ARV gel almost ready to roll out

via the Daily News, by Liz Clarke

In the time it takes parents to see their children grow from birth to adulthood, the vaginal gel containing the antiretroviral tenofovir has been under close and intense scrutiny.

Now nobody is more keen to see the fast-track roll-out of the life-saving microbicide than Professor Quarraisha Abdool Karim.

Research initiated 20 years ago at the Medical Research Council and in the past ten years at Caprisa finally culminated in a definitive proof that a microbicide, namely tenofovir gel, reduces the risk of women contracting HIV.

“Twenty years might sound a long time,” she said this week, “but this sort of science requires painstaking input from every member of the research team. We have had to ensure that every avenue – from concept to proof – has been covered. Now that we can prove that tenofovir gel works, we are looking forward to implementing the next step.”

That next step, awaiting approval from the Medicines Control Council, will test the feasibility of integrating tenofovir gel provision into family planning services.

As a principal researcher in the Caprisa 004 scientific research programme, Abdool Karim demonstrated that the gel prevented both HIV and Herpes Simplex Virus (HSV) Type 2 infection.

It’s a finding that has been lauded as one of the most significant scientific breakthroughs in the fight against Aids by WHO, UNaids and several leading organisations

“But there is no time to rest on these laurels,” she says. “There is much work still to do.”

Read the rest.


[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

From Tuskegee to Transparency: An Evolution in the Ethics and Accountability of Clinical Trials Involving Human Subjects

via RH Reality Check, by Anna Forbes and Kate Ryan

People who participate in clinical trials take the enormous step of volunteering to test a product that may be useful and, sometimes, life-saving if it turns out to be effective. They play an irreplaceable role in research to prevent, treat, and sometimes cure illness – as well as to find other ways to improve people’s health and lives.

Trial participants make a profoundly personal contribution and accept potential medical, social, and personal risks on behalf of others. An ethical trial is one that eliminates or minimizes participants’ risks as much as possible, invests in making sure that participants understand clearly what they are volunteering for, and protects their rights at every step.

For example, without clinical trials, we would not have seen recent advances in antiretroviral drugs to treat HIV, long-acting contraceptive choices that allow women greater control over their use, or microbicides that may be able to protect women from HIV.

The United States government has rules to protect people who participate in federally-funded biomedical and behavioral research. The rules vary depending on which agency is supporting the research, but they all share a starting point known as the Common Rule, a set of regulations for all federally-funded research involving human participants, whether it is conducted inside or outside the U.S.

But those rules have not always been in place, and there are some shameful chapters in the history of medical research supported by the United States that include violations of the most basic standards of ethical behavior. This history has left some people deeply suspicious of clinical trials and the motives of those who conduct them. Many explain their suspicion with one word: “Tuskegee.”

Read the rest.


[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

Meet Moses Nsubuga Supercharger: Our New Friendly Rectal Microbicide Advocate!

“The task is hard but with determination we shall win together. Continue to keep the fire burning and remember it can even burn deep in the ocean.”

Moses is an IRMA advocate from Kampala, Uganda. He has been living with HIV since 1994 and is quite the superstar. He is a musician, radio host, TV presenter, actor, and activist who has a passion to fight HIV for people all over the world.

In 2000 he formed The Stigmaless Band - a music and drama group of adolescents living with HIV. Their objectives include encouraging early treatment, treatment adherence, and fighting stigma. The success of the band allowed Moses to collaborate with other community based organizations throughout Uganda and to eventually form a larger group called Joint Adherent Brothers and Sisters Against AIDS (JABASA). JABASA’s mission is to attain equal rights for minority and at-risk groups; to encourage early treatment for adults; and to help HIV positive Ugandans become financially self-sufficient by providing them with small loans to begin small income generating projects.

In 2009 he was contracted by USAID and The AIDS Support Organization (TASO) to host an HIV quiz game on television called “Everybody Wins When We Know the Facts about HIV.” As the show gained popularity and was being broadcast in more and more districts throughout Uganda, he was suspended from this work for opposing a law that he believed would criminalize and oppress minority groups if passed.

