, 4,077 were from South Africa, 322 from Uganda and 630 were from Zimbabwe. The mean age was 25.3 (nearly half were younger than 25); and 79 percent of the participants were single. In South Africa, the mean age was 24.7, although more than half (55 percent) were under age 25 and only 8 percent were married. In contrast, the mean age in Uganda and Zimbabwe, was 28.3 and 28.1, respectively; 50 percent of the women enrolled in Uganda were married, while in Zimbabwe, 94 percent were married.

VOICE was funded by the National Institute of Allergy and Infectious Diseases (NIAID), with co-funding from the Eunice Kennedy Shriver Institute for Child Health and Human Development and the National Institute of Mental Health, all components of the U.S. National Institutes of Health. The study products were provided by Gilead Sciences, Inc., of Foster City, Calif., and by CONRAD, of Arlington, Va. Viread (oral tenofovir) and Truvada are registered trademarks of Gilead Sciences. In 2006, Gilead assigned a royalty-free license for tenofovir gel to CONRAD and the International Partnership for Microbicides of Silver Spring, Md.

# # #

Tenofovir and Truvada are both approved for the treatment of HIV when used in combination with other ARVs. In July 2012, the U.S. Food and Drug Administration approved the use of Truvada also for HIV prevention, a decision based largely on the results of two pivotal trials in two different populations – the iPrEx study in 2,500 men who have sex with men (MSM), and the Partners PrEP Study involving 4,758 heterosexual couples in which one of the partners has HIV. In iPrEx, there were 42 percent fewer HIV infections in the Truvada group compared to the placebo group. Partners PrEP, which tested both tenofovir and Truvada, found daily use of Truvada reduced HIV risk by 75 percent and 67 percent with tenofovir. TDF2, a smaller study in 1,200 heterosexual men and women also found Truvada effective, with a 62.6 percent reduction in HIV risk compared to placebo. These same studies also demonstrated that Truvada was more effective in protecting against HIV when the daily regimen was followed consistently. Indeed, Truvada was not effective in the FEM-PrEP Study, and many of its participants, 2,119 women from Kenya, South Africa and Tanzania, didn’t take the tablets.

In July 2012, the World Health Organization (WHO) issued guidance on PrEP for serodiscordant couples (in whom one partner is HIV-infected) and MSM, recommending its use only in the context of demonstration projects. WHO expects to issue formal PrEP implementation guidelines in 2015 that will consider emerging evidence from trials such as VOICE, as well as outcomes of in-country demonstration projects. Information about Truvada and its “real world” use is being collected in open-label trials, such as iPrEx OLE and the Partners Demonstration Project, and in several other demonstration projects and implementation studies taking place in the United States.

Tenofovir gel used before and after sex was found to reduce the risk of HIV by 39 percent in the CAPRISA 004 study, a finding that was considered a major milestone for the field. The study, which involved 889 women at two sites in the KwaZulu-Natal province of South Africa, unexpectedly found that tenofovir gel also reduced the risk of HSV-2 by 51 percent, the first time that any kind of biomedical prevention method was shown to be effective against HSV-2. FACTS 001, an ongoing Phase III trial of the same regimen used in CAPRISA 004 (before and after sex) that plans to enroll 2,900 women at nine South African sites, hopes to replicate the CAPRISA 004 findings, with results expected in 2015. Concurrently, former CAPRISA 004 participants are being invited to enroll in CAPRISA 008, an open-label follow-on study looking at the feasibility of gel delivery through family planning services.

In other MTN studies, researchers are evaluating a reduced glycerin formulation of tenofovir gel. In one trial to be conducted in South Africa and the United States, researchers will examine drug absorption patterns in both rectal and vaginal tissue when the gel is applied either vaginally or rectally, while a Phase II trial, MTN-017, hopes to determine whether the reformulated gel is safe and acceptable as a rectal microbicide among men who have sex with men (MSM) and transgender women in Peru, South Africa, Thailand and the United States. MTN-017, which is the first Phase II trial of a rectal microbicide, is expected to begin mid-2013.

More information about VOICE can be found athttp://www.mtnstopshiv.org/news/studies/mtn003. A summary of other oral PrEP and tenofovir gel studies can be found at www.avac.org.

About the MTN

The Microbicide Trials Network (MTN) is an HIV/AIDS clinical trials network established in 2006 by the National Institute of Allergy and Infectious Diseases with co-funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institute of Mental Health, all components of the U.S. National Institutes of Health. Based at Magee-Womens Research Institute and the University of Pittsburgh, the MTN brings together international investigators and community and industry partners who are devoted to preventing or reducing the sexual transmission of HIV through the development and evaluation of products applied topically to mucosal surfaces or administered orally.

Celebrating National Week of Prayer for the Healing of AIDS

News on March 4th, 2013 Comments Off

Source: RochesterHomePage.net
By: Amy Young
Updated: March 4, 2013

Today kicked off the National Week of Prayer for the Healing of AIDS. 1.2 million people are living with HIV in the United States. One-fifth of them don’t even know it.

