CINCINNATI -- The University of Cincinnati is taking steps that could help combat the spread of HIV infections around the world.
A clinical trial at UC is currently currently enrolling volunteers to test whether an investigational drug is as safe and effective as the FDA-approved Truvada at protecting individuals from HIV.
The new drug cabotegravir (CAB) would be primarily offered as an injectable once every two months versus Truvada, which is given orally each day as a pill.
“We are trying to get an alternative to having to take the pill every day to prevent HIV," said Dr. Carl Fichtenbaum, the trial's principal investigator at UC. "That’s attractive to some people who don’t want to have to remember to take a pill every day if they can take an injection every couple of months."
UC is part of the multinational study launched by the HIV Prevention Trials Network to evaluate whether CAB can safely prevent men who have sex with men and transgender women who have sex with men from acquiring HIV.
Fichtenbaum, a professor in UC's Division of Infectious Diseases, said sites all around the world will enroll up to 4,500 people, including about 100 in the Tri-State area for more than four years. He said he hopes this study and other efforts will help slow the spread of HIV in the Cincinnati area.
Currently, Truvada is approved in the United States for HIV pre-exposure prophylaxis as part of a daily regimen. As part of the study, one group will receive CAB as a pill and a placebo pill for Truvada every day for the first five weeks. This group will also receive a CAB injection monthly for two months, and then for every two months afterward along with a daily placebo pill for Truvada for up to three and a half years.
A second group will be given a real Truvada pill and a placebo pill for CAB every day for five weeks. A placebo CAB injection will follow with real Truvada pills every day for up to three and a half years. Three and a half years into the study, all participants in both groups will receive the real Truvada pill.
“If people know what they are getting, then they change their behavior and that changes the outcome of the study,” Fichtenbaum said in a news release. “This is a way to take people’s behaviors out of it. Now clearly some people won’t take their pills. That’s been true on every study. We will try to convince them, but humans are humans and they do what they are going to do.”
The randomized double blind trial is designed for HIV negative gay men or HIV negative transgender women who have sex with men. All participants must be over age 18.
Jaasiel Chapman, clinical research community educator in the UC Division of Infectious Diseases, said study participants will be offered screening for sexually transmitted diseases along with counseling. They will also receive condoms to encourage the practice of safer sex.
Researchers in the study don’t know if CAB works to protect individuals from HIV exposure. That message will be conveyed to participants in the study designed to determine the efficacy of CAB as an alternative to daily doses of Truvada, which can be more than 90 percent protective against exposure to HIV infection.
“So essentially you have a timed release of the medication that is injected into the body, and the medicine releases slowly over time lasting at pretty high levels for the full eight weeks,” said Fichtenbaum, who is also a UC Health infectious diseases physician.
The most common side effects in people taking Truvada to reduce the risk of becoming infected with HIV include abdominal pain, headache and decreased weight.
Previous studies have shown the most common side effects for individuals taking an injectable cabotegravir have been pain at the location of the injection, swelling and nodules; other side effects have also included fever, fatigue, flu-like illness, headache and rash, according AIDSinfo, a website maintained by the U.S. Department of Health and Human Services.
African-American men who have sex with men have a one in two chance of contracting HIV within their lifetime and this population is among the groups Fichtenbaum says he hopes to enroll in the study. White men who have sex with men have a one in six chance of contracting HIV within their lifetime, says Fichtenbaum.
In the Cincinnati Metropolitan Statistical Area, there are between 3,000 and 5,000 people living with HIV and 10 to 20 percent do not know they are infected, according to Fichtenbaum. He said there are between 150 and 200 new infections locally each year.
Nationally, about 1.2 million Americans live with HIV and about 50,000 new infections occur annually, according to the Centers for Disease Control and Prevention.
The study is being funded by the Division of AIDS in the National Institute of Allergy and Infectious Disease and collaborators include ViiV Healthcare and Gilead Sciences. ViiV Healthcare produces cabotegravir while Gilead Sciences is the maker of Truvada. The official study number is HPTN 083. For more information please visit the website here.
Fichtenbaum receives research grants from Gilead Sciences and ViiV Healthcare, and he has given continuing medical education talks for clinical care options funded by ViiV Healthcare.
For more information about enrolling in the trial please contact Jaasiel Chapman at firstname.lastname@example.org or call 513-584-6279.