The HIV Prevention Pipeline: A Future of Possibilities

via IRMA/AVAC, presented by Jim A. Turpin

Please register for this teleconference.
 
Meeting Description:

In the last two years there has been great progress in ARV-based prevention strategies - both in terms of PrEP and microbicides. Specifically, there has been enormous excitement and promise around two drugs - tenofovir and Truvada. And more recently, studies testing Dapivirine and Maraviroc have gotten underway.

But...  is that all there is?  What is happening in terms of pre-clinical work?

In this teleconference brought to you by IRMA and AVAC, the NIH's Jim Turpin will examine current and emerging prevention candidates and delivery systems beyond pills, gels and rings, giving us a fascinating peek into the HIV prevention pipeline that we don't often hear about, well before large efficacy trials are imagined, even before small Phase I safety studies are in the picture.

Jim will ask the questions on all of our minds: Is a sustainable pipeline of HIV prevention products beyond the current array of candidates possible? What does that look like? And what can advocates do to better engage in early, pre-clinical efforts years before human trials are in the picture?

Join our call to hear his answers - and provide your own.

Click here to convert the time of this call to your time zone.

When you register for the call, you will be provided a list of global toll-free dial in numbers., If you need us to dial you into the call, please let us know your number when you register. We will only dial in individuals who don't have access to toll-free numbers.

Presentation slides will be made available on the IRMA website here at least a day in advance of the call. You may download the slides and follow along that way, or simply log in to the ReadyTalk web interface on the day of the call and watch the slides there.

This call will be recorded. The recording will be made available on the IRMA website within a day or two after the call.

Questions? Email IRMA at rectalmicro@gmail.com - thanks!

Register for this meeting here.



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*Also, please note that shared news items from other sources posted on this blog do not necessarily mean IRMA has taken any position on the article's content.
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New, Long-Term PrEP Study Announced

Via Now Chelsea, by Sam Spokony.

Few methods of HIV prevention have been as promising, or as controversial, as pre-exposure prophylaxis (PrEP). After a history of underground practice and off-label prescriptions, the approach has recently begun to receive serious attention from researchers, policy makers and health care advocates.

An outgrowth of post-exposure prophylaxis (or PEP, a short-term antiretroviral treatment that has been used since the early 90s to decrease the likelihood of HIV infection after exposure to the virus, either occupationally or through sex), PrEP is a similar antiretroviral that can be taken by HIV-negative individuals in order to help prevent them from seroconverting (being infected).

The results of a Phase III clinical study known as iPrEx were published in the New England Journal of Medicine on November 23, 2010. The study showed that, in a group of 2,499 gay men, PrEP — in the form of a combination of drugs under the brand name Truvada — was 44 percent effective in preventing HIV seroconversion.

Under the guidance of Dr. Roy Gulick (director of the Weill Cornell Medical College HIV Clinical Trials Unit), a new experiment called the NEXT (Novel Explorations of Therapeutics) PrEP Study will begin this fall. It will include 400 at-risk, HIV-negative gay men, and will take place over 48 weeks at 12 sites across the U.S. and Puerto Rico.

The NEXT PrEP Study will differ from iPrEx in that its primary experimental group will receive a daily regimen of the drug maraviroc (brand name Selzentry). The control group will receive Truvada, and two other experimental groups will receive combinations of maraviroc and either tenofovir or FTC (the two individual drugs that make up Truvada). A major goal of the study, along with testing the HIV-prevention efficacy of maraviroc, will be to gauge the side effects of the drug on participants.

“The longest any HIV-negative person has taken PrEP in a clinical study is 12 weeks,” Gulick told Chelsea Now in a July 23 phone interview [This is actually a major factual error. For example, the average follow-up in iPrEx was 14 months - IRMA]. “Now, since this is a drug we’re giving to healthy people, the next step is exploring further to prove that it is both safe and tolerable for them.”

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.]

Maraviroc showing tantalising promise as (a rectal) microbicide in preclinical studies (CROI)

via Aidsmap, via Gus Cairns

Excerpt: 

n the other presentation, Kevin Brown of the University of North Carolina presented findings of maraviroc concentration in the semen and rectal tissue of male volunteers after oral dosing.

The study used twelve HIV-negative male volunteers, who took an eight-day course of maraviroc dosed at the treatment level of 300mg twice daily.

Blood and semen drug levels were measured five times in twelve hours after a single dose on days one, seven and eight of the study, and also once on days three to six. Rectal biopsy specimens were collected on days one, seven and eight.

After a single dose, semen and blood plasma levels were initially the same but after six hours semen levels fell off more quickly. Trough levels in semen were 70% of blood levels on days 7/8, and the area under the curve (AUC – total drug exposure) in semen was 60% of that in blood. Levels seen after multiple dosing were similar.

Concentrations in rectal tissue were much higher than in blood, with a mean trough level 91 times higher than in blood and the AUC 28 times higher.

Dr Brown said that the rectal tissue levels appeared promising for the use of maraviroc as a rectal microbicide. Levels might be higher because maraviroc was partially eliminated in the faeces.  

Read the whole thing.