A nonprofit organization is working on getting health care companies to drop restrictions preventing people who are HIV-positive or who are on PrEP from participating in some clinical trials, such as studies that focus on treating cancer.
Garo Kiledjian, a gay man, is the founder of the Miami-based SGM Alliance (which stands for sexual and gender minorities) and has been its CEO since March 2023. Kiledjian touted that Gilead Sciences, Pfizer, and AstraZeneca are among the pharmaceutical companies that have already joined in the effort.
When writing guidelines for clinical trials, companies had heretofore been copy-and-pasting outdated language that prevented people who were infected with HIV, or who were on antiretrovirals from participating, Kiledjian said.
"There are zero arguments about our position because it's based on fact," he told the Bay Area Reporter in a phone interview.
Kiledjian started working on the matter "four to five years ago" with the world's largest HIV/AIDS health care provider. He was trying to increase LGBTQ representation in clinical trials.
That provider, the Los Angeles-based AIDS Healthcare Foundation, did not return requests for comment for this report.
"I brought in a lot of trials, but we had to exclude every single one because they included this language excluding people on HIV medication," Kiledjian said.
Kiledjian started researching why this language was included.
"It got added in the 1980s and 1990s, and at that time, it did make sense," he said.
Back then, there were few or no medication options for people living with HIV/AIDS. That started to change in the mid-1990s, and has advanced since then.
Kiledjian is not alone in finding the exclusion of HIV-positive people from clinical trials to be a problem. Dr. Tom Uldrick, deputy head of global oncology at the Fred Hutchinson Cancer Center in Seattle, stated that initially "exclusion of people with HIV in clinical trials is a long-standing problem that grew out of the poor outcomes of AIDS patients with cancer, before there were effective antiviral therapies for HIV." Of 46 recent clinical trials that led to the approval of cancer drugs, 30 contained language excluding HIV-positive people, according to the center's website.
In addition to HIV medications, there is also PrEP, which HIV-negative people can take.
PrEP, or pre-exposure prophylaxis, refers to the use of antiviral drugs to prevent people exposed to HIV from becoming infected. The pill Truvada was first approved for PrEP use in 2012 by the U.S. Food and Drug Administration; since then the FDA has also approved the pill Descovy for some groups, and the drug Apretude as an injectable treatment.
Kiledjian started having conversations with scientists in the medical field at various companies. He said that sometimes higher-ups are resistant to change, but that he is still holding out hope for companies that haven't come around yet, and that he declined to name.
In addition to the above-mentioned three companies, others that have signed on are: Abbvie, Amgen, Bristol Myers Squibb, Daiichi-Sankyo, Lilly, Genentech, Syneos Health, StudyKIK, and Takeda. They released a joint statement June 1 to coincide with the beginning of Pride Month.
"Our companies are dedicated to advancing equal representation of sexual and gender minorities (SGM) in clinical research, life sciences, and the evolution of health care," the statement begins. "We seek to mobilize strategy that will drive industry stakeholders to adequately address historical disparities and champion change, allowing LGBTQIA+ individuals to navigate an equitable health care system with dignity."
The companies continued they "are proud to join this initiative, spearheaded by the SGM Alliance, as allies of the organization's mission to amplify SGM voices to ensure that their particular health care needs are addressed and understood."
The companies concluded by asking others to join them.
"In commemoration of Pride Month, we call on other companies in the health care industry to join us in promoting inclusivity and diversity in clinical studies," the statement concludes. "Together, we can break barriers and make history — the time to act is now."
At the end of the day, Kiledjian said that what was most effective was when people at the various companies heard how lifting the restrictions would improve the lives of patients.
"We described patient stories," he said. "We do the work we do to help the end user — the patient. ... What happens to patients, that's the success story."
SGM Alliance also publicized a video featuring gay actor Billy Porter — who is HIV-positive and is grand marshal of the San Francisco LGBTQ Pride parade this year. The video was released June 20.
Updated: June 11, 2024: The headline of this report has been updated to clarify the restrictions have not been lifted yet.
Updated, 6/20/24: This article has been updated to include a link to the Billy Porter video.
LGBTQ Agenda is an online column that appears weekly. Got a tip on queer news? Contact John Ferrannini at [email protected]
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