Dallas-based North Texas Infectious Disease Consultants, with a list of health care providers staff touted as the “premier infectious diseases and HIV doctors in Dallas, participated in three current HIV clinical trials, and was recognized at the Conference on Retroviruses and Opportunistic Infections as the “top enroller” for all three trials.
Dr. Christopher Bettacchi, who has been on staff with NTID since 2010, was the principal investigator on two of the studies and was a sub-investigator on the third. He recently took time to answer a few questions for Dallas Voice about the trials, NTID’s participation in them and the importance of these studies.
— Tammye Nash
Dallas Voice: What were the three studies, specifically, that NTID participated in? Were they focused on new drugs or new processes, or were they focused on new combinations of existing medications? Dr. Christopher Bettacchi: At the Conference on Retroviruses and Opportunistic Infections this year, NTID was proud to have been a part of three of the most impactful current HIV clinical trials. These included:
• A Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (known as ARTISTRY-1)
• A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) in HIV-1 Antiretroviral Treatment-naïve Participants (known as MK-8591A-053)
• A Study to Investigate the Virologic Efficacy and Safety of VH3810109 + Cabotegravir Compared to Standard of Care (SOC) in Male and Female Adults Living With Human Immunodeficiency Virus (HIV) (known as EMBRACE).
The first two studies, ARTISTRY-1 and MK-053, are new combinations of existing (albeit relatively new to the market) medications. Both of these combinations are designed to use novel mechanisms to treat the HIV virus.
The third study, EMBRACE, incorporated the new medication “VH33810109” a so-called next-generation broadly neutralizing antibody (bNAb) developed to target HIV.
Explain to me what “broadly neutralizing antibodies means” and why that is a good thing for people with HIV/AIDS? Broadly neutralizing antibodies, or “bnAbs,” are a newer type of treatment that helps the body fight HIV in a smarter way. Unlike typical antibodies, which usually target just one version of a virus, bnAbs can recognize and block many different strains of HIV — even as the virus mutates. That’s important because HIV is very good at changing itself to avoid being attacked.
These antibodies go after parts of the virus that don’t change much, which makes them much more effective over time. For people living with HIV, this could mean longer-lasting treatments that don’t require taking a daily pill.
Some of these therapies are being developed as injections or infusions given every few months, which can make treatment easier to stick with and improve quality of life. While this isn’t a cure yet, it’s a major step forward. It gives us another powerful tool to control the virus and continue moving toward better, more manageable treatment options for patients.
From your perspective, what do you think are the most exciting/most promising results to be reported? And are these studies ongoing or are they complete? The most inspiring results in my view are the number of studies that continue to support the development of long-acting HIV therapies. Whether it is once weekly oral medication, or injectable medications that last months, the emphasis on therapies that are more individualized and less burdensome on patients is exciting to see.
What happens now? Any idea of a timeline for getting these new treatments into action? In other words, how long til these news treatments are available to HIV/AIDS patients in general? After a study is finished, the results are reviewed by the sponsor and government agencies like the FDA to make sure the treatment is safe and works well. For new HIV treatments like broadly neutralizing antibodies, this process can take several years.
If the trials go well, the treatments may first be available in special clinics, and later more widely once fully approved. These drugs are well on the way into some of the last phases. Overall, it usually takes five to 10 years from early trials to general availability, though some patients may get access sooner through special programs.
NTID was the “top enroller” in all three above-mentioned studies. What does that mean, and why is that a good thing for NTID? When the press says NTIDC was the “top enroller,” it means that more patients joined the studies at the NTIDC site than at any of the other participating sites. This is important because it shows NTIDC can recruit and manage patients efficiently, which builds trust with sponsors and can bring more cutting-edge studies to the practice.
That means patients in Dallas get access to the latest clinical trials. It also gives NTIDC staff valuable experience with research, strengthening the site’s reputation in the medical and research community.
How many other agencies/clinics were participating in these studies? The number of participating sites can vary by study, but large HIV clinical trials like the ones NTIDC was involved in often include dozens of clinics and research centers across the U.S. and sometimes internationally.
What is the role of the principal investigator in studies such as these? The principal investigator, or PI, is the doctor in charge of the study at a local site. Their main job is to make sure patients are safe and the study is done correctly. They decide who qualifies for the study, monitor patients during the trial and make sure any issues are handled quickly. They also oversee the research team and ensure everything follows the study rules.
In simple terms, the PI helps protect patients while making sure the research produces reliable results that can lead to better treatments.
Who is it that initiates and funds these studies? Most clinical studies are initiated and funded by pharmaceutical or biotechnology companies, such as Gilead Sciences, ViiV and Merck, that are developing new treatments and want to test their safety and effectiveness. In other cases, studies can be funded by government agencies like the National Institutes of Health or by academic institutions and research foundations.
In simple terms, the sponsor — whoever is funding the study — designs the research and provides the financial support, while clinical sites and physicians carry out the study with patients.
If someone is interested in participating in these or other studies, how do they go about that? If someone is interested in participating in a study, you can look up all trials on ClinicalTrials.gov, which lists all actively recruiting studies.
You can also visit the NTIDC.com website, where you can request information about currently enrolling studies and how to contact the site for more details. From there, the research team can explain eligibility criteria, study requirements, and the enrollment process.
What have I not asked about that is important for my readers to know? Participation in clinical studies is strictly voluntary and carefully regulated to protect patients. Each study is reviewed by an independent board to ensure safety, and participants must meet specific eligibility requirements.
While joining a study can provide early access to promising new treatments, there may be unknown risks or side effects.
Personal and medical information is kept confidential, and participants can leave the study at any time without affecting their regular care.
Studies at NTIDC not only give patients in Dallas early access to cutting-edge HIV treatments but also contribute to broader research that benefits communities worldwide.
The current administration, with its anti-science approach to science, is pushing cuts to funding in all areas of medical research, not to mention cutting funding to treatment programs. How dangerous is this attitude/approach in terms of interrupting or even ending research? How dangerous is this attitude for patients with HIV/AIDS? There have been a lot of important advances in treating HIV/AIDS and other critical and chronic illnesses. Is the current administration’s approach hindering progress? Are they taking us backwards? And if so, how long before we can get back to solid ground? Medical progress — especially in a field like HIV — doesn’t happen by accident. It requires long-term commitment, consistent funding and a partnership between government agencies, researchers, pharmaceutical companies and clinical trial sites. When that support becomes uncertain or funding is reduced, the impact can be very real. Research slows, clinical trials are delayed or cancelled, and fewer new therapies make it to patients.
For people living with HIV, that can be dangerous. While current treatments are very effective, we are still working toward better long-acting therapies, prevention strategies and ultimately a cure. Interruptions in research funding or treatment programs can limit access to care for vulnerable populations and slow the development of the next generation of treatments.
HIV research has moved forward because the scientific community has had sustained support over many decades. If that support weakens, it absolutely risks slowing the pace of discovery and innovation.
That said, the HIV research community has historically been very resilient. Scientists, clinicians, advocacy groups and industry partners remain deeply committed to moving the field forward. Even when there are political or funding challenges, the work continues.
The concern is that delays in research today can translate into treatments or breakthroughs arriving years later than they otherwise would have. For patients waiting on better therapies — or ultimately a cure — those delays matter.