Future Clinical Trial Designs
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HPTN 083 results and standard of prevention?
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HPTN 083 results and standard of prevention?
I’m excited about the news of HPTN 083! I’m wondering what it means for future clinical trial designs- especially vaccine trial designs? What do others think?
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5 Replies
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Should cabotegravir be licensed for PrEP in gay men and trans women right away on the basis of HPTN083 results, or wait until HPTN084 gives an answer for cis women? Can we learn something from the F/TAF experience (label for MSM and transwomen and post-marketing commitment to do a trial in cis women)?
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They usually need more than one efficacy trial to licence a drug.
However considering the different populations, CAB LA could be licensed for MSM and trans women, then the label updated to include cis women when the results become available.
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Am wondering after these results if participants will continue using oral TDF/FTC instead of CAB LA regimen as long as both medications are available.
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<div>https://www.avac.org/long-acting-injectable-cabotegravir new resource with the ins and outs of CAB-LA.
</div><div>Also, there’s a webinar today to discuss 083 results. Details:
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The HIV Prevention Trials Network (HPTN) invites you to join a community webinar to learn the primary results of HPTN 083, a global randomized, controlled, double-blinded study that compared the safety and efficacy of long-acting injectable cabotegravir (CAB LA) to daily oral tenofovir/emtricitabine (TDF/FTC) (Truvada) for pre-exposure prophylaxis (PrEP). The study showed that a PrEP regimen containing CAB LA was superior to oral TDF/FTC for the prevention of HIV acquisition among cisgender men and transgender women who have sex with men.
DATE: Thursday, 16 July 2020
TIME: 7:30am PDT / 9:30am CDT / 10:30am EDT / 11:30AM BRT, ART / 4:30pm SAST, CAT / 5:30pm EAT / 9:30pm ICT
HOST: Melissa Turner, HPTN Community Working Group Chair
MODERATOR: Mitchell Warren, Executive Director, AVAC
PANELISTS:
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- HPTN 083 Protocol Chair – Dr. Raphael Landovitz, UCLA Center for Clinical AIDS Research and Education (CARE)
- HPTN 083 Protocol Co-Chair – Dr. Beatriz Grinsztejn, National Institute of Infectious Diseases Evandro Chagas-Fiocruz
- HPTN 084 Protocol Chair – Dr. Sinead Delany-Moretlwe, Wits RHI, University of Witwatersrand
- HPTN 084 Protocol Co-Chair – Dr. Mina Hosseinipour, UNC Project Lilongwe
- Head of Research & Development, ViiV Healthcare – Dr. Kimberly Smith
- Senior Director, Global HIV Prevention Strategy, ViiV Healthcare – Dr. Alex Rinehart
ADDITIONAL PANELISTS AVAILABLE FOR QUESTION AND ANSWER SESSION:
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NOTE: All lines will be muted. Questions should be submitted through the Zoom chat feature.
Please choose one of the options below to connect to the Zoom webinar.
1. From your computer, click here:
https://zoom.us/j/407585921?pwd=ZkdzclUzUFkxMlhEY05KVWc5NVFDZz09
Hi Daisy,
Is there a way to get this information now that the date is past?
Sylvia
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