World AIDS Day 2020 Offers New Research Trial for Injectable HIV Treatment

Charlotte Residents Gain Access to National Research Project

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World AIDS Day takes place on Dec. 1 each year. It’s an opportunity for people worldwide to unite in the fight against HIV, to show support for people living with HIV and to commemorate those who have died from an AIDS-related illness.

Globally, there are an estimated 36.7 million people who have the virus. Despite the virus only being identified in 1984, more than 35 million people have died of HIV or AIDS, making it one of the most destructive pandemics in history. This year, individuals living with HIV in the Charlotte, N.C. region have new hope with an injectable HIV treatment.

Rosedale Health and Wellness, in partnership with GlaxoSmithKline and ViiV Healthcare, was selected as one of the U.S. sites for medical trial testing for the SOLAR study, an injectable treatment for HIV. Only 660 patients are expected to participate in this limited study across the country. The current project is called SOLAR, Switch Onto Long-Acting Regimen will be starting in November.

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The study portion will last one year, but it will offer an extension phase for the participants as ongoing treatment. At that time, the patients will move on to open-label treatment while Rosedale will continue to follow up with them until the drug has final approval. The clinical trial will run from November 2020 through March 2023.

Dr. Frederick Cruickshank, medical director and principal investigator at Rosedale Health and Wellness

“This study is a game-changer in HIV treatment for our clients. I am thrilled we were selected to participate and give our patients options in treatment in Charlotte,” said Dr. Frederick Cruickshank, medical director and principal investigator. ”This treatment option reduces compliance issues with daily oral medication, hopefully resulting in higher compliance rates with patients. This can result in an excellent option to use treatment as prevention in preventing the further spread of HIV.”

It’s an exciting development for the patients as it cuts down the multiple drug regimens needed to treat HIV, which normally meant a three-to-four drug regimen. With this program, the patients will be doing a two-drug injectable regimen. The drugs being used in the study are Cabotegravir Long-Acting (LA) and Rilpivirine LA. Instead of taking any pills, patients will receive an injection.

The treatment is a long-acting injectable, with patients receiving two shots every other month with no oral medication for the treatment of HIV, in contrast to multiple pills daily. The shots are administered in the hip and must be injected by a medical provider.

There is no cost to patients to participate in the study and patients will receive free medications, medical care and labs.

In addition, a stipend will be provided for the participants.

A new day in treatment

HIV treatment has changed dramatically from the first antiretroviral medication that was developed in 1987, Azidothymide commonly known as AZT. HIV-positive individuals once took up to 16 pills per day and now that can be eliminated.

This trial is part of the final steps in receiving Federal Drug Administration (FDA) approval. Studies are carefully monitored to ensure safety of the patients. ViiV/GSK submit data to the FDA that shows the study is moving in a safe direction. Once the data is collected at six months, they submit it to the FDA and do a data check to make sure everything is looking sufficient. At that point, they would be allowed to move forward. At the end of the study, they would again compile all the data and submit it and then ask for approval.

“One of the critical issues researchers have discussed over the years is pill fatigue. Pill fatigue is a condition occurring overtime to chronically ill patients who have taken a lot of medication, in which the patient stops taking pills because of the stress of constant pill swallowing. We see our patients longer which is a great thing, however from the patient perspective when you’re taking that pill, you’re reminded every single day, oh yeah, I’m taking this because I have HIV,” said Steven Haynes, clinical research coordinator. An additional benefit of the new treatment is decreasing depression or mental health issues patients are facing when they’re not reminded every day of their HIV status.

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Steven Haynes, clinical research coordinator at Rosedale Health and Wellness

Donella Richardson is in the category of looking forward to not having to take the pills. Richardson was originally diagnosed with HIV over 25 years ago. When she was first diagnosed, she said, “All I knew about AIDS was death, so I thought I was going to die soon. They gave me six months to live. Now I’m turning 50, and I never thought I would see this day. I have been thankful over the years to see a reduction in medication I had to take daily, but to go to no pills — sign me up!  It is like getting my life back, the stress of missing a pill, or packing all my medication, is now gone for me!

“I’m not nervous at all to be in this study,” said Richardson. “I have trusted Dr. Cruickshank with my medical care, being in this study is not only helping me, but I see how I can be part of a bigger impact helping people living with HIV. We know that treatment equals prevention. This drug regimen will help people be more compliant with their medications, remain undetectable and reduce the spread of HIV and maybe finally put an end to this disease.”

(TasP) refers to taking HIV medication to prevent the sexual transmission of HIV. It is one of the highly effective options for preventing HIV transmission. People living with HIV who take their medication daily as prescribed, that get to and keep an undetectable viral load, have effectively no risk of sexually transmitting HIV to their HIV-negative partners.

TasP works when a person living with HIV takes HIV medication exactly as prescribed and has regular follow-up care, including regular viral load tests to ensure their viral load stays undetectable. “Getting people in care and keeping them in care is the goal of my practice. Having new treatment options gives me and other providers the ability to combat HIV with our patients helping select options that met their individual needs,” Cruickshank shared. “Being part of HIV research brings more options to my clients in the Charlotte region.”

For patients interested in participating in research projects, they are eligible to receive primary and specialty care at Rosedale Health and Wellness. Call 704-659-7799 or email shaynes@myrosedalehealth.com for more information.

Rodney Tucker, director of development and advancement at Dudley’s Place, assisted with the compilation of this article.

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