What are HIV Clinical Trials & are they right for you? | Tom Villa x Raif Derrazi
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- Опубликовано: 6 июл 2024
- I sat down with Tom to discuss HIV clinical trials (for vaccines, cure & treatment), what they are, how they work and what you need to know before participating in one. Also, what is an Analytic Treatment Interruption and what does it mean for you and your potential sex partners? This and more.
Thomas J. Villa (Tom) works to help end the HIV epidemic by leveraging three decades of experience as a healthcare executive in biotechnology, graduate medical education and community health.
Tom serves as Community Advisor to various teams researching effective strategies to prevent, treat and/or cure HIV including both the HOPE and RID-HIV Martin Delaney Collaboratories for HIV Cure Research. He has special interest in use of behavioral and social sciences research to enhance the impact of biomedical interventions through use of a participant-centered, whole person approach.
Tom is a serial research participant himself. He has been a volunteer participant in more than two dozen HIV clinical studies, including several ongoing observational studies, early phase and Phase 1 interventional trials and those involving analytic treatment interruption. A practicing writer, Tom sees the arts as an untapped means to engage and inform the wider community not typically involved in clinical research.
NIH Clinical Center
clinicalstudies.info.nih.gov/...
ClinicalTrials.gov
clinicaltrials.gov/
ACTG - AIDS Clinical Trials Group
actgnetwork.org/clinical-trial/
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I'm a clinical research coordinator for a multispecialty hospital system and this is such a great video on how to introduce clinical trials and studies and how they function!
Hey Darrell! Thanks for watching and I’m so glad to hear that coming from your position 😁🙏🏽
@@RaifDerrazi just looking this episode. In regards to human clinical HIV trials, Excision BioTherapeutics' EBT-101 and Moderna's combined mRNA-1644 (eOD-GT8 60mer) & mRNA-1564 both appear to an effective sterilizing therapeutic HIV cure and a combined therapeutic HIV vaccine.
[1].
Pending HIV Sterilizing Cure Therapy, *EBT-101* , developed by *Excision BioTherapeutics* .
EBT-101 is the potential sterilizing cure. Excision BioTherapeutics' CEO is Daniel Dornbusch and Excision BioTherapeutics' EBT-101 is currently in human clinical trials and in September 2022, Excision BioTherapeutics dosed their first participant in the EBT-101 Phase 1/2 Trial.
EBT-101 is CRISPR-based, single administered therapy, designed to cut and removing HIV DNA out of human cells. This potential gene editing treatment employs an adeno-associated virus to deliver CRISPR-CAS9 nucleases and dual guide RNAs targeting three sites within the HIV genome that tell the enzymes where to cut.
EBT-101 was initially developed by Dr. Kamel Khalili and researchers at Temple University, located in Philadelphia, Pennsylvania.
Excision BioTherapeutics received an FDA Fast Track Designation, for EBT-101. The Fast Track Designation is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. This process is designed to expedite the development and review of drugs which may demonstrate substantial improvement over available therapy.
With the FDA granting Excision BioTherapeutics a Fast Track Designation for EBT-101. Hopefully, EBT-101 will be available for distribution in a couple of years, as the first three patients were infected with EBT-101 that seeks and destroys lingering pieces of HIV in the body.
The first EBT-101 human clinical Phase I/II trial (NCTO5144386) started last year in September 2022.
At a recent November 20233 presentation in Brussels, Professor Rachel Presti of Washington University St. Louis School of Medicine reported that all three participants in the first dose cohort, regarding EBT-101, have now received HIV therepy. The initial results indicated that no serious adverse events ir dose-limiting toxicities. There were four mild adverse events that nay have been related to the gene therapy, however all were resolved. Two participants experienced transient liver enzymes elevations. None of the three withdraw from the study.
EBT-101 was detectable in the blood of all participants four weeks after receiving a single IV infusion using the first dose level to be evaluated. There was no evidence of "horizontal transmission of gene vector shedding of EBT-101 in two tissue compartments associated with male reproductive function", suggesting the therepy is not passed on in semen, according to Excision BioTherapeutics. These findings support testing of a higher dose of EBT-101 in a second cohort of six people, which will happen this year.
Dr. William Kennedy, Excision BioTherapeutics' Senior Vice President of Clinical Development stated in a press release the " Establishing the safety and bio-distribution of EBT-101 is an important first step in the clinical program. These initial observations provide important clinical data that support the advancement of the EBT-101-001 trial to the next dosing cohort".
The study participants in the EBT-101-001 trial will be followed fir 48 weeks after EBT-101 us administration, and those who are eligible will be assessed for sustained viral suppression after stopping antiretrovirals in an analytical treatment interruption starting at week 12. The first participant, who received EBT-101 in the sumner of 2022, is already well past the 12-week mark, but Excision BioTherapeutics has not provided any further information about his status.
[2].
*Moderna's combined mRNA-1644 (eOD-GT8 60mer) and vaccine+mRNA1574 HIV vaccine* .