This did not slow Moses down! Since then he has become the manager of Searchland Shows, where he organizes music shows to advocate for treatment, condoms, and microbicides as prevention. He has also started an orphanage to look after the children of musicians who have died of AIDS. Currently he supports 34 children.

He believes microbicides have the potential to be one of the best prevention options available. He is very active on the IRMA listserv and always challenging opinions, asking questions, and striving to learn more.

Read more bios on the IRMA website.



[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

Meet Thomas Muyunga: Another New Friendly Rectal Microbicide Advocate!

“When one goes to fish, they go to the water body for fish. With the net one catches all sorts of fish and other debris. Sorting out the fish from debris is part of fishing. Same applies to HIV work. Talk about HIV, engage in activities around mobilising beneficiaries and challenge them to participate fully- make it enjoyable. Show the whole list of HIV fuels. Show how stigma, discrimination and abuse fuel HIV in communities.”

Thomas Muyunga is an IRMA Advocate from Kampala, Uganda. There he is CEO of MARPS (Most At Risk Populations’ Society) In Uganda, an umbrella organization committed to “lasting, enduring, and durable solutions against poverty.” Their work focuses on “PLEASE” - Protection, Lasting sexual-reproductive health practices, Empowerment, Attitude change, Social integration and Education. Thomas loves to mobilize communities and prepare and empower them to fight poverty, discrimination, and HIV.

Thomas has worked in HIV Services Provision since 1993 when he was a student volunteer at Rotary International. He first became aware of microbicides at an STD/STI Clinic at the National Referral Hospital in Uganda. He has since dedicated much time and effort to learning about and advocating for the development of successful microbicides. He will join IRMA as a Project ARM (Africa for Rectal Microbicides) scholarship grantee in Addis Ababa, Ethiopia prior to ICASA 2011 to be part of a working meeting to develop an African rectal microbicide agenda!

He believes rectal microbicides are very important because they bring more attention to anal intercourse and help to create conversation about it. He hopes this will also stimulate talk about the power dynamics of anal intercourse.

His advice for others wanting to become IRMA advocates is to first focus on learning as much as possible about HIV prevention, care and treatment so that you can teach others about these issues. Education will also prepare you to inform planning, programming and policy. We can only move forward if we are educated.

Read more Friendly Rectal Microbicide Advocate bios.



[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

NIH researchers show how anti-HIV drug acts to block herpes virus

via Infotech

"The findings explain the results of a recent clinical trial showing that the anti-HIV drug tenofovir, when it is formulated as a vaginal gel, could reduce the risk of herpes simplex virus (HSV) infections -- as well as HIV infections -- in women.

Tenofovir taken orally had been demonstrated to inhibit reproduction of HIV, but had not been known to block the genital herpes virus.

"HIV infection is closely associated with herpes viral infection. When people with genital herpes are exposed to HIV, they are more likely to become infected than are people who do not carry the herpes virus," said Leonid Margolis, Ph.D., head of the Section on Intercellular Interactions at NICHD and one of the authors of the study. "Human tissues convert tenofovir to a form that suppresses HIV. We found that this form of tenofovir also suppresses HSV. This discovery may help to identify drugs to treat the two viruses even more effectively." Discoveries leading to new uses for previously approved drugs have the potential to save millions of dollars, Dr. Margolis said. New drugs typically undergo years of testing for safety and effectiveness before they are approved for patients. Finding new uses for an approved drug increases the value of the initial investment in testing, because most of the testing has previously been completed."

Read the rest.


[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

Optimal Rectal Microbicide Design

via AIDS: Official Journal of the International AIDS Society, by Herrera, Carolinaa; Cranage, Martina; McGowan, Ian; Anton, Peter; Shattock, Robin J

Objective

Receptive anal intercourse in both men and women is associated with the highest probability for sexual acquisition of HIV infection. As part of a strategy to develop an effective rectal microbicide, we performed an ex-vivo preclinical evaluation to determine the efficacy and limitation of multiple combinations of reverse transcriptase inhibitors (RTIs).

