Clinical trial tests new HIV prevention strategy

Vanderbilt has been at the forefront of the fight against HIV prevention for over two decades, and this week marks a major new milestone in that fight, both locally and internationally. Enrollment has just begun in the first of two parallel, multinational clinical trials testing a new strategy in HIV prevention—the Antibody Mediated Prevention (AMP) study. Vanderbilt has just enrolled its first participant, the first to be enrolled by any of the clinics participating in the study in the Americas.

A good deal of research has been devoted to developing a vaccine, which would prompt the immune system to produce broadly neutralizing antibodies: so far developing a vaccine for HIV has defied traditional techniques however. AMP will will deliver broadly neutralizing antibodies directly to a patient through IV infusion.

This would offer insight into the efficacy of the overall vaccine strategy—whether broadly neutralizing antibodies are really the magic bullet of HIV research. “Many scientists believe that if a vaccine were developed that elicited broadly neutralizing antibodies in healthy people, it would protect them from HIV infection,” said National Institute of Allergy and Infectious Diseases (NIAID) Director Anthony S. Fauci, M.D. “The AMP Studies will test this hypothesis by directly giving people the VRC01 antibody.”

The AMP study will also test whether such infusions could offer long-lasting resistance to HIV infection. If the infusion offers weeks or months of resistance, adherence might be higher than with a daily pill, for instance.

“The immediate goal of antibody-mediated prevention of HIV is for each VRC01 infusion to have a protective effect that lasts for many weeks,” said Protocol Chair Myron Cohen, who also serves as associate vice chancellor for global health at the University of North Carolina at Chapel Hill. “Such a long-acting HIV prevention regimen might be easier for some people to follow than a daily regimen of oral medication, as currently required to prevent HIV infection.”

The volunteers in both AMP studies will be adults at high risk for HIV infection, but HIV-negative when they enter the study. In each trial, volunteers will be assigned at random to receive an IV infusion of one of two doses of the antibody or of a saline solution (a placebo). Neither the volunteers nor the study investigators will know who receives which type of infusion until the end of the study. Volunteers will receive a total of 10 infusions, once every 8 weeks, and then will be followed for 20 more weeks. The results of the trials are expected in 2022.

Vic Sorrell, Community Engagement Coordinator for the Vanderbilt HIV Vaccine Program, highlighted a few elements that set this study apart, besides its extreme breadth and scope. “Besides being the first study to work with antibodies directly rather than a vaccine, this study will also be the first to significantly enroll trans-men and -women,” Sorrell said. “This is data that needs to be there in HIV research in general, but it’s woefully lacking.”

While Vanderbilt has already enrolled its first participant, which has been confirmed to be the first in the Americas, Sorrell predicts that the process of getting nearly a hundred participants enrolled will take quite a bit more time.

“This is a study that is only enrolling people who are at significant risk—they obviously want to enroll a community that would be most benefited should there ultimately be an efficacy component, so thats a part of why the process of enrollment is so time consuming,” Sorrell said. “The other thing is, you’re talking about ten infusions, with blood draws in between, over twenty-two months: some people don’t have work schedules or proximity to accommodate that so we have a lot of work ahead!”

For more information about the AMP study and study locations, visit http://www.ampstudy.org/. To see whether you are eligible to volunteer for the Vanderbilt trial, visit http://www.vanderbilthealth.com/HIV-vaccine-program/15069 or contact Vic.Sorrell@Vanderbilt.edu.

 

WhistlePig + Alfa Romeo F1

SHOREHAM, VT (September 13, 2023) — WhistlePig Whiskey, the leaders in independent craft whiskey, and Alfa Romeo F1 Team Stake are waving the checkered flag on a legend-worthy release that’s taking whiskey to G-Force levels. The Limited Edition PiggyBack Legends Series: Alfa Romeo F1 Team Stake Barrel is a high Rye Whiskey selected by the Alfa Romeo F1 Team Stake drivers, with barrels trialed in their wind tunnel to ensure a thrilling taste in every sip.

The third iteration in WhistlePig’s Single Barrel PiggyBack Legends Series, the Alfa Romeo F1 Team Stake Barrel is bottled at 96.77 proof, a nod to Valtteri Bottas’ racing number, 77, and the precision of racing. Inspired by Zhou Guanyu, the first Chinese F1 driver, this Rye Whiskey is finished with lychee and oolong tea. Herbal and floral notes of the oolong tea complement the herbaceous notes of WhistlePig’s signature PiggyBack 100% Rye, rounded out with a juicy tropical fruit finish and a touch of spice.

Keep readingShow less
by Spectrum Medical Care Center

Nurse Practitioner Ari Kravitz

When I started medical transition at 20 years old, it was very difficult to get the care I needed for hormone replacement therapy because there are very few providers trained in starting hormones for trans people, even though it’s very similar to the hormones that we prescribe to women in menopause or cisgender men with low testosterone.

I hope more providers get trained in LGBTQ+ healthcare, so they can support patients along their individual gender journey, and provide the info needed to make informed decisions about their body. I’ve personally seen my trans patients find hope and experience a better quality of life through hormone replacement therapy.

Keep readingShow less

Descanso Resort swimming pool and lounge area

Descanso Resort, Palm Springs' premier destination for gay men, just received Tripadvisor's highest honor, a Travelers' Choice "Best of the Best" award for 2023. Based on guests' reviews and ratings, fewer than 1% of Tripadvisor's 8 million listings around the world receive the coveted "Best of the Best" designation. Descanso ranked 12th in the top 25 small inns and hotels category in the United States. Quite an accomplishment!

Open less than two years, Descanso Resort offers gay men a relaxing and luxurious boutique hotel experience just minutes away from Palm Springs' buzziest restaurants, nightclubs, and shopping. Descanso has quickly established itself as a top destination for sophisticated gay travelers, earning hundreds of 5-star guest reviews and consistently ranking in Trapadvisor's top positions alongside brother properties Santiago Resort and Twin Palms Resort.

Keep readingShow less