What’s Next for HIV Clinical Trials

A look back at the advancements in HIV treatments underscores the need for continued research.

For more than 40 years, drug developers have been dedicated to advancing HIV clinical research in the quest for treatments and, ultimately, a cure. Though there has been considerable progress in treatment options, 39 million people across the globe are infected with HIV, with an estimated 1.3 million new infections in 2022.

Approved treatments and therapies have turned what was once a certain death sentence into a manageable condition for those with the disease. However, for patients who go untreated, HIV remains a fatal disease. With continued evolution and access to treatment, the HIV drug development landscape is ripe with opportunity.

Case in point: Roughly 41% of infectious disease studies are HIV-related, showing significant industry investment across pharmaceutical and biotech companies and government entities. But as the pursuit of a cure races ahead, challenges remain.

Drug developers — from both the government and private sector — can overcome setbacks and accelerate their research by partnering with a contract research organization (CRO) that’s been at the forefront of HIV clinical trials since the earliest days of the epidemic.

Understanding the Evolution of HIV Treatment and Prevention

Knowing and appreciating both the history and current state of HIV drug development is key to unlocking future success. Since the U.S. Food and Drug Administration approved the first antiretroviral treatment (ART) for HIV in 1987, dozens more have been approved, including combination HIV medicines, single-tablet regimens, and, in the U.S., an injectable regimen taken as two shots every two months. Strides have also been made on the HIV prevention front, with approved pre-exposure prophylaxis (PrEP) treatments becoming standard of care.

These approved therapies have been a game changer in the treatment of HIV and the prevention of its spread. But they also present challenges for both patients and drug developers — and underscore the urgent need for a functional cure.

For patients, current HIV treatment regimens are lifelong commitments that require strict adherence. To remain healthy, treatments must be taken exactly as prescribed, or patients risk developing drug resistance and treatment failure.

For drug developers, advances in approved treatments may make already complex patient recruitment more complicated. An increasing number of patients who are at risk of infection are using PrEP as a preventative treatment and are ineligible to participate in trials because they are HIV negative.

Developing Strong Patient Relationships

For any sponsor that is targeting a preventative or therapeutic vaccine for HIV — or a functional cure — successful trials require deep patient engagement. Since the earliest days of the epidemic, HIV patients have staunchly advocated for advancements in treatments, and their voices remain just as important today.

For example, not long ago, it seemed unthinkable that patients would opt for injectable treatments. But we’ve learned from patients that they want a choice — and some desire the option of having to take oral treatments less often. This type of patient input has led to studies focusing on long-acting injectables to better meet patient preferences as their needs evolve.

Partnering with a CRO that’s been active in HIV research enables drug developers to build meaningful relationships with patients and propel effective treatments forward. At the PPD clinical research business of Thermo Fisher Scientific, in addition to our four decades of HIV experience, we offer sponsors an HIV patient advocate who is available to join any suitable study to assist with patient recruitment and support, further elevating the patient’s voice.

Navigating the Nuances of HIV Clinical Trials

Patients aren’t alone in their need for support — sponsors also want a partner who can guide them through the complexities of HIV studies. Patient recruitment and the increasing complexity of clinical trials are the most common challenges, but within the HIV space, studies face a number of further complications.

• Co-infections: The presence of other diseases and the treatments for those diseases can impact HIV and related treatments in patients — and present challenges to drug developers. A CRO with an experienced, global infectious disease team can enable sponsors to adjust to complications presented by co-infections.

• Drug resistance: Levels of HIV drug resistance remain a concern, creating a challenge for drug developers. A partner with HIV expertise can work with sponsors to identify signs of resistance and make suggestions based on prior experience.

• Global scale of the disease: Around the world, attitudes toward HIV, barriers to treatment and regulatory requirements — all which impact drug developers — vary by country. Having the support of a local team with boots on the ground can accommodate sensitivities and mitigate any cultural or regulatory impacts on your study.

• Patient diversity: Ensuring a diverse patient population — which includes people of color, women and the transgender community, to name a few — is key in continuing to develop effective HIV treatments. A CRO with a longstanding commitment to patient diversity in HIV trials can ensure proper representation within your trial.

Partnering with a Strong CRO to Guide You into the Future of HIV Treatments

When developing an HIV asset, you need a well-rounded approach that’s grounded in historical expertise and proven regulatory successes. A strong CRO partner will evolve and improve alongside you to successfully demonstrate the efficacy and importance of your drug — getting it to the patients who need it.

Thermo Fisher Scientific’s PPD clinical research business has been on the front lines of the HIV epidemic since the very beginning, and we’ve supported the development of more than 14 of the primary therapies, single-tablet regimens and antivirals of choice currently available on the market.

As HIV research advances, we are laser-focused on supporting drug developers in the development of the new, better and simplified treatments that deliver effective therapies and improve the lives of those living with HIV — with the ultimate goal of a cure in mind.