Design

A nucleotide, PMPA (tenofovir), a nucleoside, FTC (emtricitabine), RTIs and two nonnucleoside RTIs, UC781 and TMC120 (dapivirine), were used in double, triple and quadruple combinations against a panel of CCR5-uing and CXCR4-using clade B HIV-1 isolates and against RTI-escape variants.

Methods

Indicator cells and colorectal tissue explants were used to assess antiviral activity of drug combinations.

Results

All combinations inhibited the isolates tested in a cellular model and in colorectal explants and produced, for at least one of the compounds, a change in the dose–response curve. Double and triple combinations incrementally augmented activity, even against RTI-escape mutants, whereas quadruple combinations conferred little further advantage.

Conclusion

The colorectal explant model may be used to identify the best candidate molecules and their combinations at the preclinical stage. Furthermore, this study demonstrates that combinations based on RTIs with different HIV-1 inhibitory mechanisms have potential as colorectal microbicides.


[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

Treatment alone will not win war against HIV

via Cape Argus, by Sipokazi Fokazi

If South Africa is to win the battle against HIV/Aids it cannot rely solely on treatment, and must explore prevention strategies that would target those most at risk, including women and children, a Cape Town scientist and HIV researcher has cautioned.

Professor Linda-Gail Bekker, head of the Desmond Tutu HIV Centre, at UCT, said although the effect of HIV treatment was starting to show with the number of deaths beginning to even out, the country would not win the battle with treatment alone.

Bekker was speaking during a meeting hosted by the Microbicide Media and Communication Initiative, an advocacy group that gathers research in microbicides by a range of organisations.

She warned that reliance on treatment would at some stage become unaffordable and unsustainable.

Finance continued to be a problem for many countries, and paying for antiretroviral drugs was becoming expensive.

“Given the financial difficulties, countries will somehow have to come up with plans on how to bring infection levels down.”

The focus needed to be on strategies that achieved behavioural change.

One of the most important things for South Africa was knowing its epidemic – who was most at risk, who was passing HIV to whom, and where the epidemic was concentrated.

UNAids information was that four population groups remained at risk: men who had sex with men, commercial sex workers, prisoners, and intravenous drug users.

In South Africa, young women and pregnant women could be added to that list.

Bekker suggested targeting, directing and tailoring prevention interventions to reduce infection rates.

“You need to know where most of your infections are occurring, and then to work out how best to intervene. I believe it has been a mistake to think one size fits all,” she said.

One area in which South Africa could start shutting the door was in the mother-to-child transmission of HIV.

“We need to wipe out paediatric infection.”

South Africa could not afford to allow transmission of the virus from mother to child.

“If we don’t prevent this, those children will need treatment for the rest of their lives and it will be expensive for the country. We can bring our mother-to-child HIVinfection rate to below 1 percent.”

Researchers had made great strides in HIV prevention studies, particularly in the field of microbicides.

Bekker said it was important that prevention packages be tailored to population groups that were most at risk.

Such strategies would have to take into account biomedical, behavioural and structural components.

“We are in a very exciting period where a whole range of biomedical technologies are showing partial but significant efficacy. Combinations of these prevention technologies in the future will give people options.”

Among the most promising interventions being researched by the Desmond Tutu HIV Centre and its partners was a rectal microbicide, for those practising anal sex. The proposed study would be carried out here and in other places around the world.



[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

The Pharmacokinetics of Tenofovir Following Intravaginal and Intrarectal Administration of Tenofovir Gel to Rhesus Macaques

via AAC Accepts, by Jeremy Nuttall, Angela Kashuba, Ruili Wang, Nicole White, Philip Allen, Jeffrey Roberts, and Joseph Romano