Rochester has the second rate of HIV in New York State, outside of New York City.

In Monroe County more than two-thousand people are diagnosed with HIV. A Rochester congregation is hoping to reach those afflicted and those who may not yet realize they are living with the disease.

I’m proud that the church is finally stepping up and coming out of the fog of not wanting to deal with this very very sensitive issue of HIV and AIDS," said Weldon Thomas, Pastor New Bethel C.M.E. Church.

On this Sunday, Pastor Weldon Thomas’s message hopes to reach those dealing with HIV and AIDS.

"We are realizing that our congregations are being affected more and more. The person sitting in the pew next to your may have a family member, we may have a family members who we’ve had to funeralize. People who are now living with HIV and AIDS and so. Pastors are becoming more sensitive to the fact that we must be at the forefront," added Thomas.

New Bethel C.M.E. Church provided free HIV and AIDS screening before and after this morning’s service.

The pastor also shared the pulpit with Dr. Michael Keefer, a professor at the University of Rochester, conducting clinical research A Professor at the University of Rochester conducting clinical research on preventative vaccines that may one day be the answer to the epidemic.

"The relatively, I think, sad part is that we’ve known for a number of years that the African American and Latino communities are bearing a disproportionate burden of the illness. What’s also distressing is also hitting young people, said Dr. Michael Keefer, University of Rochester.

Jackie Dozier with Minority Health Initiatives was also on hand to help guide those seeking help.

"If we can touch the lives of just one person, then we’ve done some service," said Jackie Dozier, Minority Health Initiatives.

As the title suggests the National Week of Prayer for the Healing of AIDS has various programs and services throughout the coming week, not here in Rochester but throughout the country.

To view the source article and a video of the event, visit: http://rochesterhomepage.net/fulltext?nxd_id=375092

Free Community Film Screening and Discussion

Events on February 25th, 2013 Comments Off

National Week of Prayer for the Healing of AIDS 2013

Events on February 18th, 2013 Comments Off

National Week of Prayer for the Healing of AIDS 2013

AIDS and African Americans (from City Newspaper)

News on November 9th, 2012 Comments Off

AIDS and African Americans

(article taken from City Newspaper)

by Tim Louis Macaluso

National and local experts, researchers, health-care workers, and activists will discuss the crisis at a symposium, "HIV/AIDS Crisis Among African Americans" from 9 a.m. to 3 p.m. on Friday, October 19. The event is sponsored by the University of Rochester.

One in 16 African-American men and one in 32 African-American women will learn at some point in their lives that they have HIV, according to the Centers for Disease Control and Prevention. Even though African Americans make up less than 14 percent of the US population, they represent half of all new HIV infections, the CDC says.

While scientists inch closer to a vaccine and other breakthroughs, some health-care experts question whether eradicating the disease is even possible until the underlying causes of the crisis are better understood.

Inequities born out of a mix of racism, homophobia, and poverty are helping the disease spread disproportionately in minority communities, says Cathy Bunce, a symposium panel member and principal HIV investigator with the University of Rochester Medical Center. Rochester residents between the ages of 18 to 26 accounted for most of the new cases in the city in 2010, she says.

The symposium is from 9 a.m. to 3 p.m. in the Rush Rhees Library. It’s free and open to the public.

PhaseOne

Uncategorized on March 30th, 2012 Comments Off

URMC’s HIV Vaccine Clinical Trials Unit Opens Buffalo Office

News on February 24th, 2011 Comments Off

Researchers Look to Western NY for Help in the Search for a Vaccine

February 21, 2011

The Rochester Victory Alliance, the University of Rochester Medical Center’s HIV vaccine clinical trials unit, has opened a satellite clinic in downtown Buffalo to make it easier for volunteers in western New York to participate in ongoing HIV vaccine trials. The office is located at 206 S. Elmwood Ave.

The new location is part of a collaboration with AIDS Community Services of Western NY (ACS), a not-for-profit community-based organization that provides HIV/AIDS education, support and medical services to eight counties in western New York.

“We are excited about bringing HIV preventive services to the Buffalo community and feel fortunate to have found such a great partner as AIDS Clinical Services in Buffalo,” said Rochester Victory Alliance Director Michael Keefer, M.D. “Since the beginning of the AIDS pandemic, ACS has been dedicated to helping people at risk. They share our goal of one day achieving a world without AIDS. While that is still a long way off, they realize that what we all do today can make an important contribution.”

As new HIV/AIDS cases continue to grow each year, the demand for a vaccine is critical. Local and state statistics show that Buffalo and Rochester share similar rates of new HIV infections, with 67 to 69 percent found in men. Over 50 percent of new cases are in people ages 30 to 49, and almost 40 percent are African American. The Centers for Disease Control reports that one in five men who have sex with men are HIV positive and nearly half do not know it. Young men – especially young black men – are least likely to be aware they are infected. Globally, approximately 33 million people live with AIDS today and more than 16 million children have been orphaned due to losing parents to the disease.