This pending combined mRNA HIV vaccine, mRNA1644 (eOD-GT8 60mer) + mRNA1574 (Core-g28v2 60mer), on March 14, 2022, dosed the first patent with a second dose of the combined HIV mRNA vaccine, less than six weeks after launching human trials for the first dosage in January 2022.
After participants in the HIV mRNA vaccination human clinical trials received mRNA-1644, Moderna took a different approach with the second mRNA dosage, with mRNA-1574, by targeting HIV envelope trimmers via mRNA instead of eliciting broad antibodies against the virus. The trial is currently a collaboration between the Cambridge-based biotech, the National Institute of Health and the Division of AIDS within the National Institute if Allergy and Infectious Diseases. This trial is currently testing the pending vaccine in 100 HIV- Negative adults ages 55 and under.
This is following the January 2022 launch of the company's Phase 1 trial for it's other HIV dose, which tested sequential administration of HIV immunogens via mRNA as a way to elicit strong and durable B-cell responses. In therory, B-Cell response will over time develop into more broad and robust neutralizing antibodies.
Fantastic and thank you for this comprehensive information.
You are very welcome 🙏🏽
I hope they finaly make the medicine for cure hiv
🤞
No hope..every year same news
@@ozangkwait for 2030
@@alkeashkeash351Many lives have ended
@@alkeashkeash351we been waiting for 60 years, and we’re still waiting
Great interview and insight!! Always appreciate your succinct questioning!! Thank you!! ❤❤❤
Thank you!!
Great guest
Hey Raif Derrazi, really nice video! I was wondering if I can help you edit your videos and also make highly engaging shorts out of them.
When all of the patient's HIV meds are simultaneously withdrawn for a treatment interruption, the subsequent reemergence of viral load is absent the pressure to mutate around the withdrawn drugs, so it's unlikely that resistance would develop. About 20 years ago, "Structured Treatment Interruptions" were investigated for the possibility of teaching the patient's immune system to be more aggressive in controlling viral load. The result was, even though the immune system did learn to be more aggressive, it was not enough to shift the entire burden for viral load control onto the immune system alone in the long term. The inescapable fundamental problem is that HIV is primarily designed to attack the most critical component in the immune system (CD4 cells) needed to counter attack HIV. Any 'cure' will have to address this specific problem. Until then, meds are blocking the problem.
Thanks for the insights!
Yes, anti-retroviral therapy (HIV meds) block HIV from infecting new cells, but the meds do not clear HIV from the body. That's why different strategies are needed to achieve cure.
Cuando llegara la vacuna?
Hasta hoy dia, todos los intentos a crear una vacuna han fallado, incluyendo un estudio clínico el año pasado. @@finehandic
Treatment has improved but it is still frustrating to know that they have not found a way to completely eliminate the virus from the body in 40 years of the epidemic. If more scientists were engaged in research, there would already be a cure.
I’m hoping that gene editing will finally come up with a cure.
Have you followed American Gene Technology? they seem to be on top of this!@@marcK599.
Gene therapy is being used successfully to treat various forms of cancer. Multiple research teams are working to develop ways to use it to clear HIV from the body. @@marcK599.
Wow he's smart didn't know that about mutations!
How many years to wheat still? Sir
Hope
It’s been 60 years and still same story. I still have Hope! But I don’t see it happening at all
It’s only been 42 years since 1981 when the first cases of HIV were reported. I don’t know where you got 60 years.
HIV is a very tough adversary because 1) it infects the very immune cells that normally protect the body from infection, and 2) within 1-2 days of initial infection, HIV infects cells in various organs and tissues throughout the body where it lays dormant and "hides" from the medications we take to control it. Finding and clearing HIV from these latent reservoirs ("hiding places") has been very challenging. We're making slow but steady progress.
Love the way your so positive you suck
Cure will happen ?
Jesus save us from this deathly disease
Je suis guérie de VIH pas le traitement de mon docteur
Aap Hindi me videos Nahi banate hai
I have started to add subtitles for my videos and then translate them into Hindi. Check my most recent news video. It takes hours to add the correct subtitles so be patient but I am adding them now.
Let me know if it works and you are able to see my news video (Oct 2-Oct 8) with Hindi
All these scientists, doctors, and researchers have been researching for years since the 1980s, and they still have not found a permanent cure for this disease
It seems like it would just be a dream of mine to find a cure
And yes, I agree with those who say that cancer is better..at least it is not stigmatized and also at least I will know when I will die.
Not all patients want to live with this disease and I am one of them
😔😌😞
🤢
100 years of treatment
It's unfair
You are just looking for money
You are looking for protection, and this is excellent
But whoever is harmed, what can he do other than wait for death?
Save those whose lives have turned into darkness. Please do something for God's sake. He is the only one we trust
Make this disease disappear from our bodies. You have all the knowledge. Are you waiting?
We want to take another chance at
A lot of what you’re saying is false. I understand being frustrated but I don’t appreciate misinformation
Study medical fasting only on water for a long period and you will see the wonders. Because it treated almost all chronic diseases, including diabetes, cancer, epilepsy, and all immune diseases.