Abstract

Tenofovir gel (1%) is being developed as a microbicide for the prevention of HIV infection, and has been shown to reduce transmission to women by 39%. The gel also prevents infection in macaques when applied intravaginally or intrarectally prior to challenge with SHIV, but very little pharmacokinetic information in macaques is available to help extrapolate the data to humans, and thus inform future development activities. We have determined the pharmacokinetics of tenofovir in macaques following intravaginal and intrarectal administration of 0.2, 1 and 5% gels. Plasma and vaginal and rectal fluid samples were collected up to 24 hours after dosing, and at 24 hours post dosing biopsies were taken from the vaginal wall, cervix and rectum. Following vaginal and rectal administration, tenofovir rapidly distributed to the matrices distal to the site of administration. In all matrices, exposure increased with increasing dose, and with the 1% and 5% formulations, concentrations remained detectable in most animals 24 h after dosing. At all doses, concentrations at the dosing site were typically 1-2 logs higher than in the opposite compartment, and 4-5 logs higher than in plasma. Exposure in vaginal fluid after vaginal dosing was 58-82% lower than in rectal fluid after rectal dosing, but plasma exposure was 1-2-fold greater after vaginal dosing than after rectal dosing. These data suggest that a tenofovir-based microbicide may have the potential to protect when exposure is via vaginal or anal intercourse, regardless of whether the microbicide is applied vaginally or rectally.



[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

Closure of oral Tenofovir arm in VOICE Pre-Exposure Prophylaxis trial: PrEP as a “niche intervention”?

via Incidence, by Roger J. Tatoud

The Microbicides Trial Network (MTN) September 28th that its VOICE (Vaginal and Oral Interventions to Control the Epidemic, MTN003) HIV Pre-Exposure Prophylaxis (PrEP) prevention study will discontinue the daily oral tenofovir arm of the trial. The decision follows an interim review of the trial’s data by its Data Safety and Monitoring Board (DSMB) which recommended that VOICE stops evaluating the oral tenofovir tablet (TDF, brand name Viread), because it will not be possible for the study to show a difference in effect between the drug and the placebo tablet (futility) for the prevention of HIV infection in the context of that study. Importantly, the DSMB did not found any safety issues associated with the use of TDF in any arm of the trial.

This is the third PrEP trial, after FEM-PrEP and TDF2, for which an interim review of the trial’s data led to a change of course of the study. Because the four other arms of the VOICE trial continue, there are no data available publicly yet to explain why tenofovir would not show effectiveness in this study when three other studies showed a dramatic reduction in the risk of HIV infection with tenofovir alone or in combination with another antiretroviral (see table below). However, Sharon Hillier and Ian McGowan of the Microbicide Trials Network noted that the study’s population – predominately women in their 20’s, could be an important factor.

“If there’s one thing we’ve learned over the years it’s that unmarried women in their 20s are in a very different place in their lives than married women in their 30s. People in different circumstances will make different choices about their use of condoms, their choice of partners and whether or not to use a biomedical prevention product. As we continue the VOICE trial we recognize that there could be many factors that influenced the outcome with oral tenofovir, and even when we have more information available to us, understanding what exactly happened (or not) will not be simple.”

If confirmed (a full analysis of the data will not be available before several months) this would add to the challenge of defining a strategic use for PrEP in the general population or in populations at risk.

Read the rest.



[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

First Phase 1 Double-Blind, Placebo-Controlled, Randomized Rectal Microbicide Trial Using UC781 Gel with a Novel Index of Ex Vivo Efficacy

via PLoS ONE, by Peter A. Anton, Terry Saunders, Julie Elliott, Elena Khanukhova, Robert Dennis, Amy Adler, Galen Cortina, Karen Tanner, John Boscardin, William G. Cumberland, Ying Zhou, Ana Ventuneac, Alex Carballo-Diéguez, Lorna Rabe, Timothy McCormick, Henry Gabelnick, Christine Mauck, Ian McGowan

Objectives:

Successful control of the HIV/AIDS pandemic requires reduction of HIV-1 transmission at sexually-exposed mucosae. No prevention studies of the higher-risk rectal compartment exist. We report the first-in-field Phase 1 trial of a rectally-applied, vaginally-formulated microbicide gel with the RT-inhibitor UC781 measuring clinical and mucosal safety, acceptability and plasma drug levels. A first-in-Phase 1 assessment of preliminary pharmacodynamics was included by measuring changes in ex vivo HIV-1 suppression in rectal biopsy tissue after exposure to product in vivo.