The University of Rochester Medical Center was one of the first sites in the nation to conduct HIV vaccine research studies, beginning in 1988. Since then, nearly 1,300 people from the Rochester area have participated in more than 50 vaccine research trials. The Rochester Victory Alliance is a member of the international HIV Vaccine Trials Network, which is supported by the National Institute of Allergy and Infectious Diseases of the U.S. National Institutes of Health. The Rochester Victory Alliance currently works with HIV vaccine research teams in Sao Paulo, Brazil, and South Africa.

For more information about services or volunteering in a trial*, contact the Rochester Victory Alliance at (855) 816-5500, or in Rochester at the University of Rochester Medical Center, 601 Elmwood Ave, Rochester, 14642, (585) 756-2329 (756-2DAY). Visit the Rochester Victory Alliance on Facebook at http://www.RochesterVictoryAlliance.org/and Twitter at http://twitter.com/RocVictAlliance.

*The Rochester Victory Alliance is currently recruiting for a study involving men who have sex with men, the fastest-rising group of new reported HIV/AIDS cases in the U.S. Men interested in volunteering for the study must be between the ages of 18 and 50, healthy, circumcised, sexually active and HIV-negative. Participation requires 10 to 12 confidential office visits, four of which must be at the Victory Alliance in Rochester. Participants will be paid an average of $1,000. The vaccine used in the study is synthetic and cannot cause HIV or AIDS.

For Media Inquiries:
Carole Dowling
(585) 275-0258
Email Carole Dowling

Justin’s Story

Uncategorized on January 19th, 2010 Comments Off

Click here to find out more about volunteering.

Click here to find out more about the science.

HIV vaccine stems from UR foundation

News on January 3rd, 2010 14,923 Comments

Public health officials in Thailand announced on Sept. 24 that an HIV vaccine has shown 30 percent effectiveness in preventing disease in the general Thai public. Preliminary studies that led to the development of the vaccine were performed at UR in the late 1990s.

The vaccine is a combination of two vaccines — one that is intended to kill HIV cells and the other that helps the body to produce antibodies to fight off the disease. It is the first of its kind to show conclusive evidence that a vaccine can work in humans.

Primary investigator of the Rochester HIV Vaccine Trials Unit and Professor of Medicine Michael Keefer helped conduct the preliminary research that eventually led to last week’s findings.

“It’s exciting mainly because it shows that it is possible to prevent HIV in humans,” Keefer said. “For a person like me who lives and breathes this research every day, this is huge. For the average person looking to get a vaccine from their doctor, that is probably years off.”

This is the first vaccine to show even limited potential in preventing HIV in humans. The seven-year study tracked 16,000 HIV-negative men and women ages 18 to 30 in Thailand who received the vaccine.

The study was double-blind, meaning that neither participants nor investigators knew which participants received which form of the vaccine. Of the participants who received the placebo, 74 became infected with HIV compared to 51 participants who received the vaccine.

The vaccine had only a 30 percent success rate, which means it can’t be licensed for use in any country. Most vaccines need to have higher than 95 percent effectiveness to be licensed for use. According to reporting by BBC World, major efforts will be directed toward data analysis of study results to improve the effectiveness of future vaccines.

Keefer has been studying HIV since 1988 when UR was one of only two sites worldwide studying the epidemic. Typically, the HIV Vaccine Trials Unit carries out phase I trials in people. The studies recruit a small number of low-risk volunteers for preliminary studies. Due to the presence of the vaccine unit, Rochester is one of the top cities in the world for participation in the search for an HIV vaccine.

“Now more than ever we need people to support our research efforts,” Keefer said.
UR is currently recruiting volunteers for local studies. UR is also assisting in a nationwide Phase II trial in the United States and Canada. The trial will test 3,000 patients on the effectiveness of a different type of HIV vaccine made from an inactivated cold virus.

Keefer stressed that a major concern in vaccine development is safety.
He explained two primary difficulties in developing an HIV vaccine. First, a vaccine works by activating the immune system against disease. However, HIV targets activated cells in the immune system. Therefore, some earlier HIV vaccine attempts have actually increased the risk of HIV infection instead of decreasing it.

Secondly, the virus is capable of mutating to adapt to the genetic diversities of a given population. For this reason, the Thai strain of the virus looks different from the virus in other parts of the world. In developing a vaccine, scientists are looking to target critical elements of the virus common to all strains.

According to the World Health Organization Web site, HIV has infected more than 60 million people worldwide and continues to spread at a rate of 14,000 new infections each day.

“Despite preventative measures, a new person contracts HIV once every eight seconds,” Keefer said.

Sahay is a member of the class of 2010.