Methods:

HIV-1 seronegative, sexually-abstinent men and women (N = 36) were randomized in a double-blind, placebo-controlled trial comparing UC781 gel at two concentrations (0.1%, 0.25%) with placebo gel (1:1:1). Baseline, single-dose exposure and a separate, 7-day at-home dosing were assessed. Safety and acceptability were primary endpoints. Changes in colorectal mucosal markers and UC781 plasma drug levels were secondary endpoints; ex vivo biopsy infectibility was an ancillary endpoint.

Results:

All 36 subjects enrolled completed the 7–14 week trial (100% retention) including 3 flexible sigmoidoscopies, each with 28 biopsies (14 at 10 cm; 14 at 30 cm). There were 81 Grade 1 adverse events (AEs) and 8 Grade 2; no Grade 3, 4 or procedure-related AEs were reported. Acceptability was high, including likelihood of future use. No changes in mucosal immunoinflammatory markers were identified. Plasma levels of UC781 were not detected. Ex vivo infection of biopsies using two titers of HIV-1BaL showed marked suppression of p24 in tissues exposed in vivo to 0.25% UC781; strong trends of suppression were seen with the lower 0.1% UC781 concentration.

Conclusions:

Single and 7-day topical rectal exposure to both concentrations of UC781 were safe with no significant AEs, high acceptability, no detected plasma drug levels and no significant mucosal changes. Ex vivo biopsy infections demonstrated marked suppression of HIV infectibility, identifying a potential early biomarker of efficacy. (Registered at ClinicalTrials.gov; #NCT00408538)

Read a more detailed description of the study here.


[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

New Microbicide May Block Virus From Infecting Cells

via The University of Utah U News Center

University of Utah researchers have discovered a new class of compounds that stick to the sugary coating of the AIDS virus and inhibit it from infecting cells – an early step toward a new treatment to prevent sexual transmission of the virus.

Development and laboratory testing of the potential new microbicide to prevent human immunodeficiency virus infection is outlined in a study set for online publication by Friday in the journal Molecular Pharmaceutics.

Despite years of research, there is only one effective microbicide to prevent sexual transmission of HIV, which causes AIDS, or acquired immune deficiency syndrome. Microbicide development has focused on gels and other treatments that would be applied vaginally by women, particularly in Africa and other developing regions.

To establish infection, HIV must first enter the cells of a host organism and then take control of the cells’ replication machinery to make copies of itself. Those HIV copies in turn infect other cells. These two steps of the HIV life cycle, known as viral entry and viral replication, each provide a potential target for anti-AIDS medicines.

“Most of the anti-HIV drugs in clinical trials target the machinery involved in viral replication,” says the study’s senior author, Patrick F. Kiser, associate professor of bioengineering and adjunct associate professor of pharmaceutics and pharmaceutical chemistry at the University of Utah.

“There is a gap in the HIV treatment pipeline for cost-effective and mass-producible viral entry inhibitors that can inactivate the virus before it has a chance to interact with target cells,” he says.

Read the rest.


[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

2012 International Microbicides Conference (M2012) in Sydney, Australia

The next International Microbicides Conference will be held in Sydney, Australia from April 15-18th, 2012!

Registration
Registration is not yet open, but to submit an expression of interest, please click here. By submitting this, you will be contacted as soon as official registration opens!

Abstract Submission
The 2012 International Microbicides Conference (M2012) invites papers of high quality in the areas of HIV prevention, with a particular focus on microbicides, oral chemoprophylaxis, and their interface with other prevention strategies. The conference is interdisciplinary, and encourages the full involvement of communities and individuals affected by HIV. Abstract submissions will be reviewed by the Scientific Program Committee for content, presentation, timeliness, and current interest of the topic to M2012 participants. Abstracts are welcomed from researchers, program implementers, policy makers, advocates, and community members, and will be considered for inclusion provided they meet the guidelines below.

Please click here to view the abstract submission guidelines.  Authors should submit abstracts no later than 5pm AEST time on Thursday 17 November 2011. Click here for more information and details about uploading your abstract.

Scholarships
Scholarships are available to attend the 2012 International Microbicides Conference (M2012) in Sydney, Australia.

Scholarships will be offered in four categories that have distinct criteria:
1. Research
2. Community
3. Government Official/Public Health Policy
4. Media (Further details to come - Media scholarships will open 23 September)

Scholarship applications are due 5:00 pm AEST on Thursday 17 November 2011.  Click here for more details about scholarships and to apply.

For any other information about M2012 please go to microbicides2012.org.

[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

2012 International Microbicides Conference Scholarship Opportunity!

via International Microbicides Conference Secretariat

Do you need funding to attend M2012?

The M2012 organisers are pleased to announce that scholarships are available to attend the conference in Sydney, Australia. Scholarships will be offered in four categories that each have distinct criteria:

1. Research
2. Community
3. Government Official/ Public Health Policy
4. Media

Click here to find out how to apply for the scholarship.

For more information please visit the conference website http://www.microbicides2012.org/



[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

The Latest Treatment Action Campaign (TAC) Briefing - Antiretrovirals and Prevention

via the Treatment Action Campaign (TAC), by Catherine Tomlinson and Nathan Geffen

Exciting new evidence has demonstrated the potential of antiretroviral medicines (ARVs) to prevent HIV from being sexually transmitted. This TAC briefing explains the evidence and then discusses policy implications.

Our recommendations

1.The WHO must release its guidelines on serodiscordant couples.
2.People living with HIV should be offered highly active antiretroviral treatment (ART) when their CD4 counts fall below 350 cell/mm3, or if they have an AIDS illness or TB.
3.HIV-positive people in serodiscordant couples should be offered ART irrespective of their CD4 count.
4.For serodiscordant couples trying to conceive, both partners should be offered ARVs until conception is confirmed, after which the HIV-positive partner should continue on ART.
5.Pre-exposure prophylaxis (PrEP) should be made available to sex workers.
6.In other cases, pre-exposure prophylaxis should be made available to HIV-negative people who request it or who will --in the opinion of their nurse or doctor-- likely benefit from it.
7.The rollout of ARVs for prevention must not divert funding away from treatment programmes. Achieving universal access for people with HIV must remain the priority for governments, policy makers and funders.
8.Effective prevention interventions such as voluntary medical male circumcision and ensuring availability of male and female condoms continue to be critically important.

Read the rest.

[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

Sexual Pleasure is Key for Successful Microbicides

via WeNews, by Amy Littlefield

Participants in Kate Morrow's [IRMA Steering Committee Member] recent study may not have felt like they were fighting the global HIV epidemic.

In fact, what they were literally feeling were gels of various consistencies inside their vaginas.

The women in Morrow's Project LINK answered questions after handling the gels, inserting them vaginally, walking around and simulating intercourse with a fake phallus. Did the gel leak out? Did it inhibit the experience . . . or did they actually enjoy it?

Morrow has developed a set of scales to show the range of sensations and experiences women reported. Her goal now is to connect those sensations to data about which gels women would use to prevent HIV. Do they prefer gels that are smooth, thin or thick like hair gel? The answers to those questions could help lead to a microbicide that women will tolerate--and perhaps even enjoy.

For decades, women's health advocates have known that women need a way to protect themselves from HIV that is not dependent on a male partner. Vaginal microbicide gels are among an array of options--including pills, rectal microbicides and vaginal rings--that may one day help. Advocates hope microbicides could even be combined with birth control and help prevent other sexually-transmitted illnesses.

Read the rest.

[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

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Bacterial Bioshield Could Keep HIV at Bay

Via New Scientist.

A LIVING microbicide reduces HIV-like infection in monkeys, and might one day provide women with long-lasting defence against the virus.

Dean Hamer of the National Institutes of Health in Bethesda, Maryland, and colleagues engineered naturally occurring vaginal bacteria to produce the anti-HIV protein cyanovirin-N.

They applied a gel containing the bacteria to the vaginas of rhesus macaques before infecting them by the same route with a hybrid of SIV and HIV. The engineered bacteria cut the infection rate by 63 per cent (Mucosal Immunology, DOI: 10.1038/mi.2011.30).

Human females have 10 times as much of the bacteria as female macaques, so the engineered bacteria could reduce infection rates even more dramatically, says Hamer. Clinical tests could begin in a few years after safety testing.

[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

SAVE THE DATE: M2012 is coming to Sydney, April 2012

The M2012 International Microbicides Conference is fast approaching. The conference will be held at Sydney Convention and Exhibition Centre, Sydney, Australia from Sunday 15 April to Wednesday 18 April 2012. It's time to make sure you mark these dates in your diary. 

Click here to learn more, including deadlines for early bird registration, abstract submissions and scholarship 

For more information or to register your interest please visit the website www.microbicides2012.org.

Also, please be aware that IRMA is working with other partners on a pre-conference - to be held Sunday April 15 before the full conference opening - and an Advocacy Corner. If you are interested, let us know.

[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

Investment in HIV Prevention Research

A report released yesterday by HIV Vaccines and Microbicides Resource Tracking Working Group at the IAS conference in Rome "found that overall investment in HIV prevention R&D had actually increased, with the modest exception of a one percent decline in vaccine R&D. The report documented a total US$1.19 billion investment in research and development (R&D) for four key HIV prevention options: preventive vaccines, microbicides, pre-exposure prophylaxis (PrEP) using antiretroviral drugs, and operations research related to medical male circumcision.":

"2010 has been a year of retrospection, a time for looking back over the 30 years since the first published report of the mysterious illness that would come to be known as AIDS. As sobering as this anniversary has been, it has also been a time for some optimism and calls to end the epidemic. These calls may not be simply wishful thinking, fueled as they have been by promising research results over the past two years in vaccines, microbicides, pre-exposure prophylaxis using antiretrovirals (PrEP), and antiretroviral treatment as prevention—results that have energized the entire HIV prevention field.

The first good news came at the end of 2009, when researchers in the RV 144 Thai vaccine trial reported that a vaccine combination had reduced risk of infection by 31 percent—the first clinical evidence that a preventive AIDS vaccine would be possible. Then, in July 2010, the CAPRISA 004 trial team announced its findings–that use of 1% tenofovir (TDF, also known as Viread®) vaginal gel reduced women’s risk of HIV infection by 39 percent—providing the first proof that a microbicide would be possible. This news was followed in November 2010 by the announcement from the iPrEx trial team that daily oral tenofovir/emtricitabine (TDF/FTC, also known as Truvada®) had reduced risk of HIV infection by an estimated 44 percent overall in men who have sex with men (MSM) and transgender women, and proved for the first time that HIV prevention using PrEP would be possible. And finally, in early 2011, the HIV Prevention Trials Network (HPTN) 052 trial established that use of antiretroviral therapy (ART) by HIV-positive individuals reduced transmission to their partners"

Source: HIV Vaccines and Microbicides Resource Tracking Working Group

[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

Microbicide Trials Network Statement On The Partners PrEP Study And The CDC's TDF2 Study: VOICE Study Will Continue

Via Medical News Today.

Researchers from two major HIV prevention trials announced favorable results of an approach called oral pre-exposure prophylaxis, or PrEP. One of these trials, the Partners PrEP Study, has provided the strongest evidence yet of PrEP's effectiveness.

Information from both studies will need to be fully evaluated before it can be determined what impact they will have on another major trial that is ongoing. Investigators for VOICE - Vaginal and Oral Interventions to Control the Epidemic, and the study's sponsor, the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH), hope to complete their evaluation as soon as possible. In the meantime, the five-arm study involving more than 5,000 women in sub-Saharan Africa will continue as currently designed.

PrEP involves the use of antiretroviral (ARV) drugs commonly used in the treatment of HIV by individuals who are not infected. In the Partners PrEP Study, researchers from the University of Washington and their collaborators in Uganda and Kenya, evaluated the safety and effectiveness of daily use of two ARVs - tenofovir and Truvada®, the brand name for a tablet combining tenofovir and emtricitabine - among men and women in a discordant relationship with a partner who is HIV-positive. The study enrolled 4,758 serodiscordant couples.

There were 62 percent fewer HIV infections among participants assigned to take the ARV tenofovir daily compared to participants who took a placebo tablet, and 73 percent fewer infections among those who took Truvada. In statistical terms, the results leave little doubt they are not due to chance. However, the study was not able to say whether Truvada or tenofovir works better than the other in preventing HIV.

The results came to light during a review conducted by Partner PrEP's independent Data Safety and Monitoring Board (DSMB) just a few days ago, on July 10. The DSMB found the results so compelling that it recommended that it stop testing in the placebo group. The research team will be making arrangements so that participants who had been randomly assigned to take a placebo tablet can instead receive one of the study's active study products. Participants in the other two groups will continue to be followed.

In the second study, a smaller trial that involved 1,200 heterosexual men and women in Botswana, researchers from the U.S. Centers for Disease Control and Prevention (CDC) found that 62.6 percent fewer HIV infections had occurred in the group of participants assigned to take Truvada than in the placebo group. The CDC team will be reporting more details about the findings of the study, known as TDF2, at the International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention in Rome next week.
 
Both sets of results bolster the findings of iPrEx, which late last year provided the first evidence that oral PrEP can help prevent HIV. iPrEx found Truvada - together with a comprehensive HIV prevention package - was safe and 44 (43.8) percent more effective than a placebo tablet for protecting against HIV in men who have sex with men. The two studies' favorable results also raise more questions about what happened with FEM-PrEP. Two months ago, researchers announced the trial would be stopping earlier than planned because an interim review of the study's progress by its data monitoring committee determined that even if the study were to continue, it would not be able to conclude whether or not Truvada is effective in its population of women. The study team is still collecting data. A final report is not expected until late this year or early 2012.

Few conclusions can be drawn from the CDC study concerning the effectiveness of Truvada specifically in women. And although Partners PrEP found tenofovir and Truvada worked well for both men and women, the study provides more information about how these drugs can protect heterosexual men from getting infected than it does about how these drugs can protect women from getting infected from a partner with HIV. That's because in most of the 4,758 couples enrolled (62 percent) it was the male who was the uninfected partner.

VOICE involves 5,029 women from Uganda, South Africa and Zimbabwe. VOICE is testing not only daily use of an ARV tablet - Truvada or tenofovir, but also a vaginal microbicide containing tenofovir in gel form. VOICE is the only trial evaluating both a tablet and a gel in the same study. This design is important for determining how each product works compared to its control (placebo gel or placebo tablet) and which approach women may prefer.
 
Read the rest here.
 
[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

WHO Announces New HIV Strategy for 2011-2015

by Aldona Martinka

According to a news release from the United Nations’ website, the five year strategy that the World Health Organization announced yesterday could prevent as many as 4.2 million new HIV infections and save as many as 2 million lives.

The strategy for the coming years focuses on four strategic directions: “To optimize HIV prevention, diagnosis, treatment and care outcomes”, “to leverage broader health outcomes through HIV responses”, “to build strong and sustainable health systems “, and “to address inequalities and advance human rights.” Within these directions there are many exciting goals, such as reducing stigmatization of those with HIV/AIDS, promoting human rights where abuses are barriers to getting tested and/or treated, and driving the development of new preventative interventions.

The strategy specifically mentions PrEP, ARV therapy as prevention, and microbicides as potentially effective new interventions, and plans to guide countries in implementing these programs when the results of evaluations become widely available.

This strategy, unanimously adopted by the Sixty-Fourth World Health Assembly, will serve as a guide for the actions of the WHO and for governments worldwide in facing the AIDS crisis in the first half of the second decade of the new millennium.

Read the full strategy here, or get more information here.


[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]